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

NCT ID: NCT01553786

Last Updated: 2021-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2019-03-21

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.

Conditions

T-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

lenalidomide

lenalidomide + CHOP

Group Type: EXPERIMENTAL

Lenalidomide

Intervention Type: DRUG

Lenalidomide

Interventions

Lenalidomide

Lenalidomide

Intervention Type: DRUG

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).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Lymphoma Academic Research Organisation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corinne HAIOUN

Role: PRINCIPAL_INVESTIGATOR

Lymphoma Study Association

Locations

Université Catholique de Louvain Saint Luc

Brussels, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Université Catholique de Louvain Mont Godinne

Yvoir, , Belgium

CHU d'Amiens - Hôpital Sud

Amiens, , France

CHU Angers

Angers, , France

CH d'Avignon - Hôpital Henri Duffaut

Avignon, , France

CHU Jean Minjoz

Besançon, , France

Institut Bergonié

Bordeaux, , France

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, , France

Centre hospitalier Chalon sur Saone William Morey

Châlon Sur Saône, , France

CHU Estaing

Clermont-Ferrand, , France

CH Sud Francilien de Corbeil

Corbeil-Essonnes, , France

Hôpital Henri Mondor

Créteil, , France

CHU de Dijon

Dijon, , France

CHU de Grenoble

Grenoble, , France

CH Départemental

La Roche-sur-Yon, , France

CHRU de Lille

Lille, , France

Institut Paoli Calmette

Marseille, , France

Centre Hospitalier de Meaux

Meaux, , France

CHU Saint-Eloi

Montpellier, , France

CHU Hôtel Dieu

Nantes, , France

Hôpital Saint Louis

Paris, , France

Hôpital Necker

Paris, , France

Centre Francois Magendie

Pessac, , France

CHU Lyon Sud

Pierre-Bénite, , France

Centre Hospitalier de la Région d'Annecy

Pringy, , France

CHU Robert Debré

Reims, , France

CHU Pontchaillou

Rennes, , France

Centre Henri Becquerel

Rouen, , France

CHU Brabois

Vandœuvre-lès-Nancy, , France

Countries

Belgium; France

References

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.

Reference Type: DERIVED

PMID: 33496747 (View on PubMed)

Other Identifiers

REVAIL

Identifier Type: -

Identifier Source: org_study_id