A Study of MabThera (Rituximab) in First Line Treatment of 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:
NCT00545714
First received: October 16, 2007
Last updated: October 10, 2012
Last verified: October 2012
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Purpose
This single arm study will assess the efficacy and safety of MabThera in combination with fludarabine and cyclophosphamide, followed by MabThera maintenance therapy, as first line treatment of patients with chronic lymphocytic leukemia. Patients will receive 6 cycles of treatment with MabThera (375mg/m2 i.v. on day 1 of cycle 1, and 500mg/m2 i.v. on day 1 of cycles 2-6), fludarabine (25mg/m2 on days 1-3) and cyclophosphamide (250mg/m2 on days 1-3). Patients with a partial or complete response will receive maintenance treatment with MabThera (375mg/m2 i.v. every 2 months). 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: Fludarabine Drug: Cyclophosphamide |
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: | An Open Label Study to Assess the Effect of First Line Treatment With MabThera in Combination With Fludarabine and Cyclophosphamide, Followed by MabThera Monotherapy, on Response Rate in Patients With Chronic Lymphocytic Leukemia. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Response rate, and percentage of patients with molecular remission [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PFS, overall survival, treatment-free survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 90 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv on day 1 of cycle 1; 500mg/m2 iv on day 1 of cycles 2-6
Drug: Fludarabine
25mg/m2 on days 1-3
Drug: Cyclophosphamide
250mg/m2 iv on days 1-3
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients, 18-70 years of age;
- CD20-positive B-cell chronic lymphocytic leukemia;
- active disease;
- no previous treatment.
Exclusion Criteria:
- transformation to aggressive B-cell malignancy;
- history of other malignancies except for localised skin cancer;
- continuous systemic corticosteroid treatment;
- known infection with hepatitis B or C.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545714
Locations
| Spain | |
| Alcala de Henares, Spain, 28805 | |
| Alcorcon, Spain, 28922 | |
| Badajoz, Spain, 06080 | |
| Bilbao, Spain, 48013 | |
| Caceres, Spain, 10003 | |
| Castellon, Spain, 12004 | |
| Cádiz, Spain, 11009 | |
| Gandia, Spain, 46700 | |
| Granada, Spain, 18014 | |
| Hospitalet de Llobregat, Spain, 08907 | |
| Jerez de La Frontera, Spain, 11407 | |
| La Coruna, Spain, 15006 | |
| Madrid, Spain, 28905 | |
| Madrid, Spain, 28041 | |
| Madrid, Spain, 28034 | |
| Madrid, Spain, 28222 | |
| Madrid, Spain, 28050 | |
| Madrid, Spain, 28046 | |
| Madrid, Spain, 28040 | |
| Madrid, Spain, 28007 | |
| Malaga, Spain, 29010 | |
| Mostoles, Spain, 28935 | |
| Murcia, Spain, 30008 | |
| Sagunto, Spain, 46520 | |
| Salamanca, Spain, 37007 | |
| Santander, Spain, 39008 | |
| Valencia, Spain, 46015 | |
| Valencia, Spain, 46009 | |
| Valencia, Spain, 46017 | |
| Valencia, Spain, 46014 | |
| Vitoria, Spain, 01009 | |
| Zaragoza, Spain, 59009 | |
| Zaragoza, Spain, 50009 | |
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: | NCT00545714 History of Changes |
| Other Study ID Numbers: | ML21135 |
| Study First Received: | October 16, 2007 |
| Last Updated: | October 10, 2012 |
| Health Authority: | Spain: Agencia Espanola del Medicamento y Productos Sanitarios |
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 Cyclophosphamide Fludarabine monophosphate |
Rituximab Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on October 17, 2012
