An open label, multicenter, non randomized phase II study to evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with RCHOP chemotherapy and Rituximab (MabThera®) maintenance in patients with first-line advanced follicular non Hodgkin’s lymphoma - FL2008 RCHOPGM

Goelams0 个研究点开始时间: 2008年7月10日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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)
•Elevated serum LDH or ß2-microglobulin
•Splenic enlargement
•Compressive syndrome
•Pleural/peritoneal effusion
•Age must be > 18 years.
•Performance status < 2 on the ECOG scale (see Appendix 0 page 40).
•Adequate hematological function (unless those abnormalities are related to lymphoma extension) within 28 days prior to registration, including:
•Hemoglobin = 8.0 g/dL (5.0 mmol/L)
•Absolute neutrophil count (ANC) = 1.0x109/L
•Platelet count = 100x109/L
•Women are not breast feeding, are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. Men agree not to father a child during participation in the trial and during the 12 months thereafter.
•Patients with at least one measurable lesion
•Having previously signed a written informed consent form.
•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” 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 < 20 mg/day prednisone.
•Patients with prior or concomitant malignancies except nonmelanoma 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 creatinine > 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

发起方