Clinical trial NCT01933711: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma
Keywords: CD20+ aggressive lymphoma
mantle cell lymphoma
rituximab
maintenance
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression free survival
timeFrame: 24 months after randomization
Secondary outcomes:
measure: time to progression (TTP)
timeFrame: 24 months after randomization
measure: overall survival (OS)
timeFrame: 24 months after randomization
measure: response to treatment
timeFrame: 24 months after randomization
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg Hospital
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: University of Mannheim Hospital
state: Baden-Württemberg
city: Bonn
country: Germany
facility: University of Bonn Hospital
state: Nordhein-Westfalen
Study officials:
References: