Lenalidomide and R-CHOP in B-cell Lymphoma

NCT00901615 | Completed Phase 1 DMC

• 1 other identifier: R2CHOP-1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of the study is to determine the recommended dose (RD) of lenalidomide (Revlimid) when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone).

Conditions

Lymphoma, Large B-Cell, Diffuse; Follicular Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma

Keywords

lymphoma; lenalidomide; gela

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose Limiting Toxicities

  42 days

Secondary Outcomes (5)

• Complete response rate and Overall response rate at the end of treatment

  3 months after the end of treatment

• Complete and Overall response rates after induction

  at the end of third cycle of treatment (between Day 56 and Day 63)

• Progression-Free Survival and Overall survival

  7 years

• Duration of response

  7 years

• Collection of adverse events

  6 months

Study Arms (1)

Lenalidomide and R-CHOP

EXPERIMENTAL

Escalating Lenalidomide dose from 2.5 to 25 mg Lenalidomide and R-CHOP

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: REVLIMID

Lenalidomide and R-CHOP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with one of the following B-cell Lymphoma, CD 20 positive:
• Mantle cell, Marginal zone, follicular
• Histological transformation from low grade to high grade
• Diffuse large B cell
• 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 or begin one acceptable method of birth control, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to monthly pregnancy testing and must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
• Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Men must also be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
• † 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, or hysterectomy, or 4) XY genotype, turner syndrome, uterine agenesis.

You may not qualify if:

• Previous treatment with immunotherapy or chemotherapy except:
• 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

• Lymphoma Study Association: lead

Study Sites (5)

CHU de Dijon

Dijon, 21034, France

Location

CHRU Lille

Lille, 59037, France

Location

CHU Lyon Sud

Pierre-Bénite, 69310, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

CHU Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Links

• GELA

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; 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, Prof

  Lymphoma Study Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 14, 2009
• Study Start: January 6, 2009
• Primary Completion: November 19, 2010
• Study Completion: November 23, 2015
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

FR (5)