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

Phase 2

Completed

• Conditions: T-cell Lymphoma
• Interventions: Drug: Lenalidomide

• Registration Number: NCT01553786
• Lead Sponsor: The Lymphoma Academic Research Organisation

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-20
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-14
• Primary Completion: 2018-03
• Study Completion: 2019-03-21
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lenalidomide	Lenalidomide	lenalidomide + CHOP

Primary Outcome Measures

Name	Time	Method
Complete response rate	maximum 60 days after last study drug intake

Trial Locations

Locations (30)

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

CHU Lyon Sud; 🇫🇷 Pierre Bénite, France

CHU Angers; 🇫🇷 Angers, France

CHRU de Lille; 🇫🇷 Lille, France

Université Catholique de Louvain Saint Luc; 🇧🇪 Bruxelles, Belgium

Université Catholique de Louvain Mont Godinne; 🇧🇪 Yvoir, Belgium

Hôpital Necker; 🇫🇷 Paris, France

CHU Pontchaillou; 🇫🇷 Rennes, France

CH d'Avignon - Hôpital Henri Duffaut; 🇫🇷 Avignon, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre hospitalier Chalon sur Saone William Morey; 🇫🇷 Châlon sur saône, France

CHU Saint-Eloi; 🇫🇷 Montpellier, France

CHU Brabois; 🇫🇷 Vandoeuvre les Nancy, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CHU Jean Minjoz; 🇫🇷 Besançon, France

CHU de Dijon; 🇫🇷 Dijon, France

CHU Estaing; 🇫🇷 Clermont Ferrand, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CH Départemental; 🇫🇷 La roche sur Yon, France

Institut Paoli Calmette; 🇫🇷 Marseille, France

Centre Hospitalier de Meaux; 🇫🇷 Meaux, France

CHU Hôtel Dieu; 🇫🇷 Nantes, France

Centre Francois Magendie; 🇫🇷 Pessac, France

Centre Hospitalier de la Région d'Annecy; 🇫🇷 Pringy, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

CHU d'Amiens - Hôpital Sud; 🇫🇷 Amiens, France

CH Sud Francilien de Corbeil; 🇫🇷 Corbeil Essonnes, France

CHU Robert Debré; 🇫🇷 Reims, France

Hôpital Saint Louis; 🇫🇷 Paris, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France