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Lymphocytic Leukemia, Chronic clinical trials

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NCT ID: NCT01488162 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia

Start date: April 4, 2011
Phase: N/A
Study type: Observational

This multi-center, prospective, observational study will describe the management of relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2 years.

NCT ID: NCT01414205 Active, not recruiting - Clinical trials for Lymphocytic Leukemia, Chronic

A Study Comparing RO5072759 (GA101) 1000 mg Versus 2000 mg in Patients With Previously Untreated Chronic Lymphocytic Leukemia (GAGE)

Start date: October 2011
Phase: Phase 2
Study type: Interventional

This open-label, multicenter, randomized study will compare the efficacy, safety and pharmacokinetics of RO5072759 (GA101) 1000 mg versus 2000 mg in patients with previously untreated chronic lymphocytic leukemia. The randomization scheme will ensure approximately equal sample sizes in the two treatment dose arms for the following stratification factors: 1) tumor burden at baseline (high or low); and 2) Rai stage at baseline (study entry; I/II or III/IV). Tumor burden will be assessed on the basis of the presence or absence of at least one nodal mass >/= 5 cm in the baseline computed tomography (CT) scan. Patients will be randomized to receive a maximum of 8 cycles of GA101: 1000mg intravenous (iv) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8 on 21 day cycles or maximum of 8 cycles of GA101 2000mg iv infusion, on days 1 (split dose 100 mg on Day 1, 900 mg on Day 2, 1000 mg on Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8 on 21 day cycles.

NCT ID: NCT01395615 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

An Observational Study on The Health Related Quality of Life in Patients With Chronic Lymphocytic Leukaemia

Start date: October 2008
Phase: N/A
Study type: Observational

This observational study will assess the health related quality of life (HQRL) profiles of patients with chronic lymphocytic leukaemia. Using health assessment questionnaires, data will be collected from patients currently receiving therapy and from those who have finished therapy and have undergone an assessment of treatment.

NCT ID: NCT01300247 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

A Study of GA101 (RO5072759) in Combination With Chemotherapy in Patients With Previously Untreated Chronic Lymphocytic Leukemia (GALTON)

Start date: June 2011
Phase: Phase 1
Study type: Interventional

This open-label, 2-arm, nonrandomized, multicenter, Phase Ib study will investigate the safety and efficacy of RO5072759 (GA101) administered in combination with chemotherapy (bendamustine or FC regimens) in patients with previously untreated CD20-positive B-CLL. Patients will be enrolled to receive a maximum of 6 cycles of GA101 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2 - 6) plus bendamustine (90 mg/m2 IV, on days 2 and 3 of cycle 1 and days 1 and 2 of cycles 2 - 6) on 28 day cycles or a maximum of 6 cycles of GA101 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2 - 6) plus FC (fludarabine 25 mg/m2 IV on days 2, 3 and 4 of cycle 1 and days 1, 2 and 3 of cycles 2 - 6; cyclophosphamide 250 mg/m2 IV on days 2, 3 and 4 of cycle 1 and days 1, 2 and 3 of cycles 2 - 6) on 28 day cycles.

NCT ID: NCT01292603 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia

Start date: April 18, 2011
Phase: Phase 1
Study type: Interventional

This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.

NCT ID: NCT01283386 Terminated - Clinical trials for Lymphocytic Leukemia, Chronic

A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

Start date: April 27, 2011
Phase: Phase 4
Study type: Interventional

This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in participants with previously untreated B-cell chronic lymphocytic leukemia and unfavorable somatic status. Participants were randomized to receive Mabthera (375 mg/m2 intravenously [IV] Day 1 of Cycle 1, 500 mg/m2 IV Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 IV or 32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 IV or orally Days 1-3) or with chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study treatment was 24 weeks.

NCT ID: NCT01271010 Terminated - Clinical trials for Lymphocytic Leukemia, Chronic

A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status

Start date: June 17, 2011
Phase: Phase 4
Study type: Interventional

This multi-center, single-arm study evaluated the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide in participants with B-cell chronic lymphocytic leukemia (CLL) and favorable somatic status.

NCT ID: NCT01263704 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia

Start date: July 17, 2011
Phase: Phase 2
Study type: Interventional

This single arm, open-label study will assess the safety and efficacy of low dose fludarabine and cyclophosphamide in combination with standard dose MabThera/Rituxan (rituximab) as primary therapy in elderly patients (>/= 65 years) with chronic lymphocytic leukemia. Patients will receive six 28-day cycles of treatment with Mabthera/Rituxan (375 mg/m2 intravenously [iv] Day 0 of cycle 1, 500 mg/m2 iv Day 1 of cycles 2-6), fludarabine (12.5 mg/m2/d iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv Days 1-3, cycles 1-6). Anticipated time on study treatment is 6 months, with a 30-month follow-up period.

NCT ID: NCT01224093 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

An Observational Study on the Safety Profile of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (MABERYC)

Start date: October 2010
Phase: N/A
Study type: Observational

This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.

NCT ID: NCT01178086 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)

Start date: February 22, 2010
Phase:
Study type: Observational

This observational study will assess the therapeutic efficiency, treatment schedules, handling procedures, and the safety profile of rituximab in routine care in participants with CLL.