Efficacy of a Treatment With CHOP and Lenalidomide in First Line in Angioimmunoblastic T-cell Lymphoma (AITL)
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)
1 other identifier
interventional
80
2 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2011
Longer than P75 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 20, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2019
CompletedJuly 26, 2021
July 1, 2021
6.3 years
January 20, 2012
July 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete response rate
maximum 60 days after last study drug intake
Study Arms (1)
lenalidomide
EXPERIMENTALlenalidomide + CHOP
Interventions
Eligibility Criteria
You may qualify if:
- Patients with histologically proven T-cell angioimmunoblastic lymphoma (AITL)
- Age from 60 to 80 years.
- Eastern Cooperative Oncology Group performance status 0 to 2.
- 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.
You may not qualify if:
- Others categories of T-cell lymphoma.
- Central nervous system involvement by lymphoma.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Université Catholique de Louvain Saint Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Université Catholique de Louvain Mont Godinne
Yvoir, 5530, Belgium
CHU d'Amiens - Hôpital Sud
Amiens, 80054, France
CHU Angers
Angers, 49033, France
CH d'Avignon - Hôpital Henri Duffaut
Avignon, 84902, France
CHU Jean Minjoz
Besançon, 25030, France
Institut Bergonié
Bordeaux, 33076, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33077, France
Centre hospitalier Chalon sur Saone William Morey
Châlon Sur Saône, 71100, France
CHU Estaing
Clermont-Ferrand, 63000, France
CH Sud Francilien de Corbeil
Corbeil-Essonnes, 91106, France
Hôpital Henri Mondor
Créteil, 94010, France
CHU de Dijon
Dijon, 21000, France
CHU de Grenoble
Grenoble, 38043, France
CH Départemental
La Roche-sur-Yon, 85925, France
CHRU de Lille
Lille, 59037, France
Institut Paoli Calmette
Marseille, 13273, France
Centre Hospitalier de Meaux
Meaux, 77104, France
CHU Saint-Eloi
Montpellier, 34295, France
CHU Hôtel Dieu
Nantes, 44093, France
Hôpital Saint Louis
Paris, 75475, France
Hôpital Necker
Paris, 75743, France
Centre Francois Magendie
Pessac, 33604, France
CHU Lyon Sud
Pierre-Bénite, France
Centre Hospitalier de la Région d'Annecy
Pringy, 74370, France
CHU Robert Debré
Reims, 51092, France
CHU Pontchaillou
Rennes, 35003, France
Centre Henri Becquerel
Rouen, 76038, France
CHU Brabois
Vandœuvre-lès-Nancy, 54511, France
Related Publications (1)
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.
PMID: 33496747DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Corinne HAIOUN
Lymphoma Study Association
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2012
First Posted
March 14, 2012
Study Start
November 1, 2011
Primary Completion
March 1, 2018
Study Completion
March 21, 2019
Last Updated
July 26, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share