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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by The Lymphoma Academic Research Organisation
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier:
NCT01553786
First received: January 20, 2012
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
T-cell Lymphoma
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by The Lymphoma Academic Research Organisation:

Primary Outcome Measures:
  • Complete response rate [ Time Frame: maximum 60 days after last study drug intake ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: November 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lenalidomide
lenalidomide + CHOP
Drug: Lenalidomide
Lenalidomide

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically proven T-cell angioimmunoblastic lymphoma (AITL)
  • Age from 60 to 80 years.
  • ECOG 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 PPP (in appendix L of the protocol)

    • The PPP 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553786

Contacts
Contact: Aude FIEVET 0033 4 72 66 93 33 aude.fievet@gelarc.org

Locations
Belgium
Université Catholique de Louvain Saint Luc Not yet recruiting
Bruxelles, Belgium, 1200
Contact: Eric VAN DEN NESTE    0032 27 64 18 75    eric.vandenneste@uclouvain.be   
Principal Investigator: Eric VAN DEN NESTE, Dr         
Universitair Ziekenhuis Gent Not yet recruiting
Gent, Belgium, 9000
Contact: Fritz OFFNER    0032 93 32 21 32    fritz.offner@ugent.be   
Principal Investigator: Fritz OFFNER, Pr         
Université Catholique de Louvain Mont Godinne Not yet recruiting
Yvoir, Belgium, 5530
Contact: Marc ANDRE    00 32 81 42 38 64    marc.andre@uclouvain.be   
Principal Investigator: Marc ANDRE, Dr         
France
CHU d'Amiens - Hôpital Sud Not yet recruiting
Amiens, France, 80054
Contact: Gandhi DAMAJ    0033 322455914    damaj.gandhi@chu-amiens.fr   
Principal Investigator: Gandhi DAMAJ, Dr         
CHU Angers Not yet recruiting
Angers, France, 49033
Contact: Marie-Pierre MOLES-MOREAU       mpmoles@chu-angers.fr   
Principal Investigator: Marie-Pierre MOLES-MOREAU, Dr         
CH d'Avignon - Hôpital Henri Duffaut Not yet recruiting
Avignon, France, 84902
Contact: Hacène ZERAZHI    0033 4 32 75 32 51    hzerazhi@ch-avignon.fr   
Principal Investigator: Hacène ZERAZHI, Dr         
CHU Jean Minjoz Not yet recruiting
Besançon, France, 25030
Contact: Eric DECONINCK    0033 3 81 66 82 32    edeconinck@chu-besancon.fr   
Principal Investigator: Eric DECONINCK, Pr         
Polyclinique Bordeaux Nord Aquitaine Active, not recruiting
Bordeaux, France, 33077
Institut Bergonié Not yet recruiting
Bordeaux, France, 33076
Contact: Pierre SOUBEYRAN    0033 5 56 33 32 67    soubeyran_p@bergonie.org   
Principal Investigator: Pierre SOUBEYRAN, Dr         
Centre hospitalier Chalon sur Saone William Morey Active, not recruiting
Châlon sur saône, France, 71100
CHU Estaing Not yet recruiting
Clermont Ferrand, France, 63000
Contact: Victoria CACHEUX    0033 4 73 75 00 65    vcacheux@chu-clermontferrand.fr   
Principal Investigator: Victoria CACHEUX, Dr         
CH Sud Francilien de Corbeil Not yet recruiting
Corbeil Essonnes, France, 91106
Contact: Bertrand JOLY    0033 1 60 90 31 46    bertrand.joly@ch-sud-francilien.fr   
Principal Investigator: Bertrand JOLY, Dr         
Hôpital Henri Mondor Recruiting
Créteil, France, 94010
Contact: Corinne HAIOUN    0033 1 49 81 41 54    corinne.haioun@hmn.aphp.fr   
Principal Investigator: Corinne HAIOUN, Pr         
CHU de Dijon Not yet recruiting
Dijon, France, 21000
Contact: Olivier CASASNOVAS    0033 3 80 29 50 47    olivier.casasnovas@chu-dijon.fr   
Principal Investigator: Olivier CASASNOVAS, Dr         
CHU de Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Remy GRESSION    0033 4 76 76 59 53    rgressin@chu-grenoble.fr   
Principal Investigator: Rémy GRESSIN, Dr         
CH Départemental Not yet recruiting
La roche sur Yon, France, 85925
Contact: Hervé MAISONNEUVE    0033 2 51 44 61 61    herve.maisonneuve@chd-vendee.fr   
Principal Investigator: Hervé MAISONNEUVE, Dr         
CHRU de Lille Not yet recruiting
Lille, France, 59037
Contact: Franck MORSCHHAUSER    0033 3 20 44 60 68    f-morschhauser@chru-lille.fr   
Principal Investigator: Franck MORSCHHAUSER, Dr         
Centre Léon Bérard Not yet recruiting
Lyon, France, 69373
Contact: Hervé GHESQUIERES    0033 4 78 78 29 89    herve.ghesquieres@lyon.unicancer.fr   
Principal Investigator: Hervé GHESQUIERES, Dr         
Institut Paoli Calmette Not yet recruiting
Marseille, France, 13273
Contact: Réda BOUABDALLAH    0033 4 91 22 33 33    bouabdallahr@marseille.fnclcc.fr   
Principal Investigator: Réda BOUABDALLAH, Dr         
Centre Hospitalier de Meaux Not yet recruiting
Meaux, France, 77104
Contact: Wajed ABARAH - ATASI    0033 1 64 35 38 75    w-abarah@ch-meaux.fr   
Principal Investigator: Wajed ABARAH - ATASI, Dr         
CHU Saint-Eloi Not yet recruiting
Montpellier, France, 34295
Contact: Guillaume CARTRON    0033 4 67 33 83 62    g-cartron@chu-montpellier.fr   
Principal Investigator: Guillaume CARTRON, Pr         
CHU Hôtel Dieu Not yet recruiting
Nantes, France, 44093
Contact: Steven LE GOUILL    0033 2 40 08 32 71    steven.legouill@chu-nantes.fr   
Principal Investigator: Steven LE GOUILL, Dr         
CHU de Nîmes - Caremeau Not yet recruiting
Nîmes, France, 30029
Contact: Pascal BOURQUARD    0033 4 66 68 32 31    pascal.bourquard@chu-nimes.fr   
Principal Investigator: Pascal BOURQUARD, Dr         
Hôpital Necker Not yet recruiting
Paris, France, 75743
Contact: Richard DELARUE    0033 1 44 49 52 97    richard.delarue@nck.ap-hop-paris.fr   
Principal Investigator: Richard DELARUE, Dr         
Hôpital Saint Louis Not yet recruiting
Paris, France, 75475
Contact: Catherine THIEBLEMONT    0033 1 42 49 98 37    catherine.thieblemont@sls.aphp.fr   
Principal Investigator: Catherine THIEBLEMONT, Pr         
Centre Francois Magendie Not yet recruiting
Pessac, France, 33604
Contact: Noel MILPIED    0033 5 57 65 65 11    noel.milpied@chu-bordeaux.fr   
Principal Investigator: Noel MILPIED, Pr         
Centre Hospitalier de la Région d'Annecy Not yet recruiting
Pringy, France, 74370
Contact: Bernadette CORRONT    0033 4 50 63 66 08    bcorront@ch-annecy.fr   
Principal Investigator: Bernadette CORRONT, Dr         
CHU Robert Debré Not yet recruiting
Reims, France, 51092
Contact: Alain DELMER    0033 3 26 78 36 44    adelmer@chu-reims.fr   
Principal Investigator: Alain DELMER, Pr         
CHU Pontchaillou Not yet recruiting
Rennes, France, 35003
Contact: Thierry LAMY    0033 2 99 28 42 92    thierry.lamy.de.la.chapelle@chu-rennes.fr   
Principal Investigator: Thierry LAMY, Pr         
Centre Henri Becquerel Not yet recruiting
Rouen, France, 76038
Contact: Hervé TILLY    0033 2 32 08 22 02    herve.tilly@chb.unicancer.fr   
Principal Investigator: Hervé TILLY, Pr         
Centre René Huguenin Not yet recruiting
Saint Cloud, France, 92210
Contact: Carole SOUSSAIN    0033 1 47 11 15 36    carole.soussain@curie.net   
Principal Investigator: Carole SOUSSAIN, Dr         
CHU Brabois Not yet recruiting
Vandoeuvre les Nancy, France, 54511
Contact: Serge BOLOGNA    0033 3 83 15 32 82    s.bologna@chu-nancy.fr   
Principal Investigator: Serge BOLOGNA, Dr         
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Investigators
Principal Investigator: Corinne HAIOUN Lymphoma Study Association
  More Information

No publications provided

Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT01553786     History of Changes
Other Study ID Numbers: REVAIL
Study First Received: January 20, 2012
Last Updated: April 15, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on July 22, 2014