DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Lenalidomide and R-CHOP in B-cell Lymphoma

Information source: Lymphoma Study Association
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma, Large B-Cell, Diffuse; Follicular Lymphoma; Mantle Cell Lymphoma; Marginal Zone B-Cell Lymphoma

Intervention: Lenalidomide and R-CHOP (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Lymphoma Study Association

Official(s) and/or principal investigator(s):
Hervé TILLY, Prof, Principal Investigator, Affiliation: Lymphoma Study Association

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).

Clinical Details

Official title: A Phase IB Study of Escalating Doses of REVLIMID in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of Dose Limiting Toxicities

Secondary outcome:

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

Complete and Overall response rates after induction

Progression-Free Survival and Overall survival

Duration of response

Collection of adverse events

Detailed description: The study is a dose escalation study of lenalidomide (Revlimid) administered orally during 14 days in combination with fixed doses of rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks (R-CHOP 21) in patients with B-cell lymphoma.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. Exclusion Criteria:

- Previous treatment with immunotherapy or chemotherapy except:

- 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.

Locations and Contacts

CHU de Dijon, Dijon 21034, France

CHRU Lille, Lille 59037, France

CHU Lyon Sud, Pierre Benite 69310, France

Centre Henri Becquerel, Rouen 76038, France

CHU Brabois, Vandoeuvre les Nancy 54511, France

Additional Information

GELA

Starting date: January 2009
Last updated: March 3, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017