follicular non-Hodgkin’s lymphoma (NHL)
Conditions
Interventions
Product Name: rhuMAb 2H7
Product Code: Ro496-4913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: RO4964913
Other descriptive
Sponsors
Roche Products Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able and willing to provide written informed consent and to comply with the study protocol. 2. Age > or equal to18 years. 3. History of histologically confirmed CD20+, follicular NHL (any grade) according to the WHO classification system (WHO 2002; Appendix 2D). 4. Histopathology will be reviewed at the study site to confirm diagnosis. CD20 expression will be assessed at the study site according to local standard procedures. 5. Documented history of a response (CR/CRu/PR >6 months) or SD of >6 months duration to a prior rituximab-containing regimen that was the last treatment given prior to enrolment. There is no limit to the number of prior chemotherapy or rituximab regimens. Patients may be refractory to prior chemotherapy but must have responded to the last rituximab containing regimen as defined above. 6. At least one bidimensionally measurable lesion (> or = to 1.5 cm in its largest dimension by computerized tomography [CT] scan). Note that all measurable and evaluable disease must be assessed and documented prior to initiation of treatment. Tumor response will be based on the status of all areas of disease. 7. ECOG performance status of 0 or 1. 8. Life expectancy > or = to 6 months. 9. No evidence of acute or chronic hepatitis B virus [HBV] or hepatitis C virus [HCV] infection 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: 1. Prior use of any monoclonal antibody therapy other than rituximab, or any anti-cancer vaccine, or any radioimmunotherapy for cancer. 2. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Known sensitivity or allergy to murine products. 3. Central nervous system lymphoma or histological evidence of transformation to high grade or diffuse large B-cell lymphoma. 4. History of malignancy other than follicular NHL which could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible. 5. Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of symptomatic bronchospasm). 6. Known active bacterial, viral (including human immunodeficiency virus [HIV]), fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening. 7. Recent major surgery (within 4 weeks prior to screening), other than for diagnosis. 8. Any of the following abnormal laboratory values: • Serum creatinine > 2 mg/dL. • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal. • Platelet count <75 x 10exp 9/L. • Neutrophils <1.5 x 10exp9/L. 9. Pregnancy or lactation. 10. Fertile men or women of childbearing potential unless (1) surgically sterile or (2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly. Effective contraception is required throughout the study and (because of the long half-life of humanized monoclonal antibodies and the potential for prolonged lymphopenia) for at least 12 months after the last dose of rhuMAb 2H7. 11. Treatment within a clinical study within 30 days prior to trial entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study is to evaluate the safety and tolerability of escalating intravenous (IV) doses of 3-weekly rhuMAb 2H7 in patients with CD20+, follicular NHL whose disease has progressed after prior rituximab containing therapy;Secondary Objective: • To characterize the pharmacokinetics of rhuMAb 2H7 in patients with follicular NHL • To examine peripheral blood B-cell depletion with increasing doses of rhuMAb 2H7 • To obtain preliminary data on the anti-tumor efficacy of rhuMAb 2H7 by evaluating - overall response rate - progression-free survival - event-free survival • To explore pharmacogenetic parameters (notably FcgammaR IIa and IIIa polymorphisms at baseline) and a pharmacodynamic parameter (notably bcl-2 rearrangements at baseline, during and after treatment) in relation to efficacy. ;Primary end point(s): The primary safety endpoint will be the incidence of dose limiting toxicities (DLTs). The definition of the DLT is given in the protocol under section 3.1.1. | — |
Countries
Sweden
Outcome results
None listed