Clinical Trials Logo

Clinical Trial Summary

This study will assess the effect of maintenance treatment with rituximab in comparison with observation period (no treatment), in participants with progressive B-cell CLL who have had previous first-line induction treatment with rituximab, cladribine and cyclophosphamide (RCC regimen). After 6 months of RCC induction therapy, participants will be randomized either to receive maintenance treatment with rituximab or to receive no treatment (observation only) for 96 weeks. Participants completing maintenance/observation period will be followed-up for approximately 3 years.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT00718549
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 3
Start date July 21, 2009
Completion date September 14, 2015

See also
  Status Clinical Trial Phase
Completed NCT01072240 - An Observational Study on Infusion-related Adverse Events at Administration of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia N/A
Completed NCT00754650 - A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia Phase 2
Active, not recruiting NCT02500407 - A Safety, Efficacy and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) Phase 1/Phase 2
Recruiting NCT04704323 - CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia
Active, not recruiting NCT01414205 - A Study Comparing RO5072759 (GA101) 1000 mg Versus 2000 mg in Patients With Previously Untreated Chronic Lymphocytic Leukemia (GAGE) Phase 2
Completed NCT01224093 - 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) N/A
Completed NCT01395615 - An Observational Study on The Health Related Quality of Life in Patients With Chronic Lymphocytic Leukaemia N/A
Completed NCT00532129 - A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Chronic Lymphocytic Leukemia. Phase 2
Completed NCT02013817 - CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy Phase 2
Completed NCT01685892 - A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia Phase 1
Completed NCT00738374 - A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia. Phase 2
Completed NCT00241358 - Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies Phase 1/Phase 2
Completed NCT01056510 - A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe) Phase 4
Completed NCT01300247 - A Study of GA101 (RO5072759) in Combination With Chemotherapy in Patients With Previously Untreated Chronic Lymphocytic Leukemia (GALTON) Phase 1
Terminated NCT01271010 - A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status Phase 4
Completed NCT01263704 - A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia Phase 2
Completed NCT00431873 - A Phase II Study of MGCD0103 (MG-0103) in Patients With Refractory Chronic Lymphocytic Leukemia Phase 2
Completed NCT01178086 - A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
Terminated NCT02292225 - Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY) Phase 1
Completed NCT02533401 - A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL) Phase 2