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

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ClinicalTrials.gov Identifier: NCT01553786
Recruitment Status : Active, not recruiting
First Posted : March 14, 2012
Last Update Posted : October 12, 2018
Sponsor:
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)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : November 2011
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : March 2020


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

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 ClinicalTrials.gov identifier (NCT number): NCT01553786


Locations
Belgium
Université Catholique de Louvain Saint Luc
Bruxelles, Belgium, 1200
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Université Catholique de Louvain Mont Godinne
Yvoir, Belgium, 5530
France
CHU d'Amiens - Hôpital Sud
Amiens, France, 80054
CHU Angers
Angers, France, 49033
CH d'Avignon - Hôpital Henri Duffaut
Avignon, France, 84902
CHU Jean Minjoz
Besançon, France, 25030
Institut Bergonié
Bordeaux, France, 33076
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33077
Centre hospitalier Chalon sur Saone William Morey
Châlon sur saône, France, 71100
CHU Estaing
Clermont Ferrand, France, 63000
CH Sud Francilien de Corbeil
Corbeil Essonnes, France, 91106
Hôpital Henri Mondor
Créteil, France, 94010
CHU de Dijon
Dijon, France, 21000
CHU de Grenoble
Grenoble, France, 38043
CH Départemental
La roche sur Yon, France, 85925
CHRU de Lille
Lille, France, 59037
Institut Paoli Calmette
Marseille, France, 13273
Centre Hospitalier de Meaux
Meaux, France, 77104
CHU Saint-Eloi
Montpellier, France, 34295
CHU Hôtel Dieu
Nantes, France, 44093
Hôpital Saint Louis
Paris, France, 75475
Hôpital Necker
Paris, France, 75743
Centre Francois Magendie
Pessac, France, 33604
CHU Lyon Sud
Pierre Bénite, France
Centre Hospitalier de la Région d'Annecy
Pringy, France, 74370
CHU Robert Debré
Reims, France, 51092
CHU Pontchaillou
Rennes, France, 35003
Centre Henri Becquerel
Rouen, France, 76038
CHU Brabois
Vandoeuvre les Nancy, France, 54511
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Investigators
Principal Investigator: Corinne HAIOUN Lymphoma Study Association

Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT01553786     History of Changes
Other Study ID Numbers: REVAIL
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphadenopathy
Lenalidomide
Thalidomide
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