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

Primary Purpose

CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
rituximab
Sponsored by
University Hospital Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma focused on measuring CD20+ aggressive lymphoma, mantle cell lymphoma, rituximab, maintenance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Heidelberg Hospital
  • University of Mannheim Hospital
  • University of Bonn Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rituximab maintenance

Observation

Arm Description

maintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years.

observational arm, no intervention

Outcomes

Primary Outcome Measures

Progression free survival
Primary endpoint of the study was progression free survival (PFS)

Secondary Outcome Measures

time to progression (TTP)
overall survival (OS)
response to treatment

Full Information

First Posted
August 23, 2013
Last Updated
May 11, 2016
Sponsor
University Hospital Heidelberg
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1. Study Identification

Unique Protocol Identification Number
NCT01933711
Brief Title
Rituximab Maintenance Therapy in Aggressive CD20 (Cluster of Differentiation Antigen 20) Positive Lymphoma and Mantle Cell Lymphoma
Official Title
Rituximab Maintenance Therapy Versus Observation in Aggressive CD20+ Lymphoma and Mantle Cell Lymphoma - a Prospective Randomized Phase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2002 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma
Keywords
CD20+ aggressive lymphoma, mantle cell lymphoma, rituximab, maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
328 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rituximab maintenance
Arm Type
Experimental
Arm Description
maintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years.
Arm Title
Observation
Arm Type
No Intervention
Arm Description
observational arm, no intervention
Intervention Type
Drug
Intervention Name(s)
rituximab
Primary Outcome Measure Information:
Title
Progression free survival
Description
Primary endpoint of the study was progression free survival (PFS)
Time Frame
24 months after randomization
Secondary Outcome Measure Information:
Title
time to progression (TTP)
Time Frame
24 months after randomization
Title
overall survival (OS)
Time Frame
24 months after randomization
Title
response to treatment
Time Frame
24 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Heidelberg Hospital
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University of Mannheim Hospital
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
University of Bonn Hospital
City
Bonn
State/Province
Nordhein-Westfalen
ZIP/Postal Code
53127
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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