Follicular, CD20-Positive B-Cell Non-Hodgkin's Lymphoma MedDRA version: 9.1 Level: LLT Classification code 10029593 Term: Non-Hodgkin's lymphoma NOS
Conditions
Interventions
Product Name: Apomab
Pharmaceutical Form: Intravenous infusion
Trade Name: MabThera
Product Name: Mabthera
Pharmaceutical Form: Intravenous infusion
Sponsors
Genentech Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: >Signed Informed Consent Form > Age =18 years >Diagnosis of follicular, CD20-positive B-cell NHL classified as Grade 1, 2, or 3a according to the WHO classification of malignant lymphomas >Progression of disease after an objective response (CR/CRu or PR) or SD according to revised IWG criteria lasting 6 months following completion of the most recent rituximab-containing regimen >A rituximab-containing regimen is defined as rituximab as a single agent during induction and/or maintenance, or in combination with other agents. >Measurable disease (according to modified IWG Criteria; see Appendix B) ECOG performance status of 0 or 1 (see Appendix D) >Life expectancy of 3 months >Willingness and capability to be accessible for follow-up until study termination or death >For patients of reproductive potential (both males and females), use of a reliable means of contraception (e.g., contraceptive pill, intrauterine device [IUD], barrier methods) throughout the trial and for 1 year following their last exposure to study 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: >Grade 3b follicular lymphoma (according to the WHO classification) or histologic transformation from follicular lymphoma to aggressive lymphoma >Prior radiotherapy to a lesion(s) that will be used to assess response unless that lesion(s) shows clear evidence of lymphoma progression at baseline (i.e., =50% increase in the product of the longest perpendicular diameters of the lesion [greatest transverse diameter perpendicular diameter] when compared with the nadir of lesion dimensions following radiotherapy and 1.5 cm in the greatest transverse diameter) >Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1 or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1 > Patients who received prior radio-immunotherapy for relapsed or refractory follicular NHL at least 1 year prior to first administration of study drug (i.e, rituximab) may participate if they meet minimal study requirements for peripheral blood counts (see below) and do not demonstrate evidence of myelodyplastic syndrome (MDS) on their screening bone marrow biopsy (as evidenced by cytogenetic or FISH criteria). >Concurrent systemic corticosteroid therapy (except low-dose corticosteroid therapy used to treat an illness other than lymphoma or single dose of up to 100mg hydrocortisone, administered as prophylaxis against rituximab-mediated infusion reactions) >Other invasive malignancies within 3 years prior to first study drug administration (i.e, rituximab) except for adequately treated (with curative intent) basal or squamous cell skin cancer,in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, limited-stage bladder cancer, or other cancers from which the patient has been disease-free for at least three years. >History or evidence on physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, CNS lymphoma, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke) >Prior treatment with agonistic DR4 or DR5 antibodies or Apo2L/TRAIL >General Medical Concerns >Current or recent (within the 28 days prior to Cycle 1, Day 1) participation in another experimental drug study >Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction within 1 year prior to Cycle 1, Day 1, unstable angina), New York Heart Association (NYHA; see Appendix E) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication within 1 year prior to Cycle1, Day 1, or Grade II or greater peripheral vascular disease (see Appendix F) at study entry >Active infection requiring parenteral antibiotics on Cycle 1, Day 1 Protocol: Apomab—Genentech, >Major surgical procedure (excluding lymph node biopsy) or significant traumatic injury within 28 days prior to Cycle 1, Day 1, or anticipation of need for major surgical procedure during the course of the study >Pregnancy (positive pregnancy test) or breast feeding >Serious, non-healing wound, ulcer, or bone fracture Laboratory values ANC 1500/L (may not be treated with G-CSF to maintain or exceed this level) Platelet count 75,000/L Total bilirubin1.6 mg/dL AST or ALT 2.5 the upper limit of normal (ULN) Serum creatinine 2.0 mg/dL or measured creatinine clearance =50 mL/min Hemoglobin 9 g/dL (may not be transfused or treated with erythropoietin to maintain or exceed this level) >Known human immunodeficiency virus (HIV) infection, seropositivit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of Apomab when combined with rituximab for the treatment of patients with relapsed follicular, CD20-positive B-cell non-Hodgkin’s lymphoma (NHL). To make a preliminary assessment of the efficacy of Apomab when combined with rituximab for the treatment of patients with relapsed follicular, CD20-positive B-cell NHL, as measured byobjective response rate. ;Secondary Objective: To make a preliminary assessment of the efficacy of Apomab when combined with rituximab for the treatment of patients with relapsed follicular, CD20-positive B-cell NHL, as measured by progression-free survival, duration of response, and overall survival. To evaluate the serum pharmacokinetics of Apomab and rituximab when combined for the treatment of patients with relapsed follicular, CD20-positive B-cell NHL.;Primary end point(s): Objective response (defined as a PR or CR/CRu, occurring within 8 months after Cycle 1, Day 1), as determined by the IRF using modified IWG Criteria | — |
Countries
Belgium, Netherlands, Spain, United Kingdom
Outcome results
None listed