An open label, multicenter, non randomized phase II study to evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with Rituximab (MabThera®) in patients with follicular non Hodgkin’s lymphoma with no prior treatment - FL2008 RGM
- Conditions
- 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: 9.1Level: LLTClassification code 10025310Term: Lymphoma
- Registration Number
- EUCTR2007-005580-95-FR
- Lead Sponsor
- Goelams
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•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 < 2 on the ECOG scale (see appendix 7).
•Stage II, III or IV (Ann Arbor)
•Must have disease measurable in at least 2 dimensions either clinically or radiologically
•Low tumor burden according to the GELF criteria: none of the following criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>•To evaluate overall survival (OS) <br>•To evaluate the duration of response (DR)<br>•To evaluate Time to next treatment (TTNT)<br>•To evaluate the safety profile of GM-CSF-Rituximab association<br>•evaluate Fc?Rs polymorphisms influence on clinical response<br>•To monitor Fc?Rs expressing cells in peripheral blood along the treatment<br>•To monitor the molecular biological marker bcl2 (translocation t(14;18) in peripheral blood and bone marrow (PCR assay) <br>;Primary end point(s): •Overall response rate (including CR and PR) after induction as defined by international criteria (Cheson et al. 1999) (Appendix 4)
- Secondary Outcome Measures
Name Time Method