Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-27 @ 12:17 AM
Study NCT ID:
NCT00391066
Status:
TERMINATED
Last Update Posted:
2015-10-02
First Post:
2006-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumiliximab With Fludarabine, Cyclophosphamide, and Rituximab (FCR) Versus FCR Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011961', 'term': 'Receptors, Fc'}, {'id': 'C509683', 'term': 'lumiliximab'}], 'ancestors': [{'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 627}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'dispFirstSubmitDate': '2015-09-17', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-17', 'studyFirstSubmitDate': '2006-10-19', 'dispFirstSubmitQcDate': '2015-09-17', 'studyFirstSubmitQcDate': '2006-10-19', 'dispFirstPostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response (CR) rate', 'timeFrame': 'Every 3 months until all patients have reached at least week 33'}], 'secondaryOutcomes': [{'measure': 'Time to event variables (progression free survival, duration of response, time to next therapy, time to progression and overall survival)', 'timeFrame': 'Every 3 months until all patients have reached at least week 33'}, {'measure': 'Response variables', 'timeFrame': 'Every 3 months until all patients have reached at least week 33'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CD23+/CD20+ B-cell CLL', 'CLL'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'pmid': '19843887', 'type': 'BACKGROUND', 'citation': "Byrd JC, Kipps TJ, Flinn IW, Castro J, Lin TS, Wierda W, Heerema N, Woodworth J, Hughes S, Tangri S, Harris S, Wynne D, Molina A, Leigh B, O'Brien S. Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. Blood. 2010 Jan 21;115(3):489-95. doi: 10.1182/blood-2009-08-237727. Epub 2009 Oct 20."}, {'pmid': '18032710', 'type': 'BACKGROUND', 'citation': 'Pathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. doi: 10.1182/blood-2007-03-082024. Epub 2007 Nov 21.'}, {'pmid': '17671129', 'type': 'BACKGROUND', 'citation': "Byrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55. doi: 10.1158/1078-0432.CCR-06-1463."}, {'pmid': '25130401', 'type': 'DERIVED', 'citation': 'Awan FT, Hillmen P, Hellmann A, Robak T, Hughes SG, Trone D, Shannon M, Flinn IW, Byrd JC; LUCID trial investigators. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia. Br J Haematol. 2014 Nov;167(4):466-77. doi: 10.1111/bjh.13061. Epub 2014 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab in combination with FCR or FCR alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed, written EC-approved informed consent form.\n* Diagnosis of relapsed CD23+ and CD20+ B cell CLL as defined by NCI WG guidelines.\n* Subjects who have received at least 1 but no more than 2 prior single agent or combination treatments for CLL.\n* Rai Stage III or IV (Binet Stage C), or Rai Stage I or II (Binet Stage A or B) if determined to have disease progression as evidenced by rapid doubling of peripheral lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms (Staging Criteria - Modified Rai).\n* WHO Performance Status less than or equal to 2.\n* Age greater than or equal to 18 years.\n* Male and female subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment.\n* Acceptable liver function: bilirubin less than or equal to 2.0 mg/dL (26 µmol/L); AST and ALT less than or equal to 2 times upper limit of normal.\n* Acceptable hematologic status: platelet count greater than or equal to 50 x 10\\^9/L should be unsupported by transfusion; ANC greater than or equal to 1 x 10\\^9/L.\n* Acceptable renal function: creatinine clearance calculated according to the formula of Cockcroft and Gault \\>50 mL/min; serum creatinine less than or equal to 1.5 times upper limit of normal.\n\nExclusion Criteria:\n\n* Subjects who are refractory to the following combination therapies: purine analogue + R, purine analogue + C, or purine analogue + CR. Refractory is defined as not achieving at least a PR for a minimum duration of 6 months as determined by treating physician. Purine analogues include fludarabine, pentostatin and cladribine.\n* Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other investigational therapy within 4 weeks prior to Study Day 1.\n* Previous exposure to lumiliximab or other anti-CD23 antibodies.\n* Prior autologous or allogeneic BMT or hematopoetic stem cell transplant.\n* Known infection with HIV, hepatitis B, or hepatitis C. Although testing for hepatitis B or hepatitis C is not mandatory, this should be considered for all subjects considered at high risk of hepatitis B or hepatitis C infection and in endemic areas. Subjects with any serological evidence of current or past hepatitis B or hepatitis C exposure are excluded unless the serological findings are clearly due to vaccination.\n* Uncontrolled diabetes mellitus.\n* Uncontrolled hypertension.\n* Transformation to aggressive B-cell malignancy (e.g., large B cell lymphoma, Richter's Syndrome, or PLL).\n* Secondary malignancy requiring active treatment (except hormonal therapy).\n* Any medical condition that would require long-term use (\\>1 month) of systemic corticosteroids during study treatment. However, steroid use less than or equal to 1 month is permissible during the study.\n* Any serious nonmalignant disease or laboratory abnormality, which in the opinion of the Investigator and/or Sponsor would compromise protocol objectives.\n* Active uncontrolled bacterial, viral, or fungal infections.\n* New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Study Day 1, unstable arrhythmia, or evidence of ischemia on ECG within 30 days prior to Study Day 1.\n* Seizure disorders requiring anticonvulsant therapy.\n* Severe chronic obstructive pulmonary disease with hypoxemia.\n* Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1.\n* Clinically active autoimmune disease.\n* History of fludarabine-induced autoimmune cytopenia (as judged by the Investigator) or Coombs-positive haemolytic anemia.\n* Pregnant or currently breastfeeding."}, 'identificationModule': {'nctId': 'NCT00391066', 'acronym': 'LUCID', 'briefTitle': 'Lumiliximab With Fludarabine, Cyclophosphamide, and Rituximab (FCR) Versus FCR Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': '152CL201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'FCR\n\nF (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks\n\nC (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks\n\nR: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks', 'interventionNames': ['Drug: FCR']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'FCR + Lumiliximab (L)\n\nL (Lumiliximab): Day 2 50 mg/m2, Day 4 450 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks.\n\nF (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks\n\nC (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks\n\nR: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks', 'interventionNames': ['Drug: FCR + Lumiliximab']}], 'interventions': [{'name': 'FCR + Lumiliximab', 'type': 'DRUG', 'description': 'Dose, schedule, and duration specified in the protocol', 'armGroupLabels': ['2']}, {'name': 'FCR', 'type': 'DRUG', 'description': 'Dose, schedule, and duration specified in protocol', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': 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