Trial record 8 of 140 for:    Open Studies | "Aggression"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University Hospital Heidelberg
Sponsor:
Information provided by (Responsible Party):
Mathias Witzens-Harig, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01933711
First received: August 23, 2013
Last updated: August 28, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University Hospital Heidelberg:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
    Primary endpoint of the study was progression free survival (PFS)


Secondary Outcome Measures:
  • time to progression (TTP) [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  • overall survival (OS) [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  • response to treatment [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 328
Study Start Date: July 2002
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933711

Contacts
Contact: Mathias Witzens-Harig, MD +49 6221 568008 mathias.witzens-harig@med.uni-heidelberg.de

Locations
Germany
University of Heidelberg Hospital Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Principal Investigator: Mathias Witzens-Harig, MD         
University of Mannheim Hospital Recruiting
Mannheim, Baden-Württemberg, Germany, 68167
Principal Investigator: Eva Lengfelder, MD         
University of Bonn Hospital Recruiting
Bonn, Nordhein-Westfalen, Germany, 53127
Principal Investigator: Ingo Schmidt-Wolf, MD         
Sponsors and Collaborators
University Hospital Heidelberg
  More Information

No publications provided

Responsible Party: Mathias Witzens-Harig, Priv.Doz Dr.med., University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01933711     History of Changes
Other Study ID Numbers: HD2002
Study First Received: August 23, 2013
Last Updated: August 28, 2013
Health Authority: Regierungspräsidium Karlsruhe, Germany:

Keywords provided by University Hospital Heidelberg:
CD20+ aggressive lymphoma
mantle cell lymphoma
rituximab
maintenance

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

ClinicalTrials.gov processed this record on September 16, 2014