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Follicular LymphomaPhase 2R2-CHOP2NCT01393756

Revlimid Dose 25 mg in Association With (R-CHOP) in the Treatment Follicular Lymphoma

A Phase 2 study testing Lenalidomide and R-CHOP in people with Follicular Lymphoma, run by The Lymphoma Academic Research Organisation at 24 sites in France.

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

The purpose of the study is to assess the efficacy of the association of Lenalidomide (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone) in a population of patients with follicular lymphoma as measured by the response rate at the end of treatment. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Follicular Lymphoma
What is being tested?
Lenalidomide and R-CHOP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
24 sitesFrance
Study dates
Dec 2010to Nov 2015
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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients with follicular lymphoma, (WHO) grade 1, 2 or 3a with at least one of the following signs requiring initiation of treatment:
  • Bulky disease according to the GELF criteria: nodal or extra-nodal mass >7cm in its greater diameter
  • B symptoms
  • Elevated serum (LDH) or beta 2-microglobulin
  • Involvement of at least 3 nodal sites (each >3cm)
  • Symptomatic spleen enlargement
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  • Compressive syndrome
  • Pleural or peritoneal effusion
  • Aged from 18 to 70 years
  • WHO performance status 0, 1 or 2
  • Signed inform consent
  • Life expectancy of ≥ 90 days (3 months).
  • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL not more than 3 days from the start of study drug and must either commit to continued abstinence from heterosexual intercourse (and confirmed on a monthly basis) or begin one effective method of birth control, at least four weeks before she starts taking lenalidomide, and maintain that method throughout the entire duration of study drug therapy (including dose interruptions), and for four weeks after the end of study treatment with lenalidomide, even if she has amenorrhea. FCBP must also agree to pregnancy testing at least every three weeks and must be counseled at a minimum of every three weeks about pregnancy precautions and risks of fetal exposure.
  • Men must agree not to father a child and agree to use a condom throughout study drug therapy, during any dose interruption, and for one week after cessation of study drug therapy, if their partner is pregnant or of child bearing potential. Men must also agree not to donate semen during study drug therapy and for one week after end of study drug therapy. Men must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
  • All subjects must abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
  • Agree not to share study drug with another person and to return all unused study drug to the investigator.
  • A female patient is considered to have childbearing potential unless she meets at least one of the following criteria 1) Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential); or 2) Premature ovarian failure confirmed by a specialist gynaecologist or 3) Previous bilateral salpingo-oophorectomy (BSO), or hysterectomy, or 4) XY genotype, turner syndrome, uterine agenesis.

Who cannot join

  • Previous treatment with immunotherapy or chemotherapy:
  • Chlorambucil or Cyclophosphamide per os alone during less than 6 months, if stopped more than one year before inclusion
  • Rituximab alone during less than three months, if stopped more than one year before inclusion
  • Previous radiotherapy except if localized to one lymph node area
  • Other type of lymphomas: Burkitt, T cell, lymphocytic, CD 20 negative
  • Central nervous system or meningeal involvement
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  • Contraindication to any drug contained in the chemotherapy regimen
  • (HIV) disease, active hepatitis B or C
  • Any serious active disease or co-morbid medical condition (according to investigator's decision)
  • Any of the following laboratory abnormalities.
  • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
  • Platelet count < 100,000/mm3 (100 x 109/L).
  • Serum (SGOT/AST) or (SGPT/ALT) 5.0 x upper limit of normal (ULN).
  • Serum total bilirubin > 2.0 mg/dL (34 µmol/L), except in case of hemolytic anemia.
  • Calculated creatinine clearance (Cockcroft-Gault formula) of < 50 mL /min
  • Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or lactating females.
  • Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide.
  • Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
  • Subjects with ≥ Grade 2 neuropathy.
  • Prior use of lenalidomide.
  • Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • Institut Bergonié

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077

  • CHU Estaing

    Clermont-Ferrand, 63000

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU de DIJON

    Dijon, 21034

  • Chru Lille

    Lille, 59037

  • Centre Léon Bérard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13273

  • Hôpital Notre Dame de Bon Secours

    Metz, 57038

  • Hôpital Saint Eloi

    Montpellier, 34295

  • CHU de NANTES

    Nantes, 44093

  • Hôpital Saint Antoine

    Paris, 75012

  • Hôpital de la Pitié Salpétrière

    Paris, 75013

  • Hôpital Necker

    Paris, 75015

  • Institut Curie

    Paris, 75231

  • Hôpital St Louis

    Paris, 75475

  • Chu Lyon Sud

    Pierre-Bénite, 69310

  • CHU de Poitiers

    Poitiers, 86021

  • Hôpital Robert Debré

    Reims, 51092

  • Hôpital Pontchaillou

    Rennes, 35033

  • Centre Henri BECQUEREL

    Rouen, 76038

  • Hôpital René Huguenin

    Saint-Cloud, 92211

  • Chu Brabois

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Phase Ib/II Study of Escalating Doses of Revlimid in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma

The purpose of the study is to assess the efficacy of the association of Lenalidomide (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone) in a population of patients with follicular lymphoma as measured by the response rate at the end of treatment.

Being tested
Lenalidomide and R-CHOP
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • Lenalidomide and R-CHOPDrug

    Also called R2-CHOP2

    Lenalidomide dose administered orally during 14 days in combination with 6 courses of fixed doses of R-CHOP 21.

Study groups in NCT01393756
Study groupRoleWhat they receive
Lenalidomide dose 25 mgExperimentalNot described
Receives: Drug: Lenalidomide and R-CHOP

What is being measured

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

  1. Complete Response Rate (CR+CRu)

    Measured: at the end of complete treatment, average of 24 weeks

Secondary outcomes (2)

  1. Overall survival

    Measured: from the date of inclusion, average of 6 years

  2. Duration of response

    Measured: from the date of first documentation of a response, average of 24 weeks

Timeline

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

  1. First posted13 Jul 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionJul 2013
  4. Study completionNov 2015

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
NCT01393756
Sponsor's protocol ID
R2-CHOP2
Acronym
R2-CHOP2
Status last verified
Dec 2023
First submitted
4 Jul 2011
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Tilly H, Morschhauser F, Casasnovas O, Molina TJ, Feugier P, Gouill SL, Haioun C, Tournilhac O, Bouabdallah R, Gabarre J, Lamy T, Cabecadas J, Becker S, Jardin F, Mounier N, Salles G; Lymphoma Study Association. Lenalidomide in combination with R-CHOP (R2-CHOP) as first-line treatment of patients with high tumour burden follicular lymphoma: a single-arm, open-label, phase 2 study. Lancet Haematol. 2018 Sep;5(9):e403-e410. doi: 10.1016/S2352-3026(18)30131-5.

    PubMed 30172345

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide and R-CHOP in people with Follicular Lymphoma, run by The Lymphoma Academic Research Organisation at 24 sites in France.

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 17 inclusion and 23 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France. 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 (CR+CRu) (time frame: at the end of complete treatment, average of 24 weeks). 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 NCT01393756, 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 5 Dec 2023.

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