Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C… (NCT02983097) | Clinical Trial Compass
TerminatedPhase 1/2
Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP
Stopped: Phase II: no scientific interests are given anymore
Germany34 participantsStarted 2010-11
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
Age: 18-70
Risk groups: All risk groups
histology: diagnosis or a recurrent or primary progressive aggressive b-cell non-hodgkin lymphoma, in particular
* follicular lymphoma grade III
* diffuse large b-cell lymphoma
* burkitt lymphoma
* mantle cell lymphoma, blastoid variant
* aggressive marginal zone lymphoma
Performance status: ECOG 0-2
Criteria for women of childbearing potential:
Women of childbearing potential have to:
* understand the teratogenic risk associated with the study therapy, especially lenalidomide
* understand the need of reliable, uninterrupted birth control from 4 weeks prior to the start of the study drug, during the duration of the study treatment, and 4 weeks after completion of study treatment, and be able to reliably use birth control, except if the patient commits to absolute sexual abstinence, confirmed on a monthly basis
The following are effective methods of contraception:
* implant
* levonorgestrel-releasing intrauterine system (IUS)
* medroxyprogesterone acetate depot
* tubal sterilisation
* sexual intercourse with a vasectomised male partner only, vasectomy must be confirmed by two negative semen analyses
* ovulation-inhibitory progesterone-only pills If not established on effective contraception, the female subject must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
* Understand that even if she has amenorrhea, she must follo…
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: 78 - 85 days + 2 years Follow Up
2
Maximum tolerated dose (MTD)
Timeframe: 78 - 85 days
Trial details
NCT IDNCT02983097
SponsorGesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH