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

CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma Clinical Trial

Official title:

Rituximab Maintenance Therapy Versus Observation in Aggressive CD20+ Lymphoma and Mantle Cell Lymphoma - a Prospective Randomized Phase III Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01933711
• Other study ID #: HD2002
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 23, 2013
• Last updated: May 11, 2016
• Start date: July 2002
• Est. completion date: December 2018

Study information

• Verified date: May 2016
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Regierungspräsidium Karlsruhe, Germany:
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 328
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma
• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Drug:
• rituximab

Locations

Country	Name	City	State
Germany	University of Bonn Hospital	Bonn	Nordhein-Westfalen
Germany	University of Heidelberg Hospital	Heidelberg	Baden-Württemberg
Germany	University of Mannheim Hospital	Mannheim	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Primary endpoint of the study was progression free survival (PFS)	24 months after randomization	No
Secondary	time to progression (TTP)		24 months after randomization	No
Secondary	overall survival (OS)		24 months after randomization	No
Secondary	response to treatment		24 months after randomization	No