Efficacy of a Treatment With CHOP and Lenalidomide in First Line in Angioimmunoblastic T-cell Lym… (NCT01553786) | Clinical Trial Compass
CompletedPhase 2
Efficacy of a Treatment With CHOP and Lenalidomide in First Line in Angioimmunoblastic T-cell Lymphoma (AITL)
Belgium, France80 participantsStarted 2011-11
Plain-language summary
This study aims to evaluate the efficacy of lenalidomide associated with CHOP as measured by complete response rate at the end of treatment. Approximately 80 patients aged between 60 and 80 years will be included, to have 70 evaluable patients. The treatment consists of two phases of four 3-weeks cycles: induction phase and consolidation phase, for a total treatment duration of 24 weeks. Each cycle will be broken down as follows: chemotherapy will be administered in the hospital on day 1, prednisone is continued for 5 days and lenalidomide is taken for 14 days. Patients will be followed for at least 18 months after inclusion of the last patient.
Who can participate
Age range60 Years – 80 Years
SexALL
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Inclusion Criteria:
* Patients with histologically proven T-cell angioimmunoblastic lymphoma (AITL)
* Age from 60 to 80 years.
* Eastern Cooperative Oncology Group performance status 0 to 2.
* No previous therapy (except corticosteroids providing they have been initiated less than 15 days before inclusion).
* Spontaneous life expectancy \> 1 month.
* Written informed consent. The Lenalidomide Information Sheet (in appendix N of the protocol) will be given to each patient receiving lenalidomide study therapy. The patient must read this document prior to starting lenalidomide study treatment and each time they receive a new supply of study drug.
* Male patients must:
* Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
* Agree to not give semen or sperm during study drug therapy and for a period after end of study drug therapy.
* All patients must:
* Have an understanding that the study drug could have a potential teratogenicity.
* Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
* Agree not to share study medication with another person.
* Be counselled about pregnancy precautions and risks of foetal exposure.
Exclusion Criteria:
* Others categories of T-cell lymphoma.
* Central nervous system involvement by lymphoma.
* Any previous therapy for lymphoma…
What they're measuring
1
Complete response rate
Timeframe: maximum 60 days after last study drug intake
Trial details
NCT IDNCT01553786
SponsorThe Lymphoma Academic Research Organisation