Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-22 @ 4:41 AM
Study NCT ID:
NCT00577993
Status:
COMPLETED
Last Update Posted:
2020-11-16
First Post:
2007-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D007438', 'term': 'Introns'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D011344', 'term': 'Procarbazine'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D021901', 'term': 'DNA, Intergenic'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D040461', 'term': 'Gene Components'}, {'id': 'D005796', 'term': 'Genes'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011244', 'term': 'Pregnadienediols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nfowler@mdanderson.org', 'phone': '(832) 671-3018', 'title': 'Nathan Fowler,MD, Clinical Professor, Lymphoma-Myeloma', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '10 years', 'description': 'Adverse events reported for the 2 randomized arms and not for the participants without bcl gene rearrangement.', 'eventGroups': [{'id': 'EG000', 'title': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab', 'description': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 67, 'seriousNumAtRisk': 78, 'deathsNumAffected': 19, 'seriousNumAffected': 67}, {'id': 'EG001', 'title': 'Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)', 'description': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 77, 'seriousNumAtRisk': 80, 'deathsNumAffected': 22, 'seriousNumAffected': 77}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 35}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenic Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea / Emisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash / Pruitius', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenic Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 77}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Overall Survival (10 Years) by Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab', 'description': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex'}, {'id': 'OG001', 'title': 'Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)', 'description': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 Years', 'description': 'Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome measures were only being analyzed for the two randomized arms Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab and Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Progression Free Survival (10 Years) by Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab', 'description': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex'}, {'id': 'OG001', 'title': 'Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)', 'description': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 years', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome measures were only being analyzed for the two randomized arms Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab and Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab', 'description': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex'}, {'id': 'FG001', 'title': 'Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)', 'description': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.'}, {'id': 'FG002', 'title': 'Patients Without Bcl Gene Rearrangement', 'description': 'ATT9 cycles; Rituximab 6 cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Conversion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Uninsured', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period: March 1998 to May 2002', 'preAssignmentDetails': '35 participants without Bcl Gene rearrangement were not randomized to the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab', 'description': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex'}, {'id': 'BG001', 'title': 'Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)', 'description': 'Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex.'}, {'id': 'BG002', 'title': 'Patients w/o Bcl Gene Rearrangement', 'description': 'ATT 9 cycles; Rituximab 6 cycles'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '76'}, {'value': '54', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '75'}, {'value': '51', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '70'}, {'value': '52', 'groupId': 'BG003', 'lowerLimit': '19', 'upperLimit': '76'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}]}, {'title': 'United Arab Emirates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Panama', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Malta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Indolent Lymphoma Subtype', 'classes': [{'title': 'FL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG003'}]}]}, {'title': 'MZL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'SLL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Indolent lymphomas characterized by slow-growing B-cell malignancies: Small lymphocyte (SLL), Malignant Zone (MZL), \\& Follicular Lymphoma (FL).', 'unitOfMeasure': 'participants', 'populationDescription': 'No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype'}], 'populationDescription': 'No data collected for Patients w/o bcl gene for rearrangement for the Study Specific Measure Indolent Lymphoma Subtype'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2001-05-22', 'size': 5121815, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-10-16T17:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-22', 'studyFirstSubmitDate': '2007-12-18', 'resultsFirstSubmitDate': '2020-04-09', 'studyFirstSubmitQcDate': '2007-12-18', 'lastUpdatePostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-22', 'studyFirstPostDateStruct': {'date': '2007-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Overall Survival (10 Years) by Treatment', 'timeFrame': '10 Years', 'description': 'Overall Survival is the time from date of treatment start until date of death due to any cause or last Follow-up within 10 years.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Progression Free Survival (10 Years) by Treatment', 'timeFrame': '10 years', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphoma', 'Follicular Lymphoma', 'Indolent Lymphoma', 'Fludarabine', 'Novantrone', 'Mitoxantrone', 'Decadron', 'Dexamethasone', 'Rituximab', 'Anti-CD20', 'IDEC-C2B8', 'Chimeric Anti-CD20 Antibody', 'Interferon', 'Interferon Alpha-2b', 'IFN', 'Doxorubicin', 'Vincristine', 'Bleomycin', 'Cyclophosphamide', 'Etoposide', 'Cisplatin', 'Ara-C', 'Methyl-Prednisolone', 'Procarbazine', 'Prednisone', 'FND'], 'conditions': ['Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'The University of Texas M.D.Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical research study is to compare chemotherapy given with rituximab to chemotherapy followed by rituximab. The safety of both treatment schedules will be studied. Laboratory tests of genetic changes in blood and bone marrow before and during the study will also be monitored.', 'detailedDescription': 'Rituximab is a monoclonal antibody that is designed to attach to leukemia cells and activate a series of events that may cause the cancer cells to die.\n\nFludarabine is designed to make cancer cells less able to repair damaged DNA (the genetic material of cells). This may increase the likelihood of the cells dying.\n\nMitoxantrone is designed to stop cancer cells from making DNA, which may stop the cells from making more cells.\n\nDexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to MM patients in combination with other chemotherapy to treat cancer.\n\nStudy Groups:\n\nIf you are found eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. Each group will receive 8 "cycles" of treatment. One (1) cycle will last 28 days.\n\nGroup 1:\n\nIf you are in Group 1, you will receive the following drugs at the following times. Each study cycle is 28 days:\n\n* Rituximab will be given through a needle in the vein over about 90 minutes on Days 1 and 8 of the first course Cycle 1, and on Day 1 only of Cycles 2-5 of Fludarabine/ Mitoxantrone/ Dexamethasone (FND) treatment.\n* Fludarabine will be given through a needle in the vein over about 15 minutes on Days 2-4 of each cycle.\n* Mitoxantrone will be given through a needle in the vein over about 15 minutes on Day 2 of each cycle.\n* You will take dexamethasone by mouth with water on Days 1-5 of each 28-day cycle (FND).\n\nIf you miss any doses of the study drugs, please contact the research staff for instructions.\n\nYou will not receive rituximab in Cycles 6-8. When the 8 cycles are finished, you will begin receiving the drug interferon on Days 1-14 each month for 1 year. Dexamethasone will be given on Days 1-3 every month for 1 year.\n\nPatients in group 2 will receive fludarabine on Days 1-3, mitoxantrone on Day 1, and dexamethasone on Days 1-5 of each 28-day cycle. When 8 cycles of treatment are finished, patients will begin receiving the drug interferon on Days 1-14 each month for 1 year. Dexamethasone will be given on Days 1-3 every month for 1 year. About 4 months after interferon treatment starts, patients in group 2 will begin receiving rituximab once a month for 6 months.\n\nOther drugs may be given to help decrease the risk of or ease side effects. Treatment may be delayed or stopped if side effects are severe.\n\nMost of the drugs are given by vein. A catheter (a tube) will be placed in a vein to decrease the number of needle sticks. Dexamethasone may be taken by mouth instead of given by vein.\n\nSome patients in this study, with changes in certain genes will receive different chemotherapy drugs than other patients in the study will. The patients will, like all the other patients, receive rituximab and interferon. But instead of the FND chemotherapy regimen, they will receive a sequence of three regimens, CHOD-Bleo, ESHAP, and NOPP. The drugs in these regimens include: cyclophosphamide, doxorubicin, vincristine, bleomycin, VP-16, Ara-C, cisplatin, mitoxantrone, procarbazine, and corticosteroids (prednisone, methylprednisolone, dexamethasone).\n\nDuring the study, patients will have blood tests every week. Complete exams will be given in Cycles 2 and 4; patients will return to the clinic for these. Every 2 or 3 cycles, patients will have a chest x-ray and CT scans of the abdomen and pelvis. Bone marrow samples will be taken. Heart function tests (EKG) will be done as needed.\n\nAfter the study ends, patients will return for checkups every 3 months in the first year, every 4 months in years 2 and 3, and every 6 months in years 4 and 5. After that, checkups will be needed once a year. Blood and bone marrow samples will be taken at these visits.\n\nThis is an investigational study. Rituximab is approved by FDA for commercial use. The other drugs used in the study are also approved for commercial use. About 210 patients will take part in the study. All will be enrolled at University of Texas MD Anderson Cancer Center (UTMDACC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Previously untreated stage IV indolent B-cell lymphoma \\[Amendment May 2001: eligibility restricted to follicular lymphoma\\]\n2. Age \\<76\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT00577993', 'briefTitle': 'Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) for Stage IV Indolent Lymphoma', 'orgStudyIdInfo': {'id': 'DM97-261'}, 'secondaryIdInfos': [{'id': 'NCI-2010-01566', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1: FND + Rituximab Followed by Interferon', 'description': 'Fludarabine/Novantrone/Decadron + Rituximab Followed by Interferon', 'interventionNames': ['Drug: Fludarabine', 'Drug: Novantrone', 'Drug: Decadron', 'Drug: Rituximab', 'Drug: Interferon']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2: FND Followed by Interferon & Rituximab', 'description': 'Fludarabine/Novantrone/Decadron Followed by Interferon \\& Rituximab', 'interventionNames': ['Drug: Fludarabine', 'Drug: Novantrone', 'Drug: Decadron', 'Drug: Rituximab', 'Drug: Interferon']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon', 'description': 'Cyclophosphamide/Vincristine/Doxorubicin/Bleomycin (1st Sequence) + Rituximab; Etoposide/Cisplatin/Ara-C/Methyl-Prednisol (2nd Sequence); Novantrone/Vincristine/Procarbazine/Prednisone + Rituximab (3rd Sequence) Followed by Interferon', 'interventionNames': ['Drug: Novantrone', 'Drug: Decadron', 'Drug: Rituximab', 'Drug: Interferon', 'Drug: Doxorubicin', 'Drug: Vincristine', 'Drug: Bleomycin', 'Drug: Cyclophosphamide', 'Drug: Etoposide', 'Drug: Cisplatin', 'Drug: Ara-C', 'Drug: Methyl-Prednisolone', 'Drug: Procarbazine', 'Drug: Prednisone']}], 'interventions': [{'name': 'Fludarabine', 'type': 'DRUG', 'otherNames': ['2-fluoro-Ara Amp'], 'description': 'Group 1= 25 mg/m\\^2 IV over 15 min. Days 2 through 4 for 8 Cycles; Group 2 = 25 mg/m\\^2 IV over 15 min. Days 1 through 3 for 8 Cycles.', 'armGroupLabels': ['1: FND + Rituximab Followed by Interferon', '2: FND Followed by Interferon & Rituximab']}, {'name': 'Novantrone', 'type': 'DRUG', 'otherNames': ['Mitoxantrone'], 'description': 'Group 1 = 10 mg/m\\^2 IV over 15 min. Day 2 for 8 Cycles; Group 2 = 10 mg/m\\^2 IV over 15 min. Day 1 for 8 Cycles; Group 3 = 10 mg/m\\^2 IV over 15 min. Day 2 of 3rd Sequence.', 'armGroupLabels': ['1: FND + Rituximab Followed by Interferon', '2: FND Followed by Interferon & Rituximab', '3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Decadron', 'type': 'DRUG', 'otherNames': ['Dexamethasone'], 'description': 'Group 1 = 20 mg IV over 15 min. Days 1 through 5 for 8 Cycles, then Days 1 through 3 Every Month for 1 Year; Group 2 = 20 mg IV over 15 min. Days 1 through 5 for 8 Cycles, then Days 1 through 3 Every Month for 1 Year; Group 3 = 40 mg PO Days 1 through 4 of 1st Sequence; After Completion of 3 Sequences, Days 1 through 3 Every Month for 1 Year.', 'armGroupLabels': ['1: FND + Rituximab Followed by Interferon', '2: FND Followed by Interferon & Rituximab', '3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Chimeric Anti-CD20 Antibody', 'Anti-CD20', 'IDEC-C2B8'], 'description': 'Group 1 = 375 mg/m\\^2 IV Days 1 through 8 of Course 1, then Day 1 Only of Cycles 2 through 5; Group 2 = 4 Months after IFN Starts, 375 mg/m\\^2 IV Once Per Month for 6 Months; Group 3 = 375 mg/m\\^2 IV Days 1 through 8 of 1st Sequence; 375 mg/m\\^2 IV Days 1 through 8 of 3rd Sequence.', 'armGroupLabels': ['1: FND + Rituximab Followed by Interferon', '2: FND Followed by Interferon & Rituximab', '3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Interferon', 'type': 'DRUG', 'otherNames': ['Interferon Alpha-2b', 'IFN'], 'description': 'Group 1 = After Completion of Fludarabine, Novantrone, \\& Rituximab, IFN 3 mcg/ml/m\\^2 SQ Days 1 through 14 Each Month for 1 year; Group 2 = After Completion of Fludarabine \\& Novantrone, IFN 3 mcg/ml/m\\^2 SQ Days 1 through 14 Each Month for 1 year; Group 3 = After Completion of 3 Sequences, IFN 3 mcg/ml/m\\^2 SQ Days 1 through 14 Each Month for 1 year.', 'armGroupLabels': ['1: FND + Rituximab Followed by Interferon', '2: FND Followed by Interferon & Rituximab', '3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': '25 mg/m\\^2 IV Days 2 \\& 3 of 1st Sequence.', 'armGroupLabels': ['3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': '.7 mg/m\\^2 IV Days 2 \\& 3 of 1st Sequence; 1.4 mg/m\\^2 IV Day 2 of 3rd Sequence.', 'armGroupLabels': ['3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Bleomycin', 'type': 'DRUG', 'description': '5 unit/m\\^2 IV Days 2 \\& 3 of 1st Sequence.', 'armGroupLabels': ['3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '750 mg/m\\^2 IV Day 2 of 1st Sequence.', 'armGroupLabels': ['3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': '40 mg/m\\^2 IV Days 1 through 4 of 2nd Sequence.', 'armGroupLabels': ['3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '25 mg/m\\^2 IV Days 1 through 4 of 2nd Sequence', 'armGroupLabels': ['3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Ara-C', 'type': 'DRUG', 'description': '1.5 gm/m\\^2 IV Day 5 of 2nd Sequence.', 'armGroupLabels': ['3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Methyl-Prednisolone', 'type': 'DRUG', 'description': '500 mg IV Days 1 through 5 of 2nd Sequence.', 'armGroupLabels': ['3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Procarbazine', 'type': 'DRUG', 'description': '100 mg/m\\^2 PO Days 2 through 11 of 3rd Sequence.', 'armGroupLabels': ['3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': '100 mg PO Days 1 through 5 of 3rd Sequence.', 'armGroupLabels': ['3: CHOD-Bleo, ESHAP, NOPP + Rituximab Followed by Interferon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Nathan Fowler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}