NCT02983097

Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP

Open-label, Multicenter Phase I/II Study: Salvage Therapy of Progressive and Relapsed Aggressive Non-Hodgkin-Lymphoma by Combination of Lenalidomide (Revlimid®) With Rituximab, Dexamethason, High-dose ARA-C and Cisplatinum (R²-DHAP)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate efficacy and safety of the combination of lenalidomide, an immunomodulatory drug (IMiD) with a standard immunochemotherapy treatment, called R-DHAP. R-DHAP consists of a monoclonal antibody called Rituximab and chemotherapy consisting of Dexamethasone, high dose Cytarabine, often called Ara-C, and platinum based chemotherapy, either cisplatinum, or, if treatment with cisplatinum is contraindicated, carboplatinum.

Detailed description

This is a phase 1/2 study to evaluate the efficacy and safety of lenalidomide added to a standard chemotherapy regime of R-DHAP (Rituximab, Dexamethasone, high-dose Cytarabine, Cis/Carboplatinum) in the treatment of relapsed or refractory high-grade B-cell non-hodgkin-lymphoma (NHL). The study hypothesis is that the combination of lenalidomide with standard immunochemotherapy will lead to an overall response rate of at least 60%. In this study, 3 rounds of immunochemotherapy in combination with lenalidomide will be administered. After the first or second round of therapy, peripheral hematopoetic stem cells will be harvested. Consolidation treatment with autologous or allogenic peripheral blood stem cell transplantation is recommended in all patients suitable, but is not part of the study. In phase 1, up to six cohorts of at least 6 patients each will be treated with the study therapy, with lenalidomide in increasing dosages, to determine the maximum tolerated dose (MTD). In phase 2, 50 patients will be treated with the MTD. Efficacy and safety will be evaluated.

Conditions

• Diffuse Large B-cell Lymphoma (DLBCL)
• Follicular Lymphoma Grade III (FL III°)
• Mantle Cell Lymphoma (MCL), Blastoid Variant
• Burkitt Lymphoma (BL)
• Aggressive Marginal Zone Lymphoma (MZL)

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab 375 mg/m²
DRUG	Cisplatin	Cisplatinum 100 mg / m²
DRUG	Carboplatin	Carboplatinum AUC5
DRUG	Dexamethasone	Dexamethasone 40 mg
DRUG	Cytarabine	Cytarabine 2000 mg/m², administered twice
DRUG	Lenalidomide	5-20 mg administered either d1-d7, or d-6-d7
DRUG	PegFilgrastim	PegFilgrastim 6 mg
PROCEDURE	peripheral stem cell collection	collection of peripheral stem cells for autologous stem cell transplantation

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-01-01
• Completion: 2015-04-28
• First posted: 2016-12-06
• Last updated: 2018-01-19

Locations

12 sites across 1 country: Germany