Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT01099202
Status:
COMPLETED
Last Update Posted:
2012-08-27
First Post:
2010-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Procrit Versus No Procrit in Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068817', 'term': 'Epoetin Alfa'}, {'id': 'D004921', 'term': 'Erythropoietin'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eharriso@mdanderson.org', 'phone': '713/794-5783', 'title': 'Jorge Cortes M.D./Professor', 'organization': 'The University of Texas M. D. Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 years, 2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Procrit', 'description': 'Starting dose 40,000 Units subcutaneously once a week with chemotherapy.', 'otherNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'No Procrit', 'description': 'No intervention.', 'otherNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'seriousNumAffected': 6}], 'seriousEvents': [{'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Number of RBC Units Transfused During Initial 5 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Procrit', 'description': 'Procrit starting dose 40,000 Units subcutaneously once a week with chemotherapy.'}, {'id': 'OG001', 'title': 'No Procrit', 'description': 'No intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.63', 'spread': '6.29', 'groupId': 'OG000'}, {'value': '13.11', 'spread': '5.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks to 5 Months', 'description': 'Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets.', 'unitOfMeasure': 'PRBC Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.'}, {'type': 'PRIMARY', 'title': 'Number of PRBC Transfusions During Initial 5 Months of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Procrit', 'description': 'Starting dose 40,000 Units subcutaneously once a week with chemotherapy.'}, {'id': 'OG001', 'title': 'No Procrit', 'description': 'No intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.22', 'spread': '3.87', 'groupId': 'OG000'}, {'value': '7.44', 'spread': '3.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks to 5 Months', 'description': 'Total number of all packed red blood cells (PRBCs) transfusions (events) given to a participant throughout the 6 courses of chemotherapy treatment, collected and reported by participant from fifth week beginning baseline to 5 months.', 'unitOfMeasure': 'transfusions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Procrit', 'description': 'Starting dose 40,000 Units subcutaneously once a week with chemotherapy.'}, {'id': 'FG001', 'title': 'No Procrit', 'description': 'No intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment Period 3/11/2003 - 5/25/2011; all patients were registered at The University of Texas M.D. Anderson Cancer Center.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Procrit', 'description': 'Starting dose 40,000 Units subcutaneously once a week with chemotherapy.'}, {'id': 'BG001', 'title': 'No Procrit', 'description': 'No intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '76'}, {'value': '42', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '84'}, {'value': '41', 'groupId': 'BG002', 'lowerLimit': '15', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-24', 'studyFirstSubmitDate': '2010-04-05', 'resultsFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2010-04-05', 'lastUpdatePostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-24', 'studyFirstPostDateStruct': {'date': '2010-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Number of RBC Units Transfused During Initial 5 Months of Treatment', 'timeFrame': '5 weeks to 5 Months', 'description': 'Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets.'}, {'measure': 'Number of PRBC Transfusions During Initial 5 Months of Treatment', 'timeFrame': '5 weeks to 5 Months', 'description': 'Total number of all packed red blood cells (PRBCs) transfusions (events) given to a participant throughout the 6 courses of chemotherapy treatment, collected and reported by participant from fifth week beginning baseline to 5 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Procrit', 'Acute Lymphocytic Leukemia', 'Lymphoblastic Lymphoma', "Burkitt's", 'Chemotherapy', 'Hyper-CVAD', 'augmented BFM', 'Epoetin alfa', 'Epogen', 'Erythropoietin'], 'conditions': ['Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical research study is to learn if Procrit (epoetin alfa) will decrease the need for blood transfusions in patients with Acute Lymphocytic Leukemia (ALL), Lymphoblastic Lymphoma (LL), or Burkitt's who are receiving chemotherapy. Another goal is to study the remission rates in patients with cancer who have received treatment with epoetin alfa.", 'detailedDescription': 'Epoetin alfa is a medication that helps the body make more red blood cells.\n\nBefore treatment you will have a complete physical exam. You will have around 1 tablespoon of blood drawn for blood tests (these tests are in addition to the routine blood tests you will have as part of your standard of care). Women who are able to have children must have a negative blood pregnancy test.\n\nYou will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Patients in the first group will be given epoetin alfa once a week at the time chemotherapy is started. Patients in the other group will not receive epoetin alfa, but will undergo the same laboratory exams and quality of life evaluations as the group of patients who were given epoetin alfa.\n\nPatients in both groups will receive transfusions if their hemoglobin drops below a certain level or it the doctor feels it is necessary. These transfusions are considered to be standard of care. You will be asked to keep a diary listing the dates of all transfusions you receive.\n\nIf you are assigned to receive epoetin alfa, you will be given epoetin alfa once a week during your regularly scheduled chemotherapy. You will receive treatment with epoetin alfa for up to 6 courses of chemotherapy (usually around 5 months, but may be longer). Epoetin alfa will be given to you as an injection under the skin. Once a week, you will have around 1 tablespoon of blood drawn to check the level of hemoglobin in your blood. If your hemoglobin rises above a certain level, treatment with epoetin alfa may be temporarily stopped until your hemoglobin level decreases.\n\nPatients in both groups will continue to receive chemotherapy during this study as scheduled. During chemotherapy, you will have around 1 tablespoon of blood drawn every 1-2 weeks for routine blood tests (as part of your standard of care for treatment of cancer).\n\nIf you agree to the optional procedures, you will continue receiving epoetin alfa even if your hemoglobin levels show that you are not responding to epoetin alfa treatment. However, if you do not choose to take part in the optional procedures and you are not responding to epoetin alfa treatment, you will be taken off the study.\n\nIf you experience any intolerable side effects that are a result of epoetin alfa or your disease gets worse, you will be taken off the study.\n\nThis is an investigational study. Epoetin alfa is FDA approved and commercially available. Around 164 patients will take part in this study. All will be enrolled at M. D. Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with a diagnosis of ALL, LL, or Burkitt's receiving induction chemotherapy with Hyper-CVAD, any variant of Hyper-CVAD or augmented BFM at MD Anderson Cancer Center.\n2. Patients must be enrolled on the study + / - (plus or minus) 14 days from the start of induction chemotherapy.\n3. Patients with relapsed ALL, LL, or Burkitt's are eligible, but must have had a remission duration of 1 year or longer.\n\nExclusion Criteria:\n\n1. Hemoglobin greater than or equal to 10 g/dL.\n2. Patients with prior treatment with epoetin alfa or any investigational forms of erythropoietin within the previous 3 months.\n3. Patients with known hypersensitivity to mammalian-cell derived products or to human albumin.\n4. Uncontrolled hypertension\n5. History of thrombotic vascular event.\n6. Pregnant or lactating women.\n7. Anemia due to factors other than cancer, deficiencies of B12, folate, or iron (only with concurrent treatment of these deficiencies)."}, 'identificationModule': {'nctId': 'NCT01099202', 'briefTitle': "Procrit Versus No Procrit in Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy", 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': "A Randomized Study of Procrit Versus No Procrit in Patients With Acute Lymphocytic Leukemia, Lymphoblastic Lymphoma, or Burkitt's Undergoing Induction/Consolidation Chemotherapy", 'orgStudyIdInfo': {'id': 'ID02-591'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Procrit', 'description': 'Starting dose 40,000 units subcutaneously once a week with chemotherapy.', 'interventionNames': ['Drug: Procrit (epoetin alfa)']}, {'type': 'NO_INTERVENTION', 'label': 'No Procrit', 'description': 'No intervention.'}], 'interventions': [{'name': 'Procrit (epoetin alfa)', 'type': 'DRUG', 'otherNames': ['epoetin alfa', 'Epogen', 'Erythropoietin'], 'description': 'Starting dose 40,000 Units subcutaneously once a week during your regularly scheduled chemotherapy for up to 6 courses of chemotherapy (around 5 months).', 'armGroupLabels': ['Procrit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jorge Cortes, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UT MD Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}