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

NCT01393756 | Completed Phase 2 DMC

• 1 other identifier: R2-CHOP2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CR+CRu)

  at the end of complete treatment, average of 24 weeks

Secondary Outcomes (2)

• Overall survival

  from the date of inclusion, average of 6 years

• Duration of response

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

Study Arms (1)

Lenalidomide dose 25 mg

EXPERIMENTAL

Drug: Lenalidomide and R-CHOP

Interventions

Lenalidomide and R-CHOP DRUG

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

Also known as: R2-CHOP2

Lenalidomide dose 25 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Previous treatment with immunotherapy or chemotherapy:
• 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
• 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.

Sponsors & Collaborators

• The Lymphoma Academic Research Organisation: lead
• Centre Henri Becquerel: collaborator

Study Sites (24)

Institut Bergonié

Bordeaux, 33076, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33077, France

Location

CHU Estaing

Clermont-Ferrand, 63000, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU de DIJON

Dijon, 21034, France

Location

Chru Lille

Lille, 59037, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Hôpital Notre Dame de Bon Secours

Metz, 57038, France

Location

Hôpital Saint Eloi

Montpellier, 34295, France

Location

CHU de NANTES

Nantes, 44093, France

Location

Hôpital Saint Antoine

Paris, 75012, France

Location

Hôpital de la Pitié Salpétrière

Paris, 75013, France

Location

Hôpital Necker

Paris, 75015, France

Location

Institut Curie

Paris, 75231, France

Location

Hôpital St Louis

Paris, 75475, France

Location

Chu Lyon Sud

Pierre-Bénite, 69310, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Hôpital Robert Debré

Reims, 51092, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre Henri BECQUEREL

Rouen, 76038, France

Location

Hôpital René Huguenin

Saint-Cloud, 92211, France

Location

Chu Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

• 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.

  PMID: 30172345 DERIVED

Related Links

• Lymphoma Study Association LYSA

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hervé TILLY, Professeur

  Lymphoma Study Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2011
• First Posted: July 13, 2011
• Study Start: December 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: November 1, 2015
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (24)