This study evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with Rituximab (MabThera®) 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: mabthera
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: MABTHERA
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 100mg/
Sponsors
Goelams
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histologicaly confirmed follicular lymphoma grade 1, 2 or 3a, (see appendix 4) with material available for central review (appendix 8). •Not previously treated. •Age must be > 18 years. •Having signed a written informed consent •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” FL). •Grade 3b follicular lymphoma. •Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningiosis). •Patients regularly taking corticosteroids during the last 4 weeks. •Patients with prior or concomitant malignancies except non-melanomatous skin cancer or adequately treated in situ cervical cancer. •Major surgery (excluding lymph node biopsy) within 28 days prior to registration. •Poor renal function: Serum creatinin > 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •evaluate the clinical efficacy of GM-CSF associated with Rituximab (overall objective complete and partial response rates) in patients with follicular lymphoma with no prior treatment;Secondary Objective: •To evaluate time to progression (TTP) •To evaluate overall survival (OS) •To evaluate the duration of response (DR) •To evaluate Time to next treatment (TTNT) •To evaluate the safety profile of GM-CSF-Rituximab association •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 bcl2 (translocation t(14;18) in peripheral blood and bone marrow (PCR assay) ;Primary end point(s): •Overall response rate (including CR and PR) after induction as defined by international criteria (Cheson et al. 1999) (Appendix 4) | — |
Countries
France
Outcome results
None listed