Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT00637832
Status:
TERMINATED
Last Update Posted:
2022-01-06
First Post:
2008-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000069283', 'term': 'Rituximab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'C422802', 'term': 'ibritumomab tiuxetan'}], 'ancestors': [{'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': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'no information', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2015-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-16', 'studyFirstSubmitDate': '2008-03-14', 'studyFirstSubmitQcDate': '2008-03-14', 'lastUpdatePostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate, including combined complete response and partial response'}], 'secondaryOutcomes': [{'measure': 'Time to disease progression'}, {'measure': 'Time to next treatment'}, {'measure': 'Response duration in patients with responding disease'}, {'measure': 'Safety'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recurrent grade 1 follicular lymphoma', 'recurrent grade 2 follicular lymphoma', 'recurrent grade 3 follicular lymphoma', 'contiguous stage II grade 1 follicular lymphoma', 'contiguous stage II grade 2 follicular lymphoma', 'contiguous stage II grade 3 follicular lymphoma', 'noncontiguous stage II grade 1 follicular lymphoma', 'noncontiguous stage II grade 2 follicular lymphoma', 'noncontiguous stage II grade 3 follicular lymphoma', 'stage III grade 1 follicular lymphoma', 'stage III grade 2 follicular lymphoma', 'stage III grade 3 follicular lymphoma', 'stage IV grade 1 follicular lymphoma', 'stage IV grade 2 follicular lymphoma', 'stage IV grade 3 follicular lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '26849853', 'type': 'DERIVED', 'citation': 'Illidge TM, McKenzie HS, Mayes S, Bates A, Davies AJ, Pettengell R, Stanton L, Cozens K, Hampson G, Dive C, Zivanovic M, Tipping J, Gallop-Evans E, Radford JA, Johnson PW. Short duration immunochemotherapy followed by radioimmunotherapy consolidation is effective and well tolerated in relapsed follicular lymphoma: 5-year results from a UK National Cancer Research Institute Lymphoma Group study. Br J Haematol. 2016 Apr;173(2):274-82. doi: 10.1111/bjh.13954. Epub 2016 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving rituximab together with combination chemotherapy and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.\n\nPURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed follicular non-Hodgkin lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To evaluate the response rates in patients with relapsed follicular non-Hodgkin lymphoma treated with short-duration rituximab and combination chemotherapy (R-chemo) followed by rituximab and yttrium Y 90 ibritumomab tiuxetan.\n\nSecondary\n\n* To evaluate the duration of response in patients treated with this regimen.\n* To evaluate the quality of response in order to determine the conversion rate from partial response to complete response in patients treated with this regimen.\n* To evaluate the toxicity of yttrium Y 90 ibritumomab tiuxetan when administered after 3 courses of R-chemo.\n\nOUTLINE: This is a multicenter study.\n\n* Chemoimmunotherapy (R-CHOP or R-CVP): Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Alternatively, patients who have already been exposed to prior tolerance doses of anthracyclines receive R-CVP comprising rituximab IV, cyclophosphamide IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment repeats every 3 weeks for up to 3 courses.\n\nPatients with objective evidence of response on CT scan or those with \\< 25% bone marrow involvement and no signs of bone marrow hypocellularity (\\< 15%) on bone marrow biopsy proceed to radioimmunotherapy.\n\n* Radioimmunotherapy: Four to 6 weeks after completion of R-CHOP or R-CVP, patients receive rituximab IV followed no more than 4 hours later by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes.\n\nAfter completion of study therapy, patients are followed periodically for up to 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed grade 1, 2, or 3 follicular non-Hodgkin lymphoma\n\n * Stage II, III, or IV disease (according to the Ann Arbor staging system)\n* CD20-positive disease\n* Initial disease bulk ≤ 10 cm\n* In first or second relapse after prior treatment with a rituximab-containing chemotherapy regimen (R-chemo) or chemotherapy alone\n\n * Relapse must have occurred ≥ 6 months after completion of R-chemo\n\n * Relapse that occurred \\< 6 months after completion of chemotherapy alone allowed\n* Has at least one of the following symptoms requiring initiation of treatment:\n\n * Nodal mass \\> 5 cm in its greater diameter\n * B symptoms\n * Elevated serum lactate dehydrogenase (LDH) or β2-microglobulin\n * Involvement of ≥ 3 nodal sites (each with a diameter \\> 3 cm)\n * Symptomatic splenic enlargement\n * Compressive syndrome\n* No primary refractory disease\n* No large pleural or peritoneal effusions\n* No CNS disease\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Life expectancy ≥ 6 months\n* Absolute granulocyte count ≥ 1,500/mm³\n* Platelet count ≥ 1,000/mm³\n* Serum creatinine \\< 1.5 times upper limit of normal (ULN)\n* Total bilirubin \\< 1.5 times ULN\n* AST \\< 5 times ULN\n* No active obstructive hydronephrosis\n* No evidence of active infection requiring IV antibiotics\n* No advanced heart disease or other serious illness that would preclude study evaluation\n* No known HIV infection\n* No human anti-mouse antibody (HAMA) reactivity\n* No known hypersensitivity to murine antibodies or proteins\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 12 months after completion of study treatment\n* No other prior malignancy, except for adequately treated skin cancer, cervical cancer in situ, or other cancer for which the patient has been disease-free for 5 years\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* At least 4 weeks since prior investigational drugs and recovered\n* No prior radioimmunotherapy'}, 'identificationModule': {'nctId': 'NCT00637832', 'briefTitle': 'Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Southampton'}, 'officialTitle': 'Short Chemo Radiotherapy in Follicular Lymphoma Trial of 90Y Ibritumomab Tiuxetan (ZevalinTM) as Therapy for First and Second Relapse in Follicular Lymphoma', 'orgStudyIdInfo': {'id': 'CDR0000588042'}, 'secondaryIdInfos': [{'id': 'USCTU-SCHRIFT-06-DOG05-44', 'type': 'OTHER', 'domain': 'USCTU'}, {'id': 'USCTU-RHM-CAN0542', 'type': 'OTHER', 'domain': 'USCTU-RHM'}, {'id': '2007-000222-51', 'type': 'EUDRACT_NUMBER'}, {'id': 'EU-20819', 'type': 'OTHER', 'domain': 'EU'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single group', 'interventionNames': ['Biological: rituximab', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: prednisolone', 'Drug: vincristine sulfate', 'Radiation: yttrium Y 90 ibritumomab tiuxetan']}], 'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL', 'armGroupLabels': ['single group']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['single group']}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['single group']}, {'name': 'prednisolone', 'type': 'DRUG', 'armGroupLabels': ['single group']}, {'name': 'vincristine sulfate', 'type': 'DRUG', 'armGroupLabels': ['single group']}, {'name': 'yttrium Y 90 ibritumomab tiuxetan', 'type': 'RADIATION', 'armGroupLabels': ['single group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'HA6 2RN', 'city': 'Northwood', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Mount Vernon Cancer Centre at Mount Vernon Hospital', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'zip': 'BH15 2JB', 'city': 'Poole Dorset', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Dorset Cancer Centre'}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'EC1A 7BE', 'city': 'London', 'country': 'United Kingdom', 'facility': "Saint Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Tim Illidge', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Christie NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southampton', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}