A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00738374
First received: August 18, 2008
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
This single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previously untreated chronic lymphocytic leukemia. During the induction phase patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses of MabThera given every 8 weeks, or no further treatment. The anticipated time on study treatment is 2+ years, and the target sample size is <100 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphocytic Leukemia, Chronic |
Drug: rituximab [MabThera/Rituxan] Drug: chlorambucil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of Chlorambucil Plus MabThera as Induction Therapy Followed in Responders by Maintenance Therapy Versus Observation on Response Rate in Patients >=60 Years With Previously Untreated Chronic Lymphocytic Leukemia |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Overall tumor response at end of induction phase [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Complete response, partial response at end of induction phase [ Time Frame: 10 months ] [ Designated as safety issue: No ]
- Overall tumor response, complete response, partial response at end of maintenance phase [ Time Frame: 35 months ] [ Designated as safety issue: No ]
- Event-free survival, progression-free survival, duration of response, disease-free survival, overall survival, time to new treatment or death. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- AEs, laboratory parameters, ECG, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 97 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv on day 1 of course 3; 500mg/m2 iv on day 1 of courses 4-8 (induction phase); 375mg/m2 iv every 8 weeks (maintenance phase).
Drug: chlorambucil
8mg/m2 po on days 1-7 of courses 1-8
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients, >=60 years of age;
- CD20+ chronic lymphocytic leukemia (CLL);
- no previous treatment for CLL;
- ECOG performance status 0-1.
Exclusion Criteria:
- co-morbid conditions requiring long term use of systemic corticosteroids during study treatment;
- history of severe cardiac disease;
- transformation to aggressive B-cell malignancy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738374
Locations
| Italy | |
| Bari, Italy, 70124 | |
| Bologna, Italy, 40138 | |
| Catania, Italy, 95124 | |
| Catanzaro, Italy, 88100 | |
| Cosenza, Italy, 87100 | |
| Ferrara, Italy, 44100 | |
| Firenze, Italy, 50135 | |
| Genova, Italy, 16132 | |
| Messina, Italy, 98165 | |
| Milano, Italy, 20122 | |
| Milano, Italy, 20162 | |
| Napoli, Italy, 80131 | |
| Padova, Italy, 35128 | |
| Reggio Calabria, Italy, 89100 | |
| Roma, Italy, 00161 | |
| Roma, Italy, 00144 | |
| Siena, Italy, 53100 | |
| Torino, Italy, 10126 | |
| Verona, Italy, 37134 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00738374 History of Changes |
| Other Study ID Numbers: | ML21445, 2008-001612-20 |
| Study First Received: | August 18, 2008 |
| Last Updated: | May 13, 2013 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Chronic Disease Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Attributes |
Pathologic Processes Chlorambucil Rituximab Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013