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T-cell LymphomaPhase 2NCT01553786

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

A Phase 2 study testing Lenalidomide in people with T-cell Lymphoma, run by The Lymphoma Academic Research Organisation at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
T-cell Lymphoma
What is being tested?
Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
30 sitesin 2 countries
Study dates
Nov 2011to 21 Mar 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

France27 sites

  • CHU d'Amiens - Hôpital Sud

    Amiens, 80054

  • CHU Angers

    Angers, 49033

  • CH d'Avignon - Hôpital Henri Duffaut

    Avignon, 84902

  • CHU Jean Minjoz

    Besançon, 25030

  • Institut Bergonié

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077

  • Centre hospitalier Chalon sur Saone William Morey

    Châlon Sur Saône, 71100

  • CHU Estaing

    Clermont-Ferrand, 63000

  • CH Sud Francilien de Corbeil

    Corbeil-Essonnes, 91106

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU de Dijon

    Dijon, 21000

  • CHU de Grenoble

    Grenoble, 38043

  • CH Départemental

    La Roche-sur-Yon, 85925

  • CHRU de Lille

    Lille, 59037

  • Institut Paoli Calmette

    Marseille, 13273

  • Centre Hospitalier de Meaux

    Meaux, 77104

  • CHU Saint-Eloi

    Montpellier, 34295

  • CHU Hôtel Dieu

    Nantes, 44093

  • Hôpital Saint Louis

    Paris, 75475

  • Hôpital Necker

    Paris, 75743

  • Centre Francois Magendie

    Pessac, 33604

  • CHU Lyon Sud

    Pierre-Bénite

  • Centre Hospitalier de la Région d'Annecy

    Pringy, 74370

  • CHU Robert Debré

    Reims, 51092

  • CHU Pontchaillou

    Rennes, 35003

  • Centre Henri Becquerel

    Rouen, 76038

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Belgium3 sites

  • Université Catholique de Louvain Saint Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Université Catholique de Louvain Mont Godinne

    Yvoir, 5530

Other trials in Belgium

About this study

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)

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.

Conditions
T-cell Lymphoma
Being tested
Lenalidomide
Keywords
T-cell lymphoma, CHOp, lenalidomide
Medical subject headings
Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01553786
Study groupRoleWhat they receive
lenalidomideExperimentallenalidomide + CHOP
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate

    Measured: maximum 60 days after last study drug intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionMar 2018
  4. Study completion21 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01553786
Sponsor's protocol ID
REVAIL
Status last verified
Jul 2021
First submitted
20 Jan 2012
Last updated
26 Jul 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Lemonnier F, Safar V, Beldi-Ferchiou A, Cottereau AS, Bachy E, Cartron G, Fataccioli V, Pelletier L, Robe C, Letourneau A, Missiaglia E, Fourati S, Moles-Moreau MP, Delmer A, Bouabdallah R, Voillat L, Becker S, Bossard C, Parrens M, Casasnovas O, Cacheux V, Regny C, Camus V, Delfau-Larue MH, Meignan M, de Leval L, Gaulard P, Haioun C. Integrative analysis of a phase 2 trial combining lenalidomide with CHOP in angioimmunoblastic T-cell lymphoma. Blood Adv. 2021 Jan 26;5(2):539-548. doi: 10.1182/bloodadvances.2020003081.

    PubMed 33496747

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide in people with T-cell Lymphoma, run by The Lymphoma Academic Research Organisation at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (time frame: maximum 60 days after last study drug intake). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01553786, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.

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