Clinical trial NCT01553786: Efficacy of a Treatment With CHOP and Lenalidomide in First Line in Angioimmunoblastic T-cell Lymphoma (AITL)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: T-cell Lymphoma
Keywords: T-cell lymphoma
CHOp
lenalidomide
Lead sponsor: The Lymphoma Academic Research Organisation
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 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 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 Pregnancy Prevention Plan in appendix L of the protocol)

  * The Pregnancy Prevention Plan 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).

Primary outcomes:
measure: Complete response rate
timeFrame: maximum 60 days after last study drug intake
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Université Catholique de Louvain Saint Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Yvoir
country: Belgium
facility: Université Catholique de Louvain Mont Godinne
city: Amiens
country: France
facility: CHU d'Amiens - Hôpital Sud
city: Angers
country: France
facility: CHU Angers
city: Avignon
country: France
facility: CH d'Avignon - Hôpital Henri Duffaut
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Châlon sur saône
country: France
facility: Centre hospitalier Chalon sur Saone William Morey
city: Clermont Ferrand
country: France
facility: CHU Estaing
city: Corbeil Essonnes
country: France
facility: CH Sud Francilien de Corbeil
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU de Grenoble
city: La roche sur Yon
country: France
facility: CH Départemental
city: Lille
country: France
facility: CHRU de Lille
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Meaux
country: France
facility: Centre Hospitalier de Meaux
city: Montpellier
country: France
facility: CHU Saint-Eloi
city: Nantes
country: France
facility: CHU Hôtel Dieu
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Hôpital Necker
city: Pessac
country: France
facility: Centre Francois Magendie
city: Pierre Bénite
country: France
facility: CHU Lyon Sud
city: Pringy
country: France
facility: Centre Hospitalier de la Région d'Annecy
city: Reims
country: France
facility: CHU Robert Debré
city: Rennes
country: France
facility: CHU Pontchaillou
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Vandoeuvre les Nancy
country: France
facility: CHU Brabois
Study officials:
affiliation: Lymphoma Study Association
name: Corinne HAIOUN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemonnier F, Safar V, Beldi-Ferchiou A, Cottereau AS, Bachy E, Cartron G, Fataccioli V, Pelletier L, Robe C, Letourneau A, Missiaglia E, Fourati S, Moles-Moreau MP, Delmer A, Bouabdallah R, Voillat L, Becker S, Bossard C, Parrens M, Casasnovas O, Cacheux V, Regny C, Camus V, Delfau-Larue MH, Meignan M, de Leval L, Gaulard P, Haioun C. Integrative analysis of a phase 2 trial combining lenalidomide with CHOP in angioimmunoblastic T-cell lymphoma. Blood Adv. 2021 Jan 26;5(2):539-548. doi: 10.1182/bloodadvances.2020003081.