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

July 23, 2021 updated by: The Lymphoma Academic Research Organisation

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)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: lenalidomide
lenalidomide + CHOP
Drug: Lenalidomide
Lenalidomide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Complete response rate
Time Frame: maximum 60 days after last study drug intake
maximum 60 days after last study drug intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Lymphoma Academic Research Organisation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Corinne HAIOUN, Lymphoma Study Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REVAIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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