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 range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Response Rate (ORR)

Timeframe: 78 - 85 days + 2 years Follow Up

Maximum tolerated dose (MTD)

Timeframe: 78 - 85 days

Trial details

NCT IDNCT02983097

SponsorGesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01

View on ClinicalTrials.gov More Diffuse Large B-cell Lymphoma (DLBCL) trials