STUDY OF THE EFFICACY AND SAFETY OF TREATMENT WITH CHOP AND LENALIDOMIDE (Rev-CHOP) WITH PREVIOUSLY UNTREATED ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (AITL).

Phase 1

• Conditions: Angioimmunoblastic T-cell Lymphoma (AITL); MedDRA version: 20.0 Level: PT Classification code 10002449 Term: Angioimmunoblastic T-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001356-10-BE
• Lead Sponsor: YSARC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

• Patients with histologically proven T-cell angioimmunoblastic lymphoma (AITL)
• Age from 60 to 80 years.
• ECOG 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 of the Patient Informed Consent Form) given to each patient receiving lenalidomide study therapy, must be read prior to starting treatment and at each 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

•Other categories of T-cell lymphoma.
• Central nervous system involvement by lymphoma.
• Any previous therapy for lymphoma except short-term corticosteroids (maximum 10 days) before inclusion.
• Contra-indication to any drug included in the CHOP regimen.
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator’s decision).
• Active bacterial, viral or fungal infection, in particular active hepatitis B or C and HIV positive serological test.
• Impaired renal function (Creatinine clearance < 50 ml/min),as calculated by the Cockcroft-Gault formula) or impaired liver function tests (total bilirubin level > 30 µmol/L, transaminases > 2.5 upper normal limits) unless they are related to the lymphoma.
• Poor bone marrow reserve as defined by neutrophils < 1.0 x 109/L or platelets < 100 x 109/L, unless related to bone marrow infiltration.
• Any history of cancer during the last 5 years, with the exception of non basal cell carcinoma of the skin or in situ carcinoma of the cervix.
• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
• Hypersensitivity to the active substance or to any of the excipients.
• Pregnant and lactating woman
• Females of Childbearing potential (FCBP*) according to the PPP (in appendix 18.13 of the protocol)
*A FCBP isa female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified