This study evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with Rituximab (MabThera®) and chemotherapy (CHOP) in patients with non bulky follicular non Hodgkin’s lymphoma with no prior treatment. MedDRA version: 9.1 Level: LLT Classification code 10025310 Term: Lymphoma
Conditions
Interventions
Trade Name: leukine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Leukine
Concentration unit: µg/kg microgram(s)/kilogram
Concentration type: equal
Concentration number: 250-
Sponsors
Goelams
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histologically confirmed follicular lymphoma grade 1, 2 or 3a (biopsy = 4 months). •Patients previously untreated (including treatments with steroids and radiation therapy) •Bulky disease at study entry according to the GELF criteria: Nodal or extranodal mass > 7cm in its greater diameter Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm) B symptoms Elevated serum LDH or ß2-microglobulin Splenic enlargement Compressive syndrome Pleural/peritoneal effusion •Age must be > 18 years. •Performance status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Transformation to high-grade lymphoma (secondary to “low-grade” follicular lymphoma). •Grade 3b follicular lymphoma. •Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis). •Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to 2.0 mg/dL (197 µmol/L), •Poor hepatic function: total bilirubin > 2.0 mg/dL (34 µmol/L), AST (SGOT) > 3 x the upper limit of normal unless these abnormalities are related to lymphoma. •Known HIV infection or active HBV or HCV infection = 4 weeks at registration. •Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease, heart failure). Judgment is up to the investigator. •Life expectancy < 6 months •Known sensitivity or allergy to murine products •Treatment within a clinical trial within 30 days prior to trial entry •Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the overall tumor response rate of GM-CSF associated with RCHOP (overall objective complete and partial response rates) in patients with follicular lymphoma with no prior treatment ;Primary end point(s): •Overall response rate (including CR and PR) after induction as defined by international criteria ([1] Appendix 0 page 39);Secondary Objective: •To evaluate time to progression (TTP) •To evaluate overall survival (OS) •To evaluate the duration of response (DR) •Time to next treatment (TTNT) •To evaluate the safety profile of GM-CSF in association with RCHOP chemotherapy •To evaluate Fc?Rs polymorphisms influence on clinical response •To monitor Fc?Rs expressing cells in peripheral blood along the treatment •To monitor the molecular biological marker bcl-2 (translocation t(14;18) in peripheral blood and bone marrow (quantitative PCR assay) | — |
Countries
France
Outcome results
None listed