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

Follicular Lymphoma Clinical Trial

— R2-CHOP2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393756
• Other study ID #: R2-CHOP2
• Status: Completed
• Phase: Phase 2
• Start date: December 2010
• Est. completion date: November 2015

Study information

• Verified date: December 2023
• Source: The Lymphoma Academic Research Organisation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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

• 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.

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

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

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	CHU Estaing	Clermont ferrand
France	Hôpital Henri Mondor	Creteil
France	CHU de DIJON	Dijon
France	Chru Lille	Lille
France	Centre Léon Bérard	Lyon
France	Institut Paoli Calmettes	Marseille
France	Hôpital Notre Dame de Bon Secours	Metz
France	Hôpital Saint Eloi	Montpellier
France	CHU de NANTES	Nantes
France	Hôpital de la Pitié Salpétrière	Paris
France	Hôpital Necker	Paris
France	Hôpital Saint Antoine	Paris
France	Hôpital St Louis	Paris
France	Institut Curie	Paris
France	Chu Lyon Sud	Pierre-benite
France	CHU de Poitiers	Poitiers
France	Hôpital Robert Debré	Reims
France	Hôpital Pontchaillou	Rennes
France	Centre Henri BECQUEREL	Rouen
France	Hôpital René Huguenin	Saint-Cloud
France	Chu Brabois	Vandoeuvre-les-nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
The Lymphoma Academic Research Organisation	Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate (CR+CRu)		at the end of complete treatment, average of 24 weeks
Secondary	Overall survival		from the date of inclusion, average of 6 years
Secondary	Duration of response		from the date of first documentation of a response, average of 24 weeks

External Links

•   Lymphoma Study Association LYSA