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

Brief Title

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

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)

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Complete response rate

Condition

T-cell Lymphoma

Intervention

Lenalidomide

Study Arms / Comparison Groups

 lenalidomide

Description:  lenalidomide + CHOP

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

80

Start Date

November 2011

Completion Date

March 21, 2019

Primary Completion Date

March 2018

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).
      

Gender

All

Ages

60 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Corinne HAIOUN, , 

Location Countries

Belgium

Location Countries

Belgium

NCT ID

NCT01553786

Organization ID

REVAIL

Responsible Party

Sponsor

Study Sponsor

The Lymphoma Academic Research Organisation

Study Sponsor

Corinne HAIOUN, Principal Investigator, Lymphoma Study Association

Verification Date

August 2019