Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas (MAINTAIN)
This study is currently recruiting participants.
Verified February 2013 by University of Giessen
Sponsor:
Jurgen Barth
Collaborator:
Sponsor GmbH
Information provided by (Responsible Party):
Jurgen Barth, University of Giessen
ClinicalTrials.gov Identifier:
NCT00877214
First received: April 6, 2009
Last updated: February 11, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to determine if an extended maintenance therapy with Rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Follicular Lymphomas Immunocytomas Marginal Zone Lymphomas Mantle-Cell Lymphomas Non-Hodgkin's Lymphoma |
Drug: Rituximab Drug: Rituximab / observation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Multicenter Study in First-line Treatment of Advanced progredIeNT Follicular And Other IndoleNt and Mantle Cell Lymphomas |
Resource links provided by NLM:
Further study details as provided by University of Giessen:
Primary Outcome Measures:
- Progression free survival [ Time Frame: 5 years and ongoing ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Remission rate and duration; event free-, progression free-, disease free- and over all survival [ Time Frame: 5 years and ongoing ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1134 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | April 2020 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rituximab |
Drug: Rituximab
Follicular Lymphomas: induction therapy with bendamustine + rituximab. If CR or PR: Maintenance therapy with rituximab every 2 months for 4 years Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years
Other Names:
|
|
Active Comparator: Standard
Rituximab / Observation
|
Drug: Rituximab / observation
Follicular Lymphomas:induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years (standard) Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: observation (standard)
Other Names:
|
Detailed Description:
Results from several randomised studies show a clinical benefit of a maintenance therapy with rituximab in follicular lymphomas. The advantage of a maintenance therapy in other indolent and mantle cell lymphomas is - due to the lower incidence of these diseases- not well investigated.
This study tries to determine the significance of an extended maintenance therapy with rituximab in follicular lymphomas and the significance of a maintenance therapy other indolent and mantle cell lymphomas compared to observation.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients with histological verified CD20-positive B-Cell-Lymphoma of the following entities:
- Follicular Lymphoma Grade 1 and 2
- Lymphoplasmocytic lymphoma / Immunocytoma (Morbus Waldenström) and small cell lymphocytic lymphoma (CLL without leukemic hemogram)
- Marginal zone lymphoma, nodal and extra nodal
- Mantle cell lymphoma
- No prior therapy with cytotoxics, interferon or monoclonal antibodies
- Need for therapy, except mantle cell lymphomas
- Stadium III or IV or Stadium with II bulky disease (> 7 cm diameter, or 3 lesions > 5 cm)
- General condition WHO 0-2
- Age min. 18 years, max. 80 years
- Negative pregnancy test, contraceptives mandatory for women of child-bearing age
- Actual histology, not older than 6 months required
- Written informed consent
Exclusion Criteria:
- Patients not meeting the inclusion criteria above
- Possibility of a primary radiation therapy with curative intention
- Pretreatment, except a single, localized radiation therapy (radiation field not larger than 2 adjacent lymph node regions)
Co-morbidities, excluding a therapy according to the protocol:
- severe, medicinal not adjustable hypertension
- severe limited capacity of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver and kidneys (creatinin > 2 mg/dl, GOT and GPT or bilirubin 3 x ULN), except if caused by lymphoma
- severe, medicinal not adjustable diabetes mellitus
- active autoimmune disease
- active infection, requiring antibiotic therapy
- Patients with proven HIV-infection
- Active replicating hepatitis-Infection
- Severe psychiatric diseases
- Lacking or anticipated non-compliance
- Known hypersensitivity against the active components or additives or mouse- proteins
- Pregnant or nursing women
- Patients with a secondary malignancy or malignant disease in his history if, curative surgery can not be doubtless assured .
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877214
Contacts
| Contact: Mathias Rummel, Dr | +4964198542 ext 650 | mathias.rummel@innere.med.uni-giessen.de |
| Contact: Jürgen Barth | +4964198542 ext 603 | juergen.barth@innere.med.uni-giessen.de |
Locations
| Germany | |
| StiL Head Office; Justus-Liebig-University | Recruiting |
| Giessen, Germany, 35392 | |
| Contact: Mathias Rummel, Dr. +4964198542 ext 650 mathias.rummel@innere.med.uni-giessen.de | |
| Contact: Jürgen Barth +4964198542 ext 603 juergen.barth@innere.med.uni-giessen.de | |
| Principal Investigator: Mathias Rummel, Dr | |
Sponsors and Collaborators
Jurgen Barth
Sponsor GmbH
Investigators
| Principal Investigator: | Mathias Rummel, Dr | University of Giessen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jurgen Barth, Professor Mathias Rummel, University of Giessen |
| ClinicalTrials.gov Identifier: | NCT00877214 History of Changes |
| Other Study ID Numbers: | NHL 7-2008 |
| Study First Received: | April 6, 2009 |
| Last Updated: | February 11, 2013 |
| Health Authority: | Germany: Paul-Ehrlich-Institut Germany: Ethics Commission |
Keywords provided by University of Giessen:
|
Bendamustine Rituximab Significance of maintenance therapy Efficacy and safety |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, B-Cell, Marginal Zone Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, B-Cell Bendamustine Rituximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013