STUDY OF THE EFFICACY AND SAFETY OF FIRST LINE TREATMENT WITH CHOP AND LENALIDOMIDE (Rev-CHOP) IN PATIENTS AGED FROM 60 TO 80 YEARS WITH PREVIOUSLY UNTREATED ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (AITL)
- 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 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.
- Others categories of T-cell lymphoma.
- Central nervous system involvement by lymphoma.
- Any previous therapy for lymphoma except short-term corticosteroids (maximum 10 days)
- 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
- 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 malignancy, other than that treated in this research, unless the
patient has remained free of the disease for over 5 years.
- 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 L of the
- The PPP defines a female of childbearing potential as a sexually mature woman
who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not
been naturally postmenopausal (amenorrhea following cancer therapy does not rule
out childbearing potential) for at least 24 consecutive months (i.e., has had
menses at any time in the preceding 24 consecutive months).