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

NCT02983097 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-01-19

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

    lead OTHER

Principal Investigators

  • Bertram Glaß, MD · AK St.Georg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-01-31
Completion
2015-04-28

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02983097 on ClinicalTrials.gov