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Rituximab Maintenance Therapy in Aggressive CD20 (Cluster of Differentiation Antigen 20) Positive Lymphoma and Mantle Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01933711
First Posted: September 2, 2013
Last Update Posted: May 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mathias Witzens-Harig, University Hospital Heidelberg
  Purpose
Clinical and pharmacokinetic data suggest that the effect of rituximab could be improved by prolonged exposure to the drug. To test for this hypothesis we performed a prospective randomized trial of rituximab maintenance therapy versus observation in patients (pts) with aggressive CD20+ B-cell lymphoma and mantle cell lymphoma.

Condition Intervention Phase
CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma Drug: rituximab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rituximab Maintenance Therapy Versus Observation in Aggressive CD20+ Lymphoma and Mantle Cell Lymphoma - a Prospective Randomized Phase III Trial

Resource links provided by NLM:


Further study details as provided by Mathias Witzens-Harig, University Hospital Heidelberg:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 24 months after randomization ]
    Primary endpoint of the study was progression free survival (PFS)


Secondary Outcome Measures:
  • time to progression (TTP) [ Time Frame: 24 months after randomization ]
  • overall survival (OS) [ Time Frame: 24 months after randomization ]
  • response to treatment [ Time Frame: 24 months after randomization ]

Estimated Enrollment: 328
Study Start Date: July 2002
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab maintenance
maintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years.
Drug: rituximab
No Intervention: Observation
observational arm, no intervention

Detailed Description:
After completion of standard treatment, pts with aggressive CD20+ B-cell lymphoma and mantle cell lymphoma were randomized to either observation or maintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years. Both pts after first line therapy and pts after relapse treatment were included in the study. Pts with aggressive lymphoma were enrolled if they had achieved a complete response (CR) after initial treatment. Pts with aggressive lymphoma with residual tumor mass underwent positron emission tomography (PET) and qualified for randomization if this examination showed no signs of tumor activity. Pts with mantle cell lymphoma were eligible for the study if at least a partial response (PR) was achieved. Primary endpoint of the study was progression free survival (PFS), secondary endpoints were time to progression (TTP), overall survival (OS) and response to treatment. Differences between PFS and OS were analysed using the logrank test and the proportional hazard model of Cox. TTP was analyzed using a competing risk model with death as competing event.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aggressive B-cell lymphoma or mantle cell lymphoma
  • CR (complete remission) oder CRu (complete remission unconfirmed) after previous therapy
  • PR (partial remission) only when PET is negative
  • minimal age 18 years
  • CD20+ expression on tumor cells
  • effective contraception
  • Karnofsky status > 60
  • written informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933711


Locations
Germany
University of Heidelberg Hospital
Heidelberg, Baden-Württemberg, Germany, 69120
University of Mannheim Hospital
Mannheim, Baden-Württemberg, Germany, 68167
University of Bonn Hospital
Bonn, Nordhein-Westfalen, Germany, 53127
Sponsors and Collaborators
University Hospital Heidelberg
  More Information

Responsible Party: Mathias Witzens-Harig, Priv.Doz Dr.med., University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01933711     History of Changes
Other Study ID Numbers: HD2002
First Submitted: August 23, 2013
First Posted: September 2, 2013
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by Mathias Witzens-Harig, University Hospital Heidelberg:
CD20+ aggressive lymphoma
mantle cell lymphoma
rituximab
maintenance

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Aggression
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Behavioral Symptoms
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents