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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01553786
Recruitment Status : Recruiting
First Posted : March 14, 2012
Last Update Posted : May 24, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
T-cell Lymphoma Drug: Lenalidomide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : November 2011
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : March 2020

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

Primary Outcome Measures :
  1. Complete response rate [ Time Frame: maximum 60 days after last study drug intake ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01553786

Contact: Yvain ROBREAU 0033 4 72 66 93 33

Université Catholique de Louvain Saint Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Eric VAN DEN NESTE    0032 27 64 18 75   
Principal Investigator: Eric VAN DEN NESTE, Dr         
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Contact: Fritz OFFNER    0032 93 32 21 32   
Principal Investigator: Fritz OFFNER, Pr         
Université Catholique de Louvain Mont Godinne Recruiting
Yvoir, Belgium, 5530
Contact: Marc ANDRE    00 32 81 42 38 64   
Principal Investigator: Marc ANDRE, Dr         
CHU d'Amiens - Hôpital Sud Recruiting
Amiens, France, 80054
Contact: Jean-Pierre MAROLLEAU    0033 322455914   
Principal Investigator: Jean-Pierre MAROLLEAU, Dr         
CHU Angers Recruiting
Angers, France, 49033
Contact: Marie-Pierre MOLES-MOREAU   
Principal Investigator: Marie-Pierre MOLES-MOREAU, Dr         
CH d'Avignon - Hôpital Henri Duffaut Recruiting
Avignon, France, 84902
Contact: Hacène ZERAZHI    0033 4 32 75 32 51   
Principal Investigator: Hacène ZERAZHI, Dr         
CHU Jean Minjoz Recruiting
Besançon, France, 25030
Contact: Eric DECONINCK    0033 3 81 66 82 32   
Principal Investigator: Eric DECONINCK, Pr         
Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Anna SCHMITT    0033 5 56 33 32 67   
Principal Investigator: Anna SCHMITT, Dr         
Polyclinique Bordeaux Nord Aquitaine Recruiting
Bordeaux, France, 33077
Contact: Olivier FITOUSSI    0033 5 56 43 73 54   
Principal Investigator: Olivier FITOUSSI, Dr         
Centre hospitalier Chalon sur Saone William Morey Recruiting
Châlon sur saône, France, 71100
Contact: Laurent VOILLAT    0033 3 85 44 66 98   
Principal Investigator: Laurent VOILLAT, Dr         
CHU Estaing Recruiting
Clermont Ferrand, France, 63000
Contact: Victoria CACHEUX    0033 4 73 75 00 65   
Principal Investigator: Victoria CACHEUX, Dr         
CH Sud Francilien de Corbeil Recruiting
Corbeil Essonnes, France, 91106
Contact: Bertrand JOLY    0033 1 60 90 31 46   
Principal Investigator: Bertrand JOLY, Dr         
Hôpital Henri Mondor Recruiting
Créteil, France, 94010
Contact: Corinne HAIOUN    0033 1 49 81 41 54   
Principal Investigator: Corinne HAIOUN, Pr         
CHU de Dijon Recruiting
Dijon, France, 21000
Contact: Olivier CASASNOVAS    0033 3 80 29 50 47   
Principal Investigator: Olivier CASASNOVAS, Dr         
CHU de Grenoble Recruiting
Grenoble, France, 38043
Contact: Remy GRESSION    0033 4 76 76 59 53   
Principal Investigator: Rémy GRESSIN, Dr         
CH Départemental Recruiting
La roche sur Yon, France, 85925
Contact: Hervé MAISONNEUVE    0033 2 51 44 61 61   
Principal Investigator: Hervé MAISONNEUVE, Dr         
CHRU de Lille Recruiting
Lille, France, 59037
Contact: Franck MORSCHHAUSER    0033 3 20 44 60 68   
Principal Investigator: Franck MORSCHHAUSER, Dr         
Institut Paoli Calmette Recruiting
Marseille, France, 13273
Contact: Réda BOUABDALLAH    0033 4 91 22 33 33   
Principal Investigator: Réda BOUABDALLAH, Dr         
Centre Hospitalier de Meaux Recruiting
Meaux, France, 77104
Contact: Wajed ABARAH - ATASI    0033 1 64 35 38 75   
Principal Investigator: Wajed ABARAH - ATASI, Dr         
CHU Saint-Eloi Recruiting
Montpellier, France, 34295
Contact: Guillaume CARTRON    0033 4 67 33 83 62   
Principal Investigator: Guillaume CARTRON, Pr         
CHU Hôtel Dieu Recruiting
Nantes, France, 44093
Contact: Steven LE GOUILL    0033 2 40 08 32 71   
Principal Investigator: Steven LE GOUILL, Dr         
Hôpital Saint Louis Recruiting
Paris, France, 75475
Contact: Catherine THIEBLEMONT    0033 1 42 49 98 37   
Principal Investigator: Catherine THIEBLEMONT, Pr         
Hôpital Necker Recruiting
Paris, France, 75743
Contact: Richard DELARUE    0033 1 44 49 52 97   
Principal Investigator: Richard DELARUE, Dr         
Centre Francois Magendie Recruiting
Pessac, France, 33604
Contact: Kamal BOUABDALLAH    0033 5 57 65 65 11   
Principal Investigator: Kamal BOUABDALLAH, Pr         
CHU Lyon Sud Recruiting
Pierre Bénite, France
Contact: Bertrand COIFFIER   
Principal Investigator: Bertrand COIFFIER, Pr         
Centre Hospitalier de la Région d'Annecy Recruiting
Pringy, France, 74370
Contact: Bernadette CORRONT    0033 4 50 63 66 08   
Principal Investigator: Bernadette CORRONT, Dr         
CHU Robert Debré Recruiting
Reims, France, 51092
Contact: Alain DELMER    0033 3 26 78 36 44   
Principal Investigator: Alain DELMER, Pr         
CHU Pontchaillou Recruiting
Rennes, France, 35003
Contact: Thierry LAMY    0033 2 99 28 42 92   
Principal Investigator: Thierry LAMY, Pr         
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Hervé TILLY    0033 2 32 08 22 02   
Principal Investigator: Hervé TILLY, Pr         
CHU Brabois Recruiting
Vandoeuvre les Nancy, France, 54511
Contact: Pierre FEUGIER    0033 3 83 15 32 82   
Principal Investigator: Pierre FEUGIER, Dr         
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Principal Investigator: Corinne HAIOUN Lymphoma Study Association

Responsible Party: The Lymphoma Academic Research Organisation Identifier: NCT01553786     History of Changes
Other Study ID Numbers: REVAIL
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

Keywords provided by The Lymphoma Academic Research Organisation:
T-cell lymphoma

Additional relevant MeSH terms:
Lymphoma, T-Cell
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents