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

Sponsor
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Study ID
NCT02983097
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 30, 2010
Status verified
Dec 2016
Primary completion
Jan 31, 2014
Completion
Apr 28, 2015

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R²-DHAP
    Combination treatment with immunochemotherapy (R-DHAP) and lenalidomide Dosage: Rituximab 375 mg/m² day 1, i.v. Cisplatin 100 mg/m² or Carboplatin AUC5 day 2, i.v. Cytarabine 2000 mg/m², administered twice, on day 3, i.v. Dexamethasone 40 mg, days 2-5, p.o. Lenalidomide 5-20 mg, day 1-7 / day-6-+7, p.o. PEG-Filgrastim 6 mg, day 6, s.c. peripheral stem cell collection after cycle 1 or 2

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 78 - 85 days + 2 years Follow Up ]

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