Efficacy of a Treatment With CHOP and Lenalidomide in First Line in Angioimmunoblastic T-cell Lymphoma (AITL)

Sponsor

The Lymphoma Academic Research Organisation (Other)

Overall Status

Completed

CT.gov ID

NCT01553786

Collaborator

(none)

Enrollment

Locations

Arm

88.6

Actual Duration (Months)

2.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
T-cell Lymphoma	Drug: Lenalidomide	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lenalidomide lenalidomide + CHOP	Drug: Lenalidomide Lenalidomide

Arm

Intervention/Treatment

Experimental: lenalidomide

lenalidomide + CHOP

Drug: Lenalidomide

Lenalidomide

Outcome Measures

Primary Outcome Measures

Complete response rate [maximum 60 days after last study drug intake]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Université Catholique de Louvain Saint Luc	Bruxelles	Belgium	1200
2	Universitair Ziekenhuis Gent	Gent	Belgium	9000
3	Université Catholique de Louvain Mont Godinne	Yvoir	Belgium	5530
4	CHU d'Amiens - Hôpital Sud	Amiens	France	80054
5	CHU Angers	Angers	France	49033
6	CH d'Avignon - Hôpital Henri Duffaut	Avignon	France	84902
7	CHU Jean Minjoz	Besançon	France	25030
8	Institut Bergonié	Bordeaux	France	33076
9	Polyclinique Bordeaux Nord Aquitaine	Bordeaux	France	33077
10	Centre hospitalier Chalon sur Saone William Morey	Châlon sur saône	France	71100
11	CHU Estaing	Clermont Ferrand	France	63000
12	CH Sud Francilien de Corbeil	Corbeil Essonnes	France	91106
13	Hôpital Henri Mondor	Créteil	France	94010
14	CHU de Dijon	Dijon	France	21000
15	CHU de Grenoble	Grenoble	France	38043
16	CH Départemental	La roche sur Yon	France	85925
17	CHRU de Lille	Lille	France	59037
18	Institut Paoli Calmette	Marseille	France	13273
19	Centre Hospitalier de Meaux	Meaux	France	77104
20	CHU Saint-Eloi	Montpellier	France	34295
21	CHU Hôtel Dieu	Nantes	France	44093
22	Hôpital Saint Louis	Paris	France	75475
23	Hôpital Necker	Paris	France	75743
24	Centre Francois Magendie	Pessac	France	33604
25	CHU Lyon Sud	Pierre Bénite	France
26	Centre Hospitalier de la Région d'Annecy	Pringy	France	74370
27	CHU Robert Debré	Reims	France	51092
28	CHU Pontchaillou	Rennes	France	35003
29	Centre Henri Becquerel	Rouen	France	76038
30	CHU Brabois	Vandoeuvre les Nancy	France	54511