Patients with advanced follicular lymphoma after induction of response (CR(u) or PR) with a MabThera® (rituximab)-containing first line regimen MedDRA version: 7.1 Level: PT Classification code 10061170
Conditions
Interventions
Trade Name: MabThera
Product Name: MabThera
Product Code: RO0452294
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: rituximab
CAS Number: 174722-31
Current Sponsor code: RO0452294
Conc
Sponsors
Roche (Magyarország) Kft
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Signed an IRB- approved written informed consent. b. Histologically confirmed follicular lymphoma grade 1, 2, or 3a (see Appendix C) with a lymph node biopsy performed within 4 months before the induction treatment and with material available for eventual further review c. Documented parameters for FLIPI determination (Appendix I) before induction therapy d. No previous antilymphoma treatment received before the induction chemotherapy. (Just first line treated patients are eligible.) e. Verified complete or partial remission (CR(u) or PR) (see Appendix A) after induction (Allowed induction treatments are listed in Appendix B). Staging (see Appendix C) must be started 4 weeks after the last MabThera® infusion in the induction scheme and must be completed 2 weeks before baseline. The maximum allowed period between the last infusion of the induction and first infusion of MabThera® maintenance therapy is 8 weeks. Eligible first line induction regimens before staging (Appendix B): i. MabThera® plus CVP chemotherapy (R-CVP), containing 8 cycles of CVP given together with 8 cycles of MabThera® ii. MabThera® plus CHOP chemotherapy (R-CHOP), containing 6-8 cycles of CHOP given together with 8 cycles of MabThera®. iii. 2 cycle of R-CVP followed by 6 cycle of R-CHOP. If the treatment of patient started by R-CVP, and the response after 2 cycle of R-CVP was unsatisfactory by the judgement of physician, the treatment can be continued by 6 cycles of R-CHOP f. Males or females, older than 18 years g. Expected survival > 4 months. h. Prestudy performance status ECOG 0, 1 or 2 (see Appendix D) i. Acceptable hematological status within two weeks prior to treatment start, including: I. Hb > 8.0 g/dL. II. WBC > 3.0 x 103/ mm3 (x 109/ L). III. Absolute granulocyte count (segmented neutrophils + bands x total WBC) >1.5 x 103/ mm3 (x 109/ L). IV. Platelet count >75 x 103/ mm3 (x 109/ L). j. Women must agree to follow accepted birth control methods during the trial. In case of men also an agreement for contraception is needed until the end of the first year after receiving the last infusion of maintenance treatment. 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
Exclusion criteria
Exclusion criteria: a. Grade 3b follicular lymphoma b. Any previous antilymphoma treatment before induction chemotherapy. (Relapsed patients) c. Patients received other induction pretreatment as specified in Appendix B d. Transformation to high grade lymphoma (except to grade 3a) of the previously existed follicular lymphoma e. Presence of CNS lymphoma. f. AIDS-related lymphoma. g. Active opportunistic or known HIV, HBV or HCV infection. h. Major surgery, other than diagnostic surgery, within 4 weeks prior to registration. i. Another primary malignancy (other than squamous cell carcinoma of the skin or in situ carcinoma of the cervix) for which the patient has not been disease-free for at least five years. j. Patients with abnormal liver function unless directly related to hepatic involvement by lymphoma. I. Total bilirubin >2.0 mg/d L (35 µmol/L). II. Alkaline phosphatase >3 x upper limit of normal range. III. AST (SGOT) >3 x upper limit of normal range. k. Patients with abnormal renal function (serum creatinine >2.0 mg/d L [177 µmol/L]). l. New York Heart Association Class III or IV heart disease (see Appendix E) or myocardial infarction within the past 6 months. m. Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to <20 mg/day prednisone for indications other than lymphoma or lymphoma-related symptoms. n. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. active uncontrolled bacterial, viral, or fungal ongoing infection(s), hydronephrosis, uncontrolled diabetes mellitus, uncontrolled gastric ulcers, active autoimmune disease). Judgment is up to the investigator. o. Sensitivity or allergy to murine products p. Treatment within a clinical trial within 30 days prior to trial entry. q. Female patients who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the benefit by determining event driven survival endpoints (EFS, PFS) of a long-term MabThera® (rituximab) maintenance therapy in patients with advanced follicular lymphoma after induction of response (CR(u) or PR) with a MabThera® (rituximab)-containing first line regimen.;Secondary Objective: Secondary objective: To describe the safety and tolerability profile of a long-term MabThera® (rituximab) maintenance therapy in patients with advanced follicular lymphoma after induction of response (CR(u) or PR) with a MabThera® (rituximab)-containing first line regimen. ;Primary end point(s): Event-free survival (EFS). EFS being defined as time from baseline to progression, relapse, death from any cause, or institution of a new antilymphoma treatment (including chemo-, radio- or immunotherapies). | — |
Countries
Hungary
Outcome results
None listed