A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01144403
First received: June 14, 2010
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in patients with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Patients will receive MabThera (372 mg/m2 intravenously) on day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In patients experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles. Anticipated time on study treatment is 6 to 8 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, B-Cell |
Drug: rituximab [Mabthera/Rituxan] Drug: fludarabine Drug: cyclophosphamide Drug: mitoxantrone |
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 Phase II Multicenter Open-label Study of MabThera(Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Cyclophosphamide
Fludarabine
Mitoxantrone
Mitoxantrone hydrochloride
Fludarabine phosphate
Rituximab
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Overall Response Rate (ORR), according to International Working Group (IWG) criteria, assessed by computed tomography (CT) or magnetic resonance imaging (MRI) [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
- Progression-free survival, according to IWG criteria, assessed by CT or MRI [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
- Safety and tolerability: Adverse events. laboratory parameters [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
| Enrollment: | 8 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
Drug: rituximab [Mabthera/Rituxan]
375 mg/m2 intravenously, day 1 of each 28-day cycle, up to 8 cycles
Drug: fludarabine
as prescribed, 6 cycles
Drug: cyclophosphamide
as prescribed, 6 cycles
Drug: mitoxantrone
as prescribed, 6 cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients, >/=18 years of age
- untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation
- known mantle cell lymphoma international prognostic index (MIPI) at diagnosis
- ECOG performance status 0-2
- adequate hematological, renal and hepatic function
Exclusion Criteria:
- known hypersensitivity to murine proteins or chemotherapy regimen
- previous first-line therapy
- history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
- active infection
- clinically significant cardiac disease
- regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144403
Locations
| Romania | |
| Brasov, Romania, 500326 | |
| Bucharest, Romania, 022328 | |
| Bucharest, Romania, 005098 | |
| Bucuresti, Romania, 030171 | |
| Cluj-napoca, Romania, 400015 | |
| Iasi, Romania, 700111 | |
| Targu-mures, Romania, 540136 | |
| Timisoara, Romania, 300079 | |
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: | NCT01144403 History of Changes |
| Other Study ID Numbers: | ML22489, 2009-011433-27 |
| Study First Received: | June 14, 2010 |
| Last Updated: | June 3, 2013 |
| Health Authority: | Romania: National Medicines Agency |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Fludarabine monophosphate Rituximab Fludarabine Mitoxantrone |
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 Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013