A Phase III, Multicenter, Open-Label, Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination with CHOP (G-CHOP) Versus Rituximab and CHOP (RCHOP)in Previously Untreated Patients with CD20-Positive Diffuse Large B-Cell Lymphoma(DLBCL) - GOYA
- Conditions
- PREVIOUSLY UNTREATED PATIENTS WITH CD20-POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA DLBCL)MedDRA version: 14.0Level: HLTClassification code 10012819Term: Diffuse large B-cell lymphomasSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-024194-39-IT
- Lead Sponsor
- F. Hoffmann - La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1414
Written informed consent • Previously untreated CD20-positive DLBCL histologically documented using the following: The pathology report must be available for review and a tissue block sent for retrospective central confirmation. Formalin-fixed paraffin-embedded tissue blocks are preferred; however, in countries using a different fixative, any tissue block available will be accepted and notation of the type of fixative included. If a tissue block is not available, 15 unstained slides will be accepted. The optional RCR sample and required exploratory biomarker samples will be obtained from the same tissue block. If central confirmation is unableto be performed on submitted material, stained slides used for diagnosis may also be requested. IPI disease risk score that is one of the following: low-intermediate, high-intermediate, or high risk (see Appendix F) Patients at low disease risk according to the IPI are eligible if they have bulky disease (one lesion = 7.5 cm). • At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its largest dimension on CT scan • Ability and willingness to comply with the study protocol procedures • Age = 18 years • ECOG performance status of 0, 1, or 2 (see Appendix G) • LVEF = 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram • Adequate hematologic function, defined as follows: Hemoglobin = 9 g/dL Absolute neutrophil count = 1.5 × 109/L Platelet count = 75 × 109/L • For men who are not surgically sterile: agreement to use a barrier method of contraception during the treatment period and until = 3 months after the last dose of GA101 or rituximab, or according to institutional guidelines for CHOP chemotherapy, whichever is longer, and agreement to request that their partners use an additional method of contraception, such as oral contraceptives, intrauterine device, barrier method, or spermicidal jelly • For women of reproductive potential who are not surgically sterile: agreement to use two adequate methods of contraception, such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly during the treatment period and until = 12 months after the last dose of GA101 or rituximab, or according to institutional guidelines for CHOP chemotherapy, whichever is longer
Are the trial subjects under 18?
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 910
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 490
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products • Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines; Diagnosis of transformed lymphoma (follicular IIIB) if previously treated withradiotherapy,chemotherapy or immunotherapy • Prior therapy for DLBCL,with the exception of nodal biopsy or local irradiation • Prior treatment with cytotoxic drugs or rituximab for another condition (e.g.rheumatoid arthritis) or prior use of an anti-CD20 antibody • Prior use of any monoclonal antibody within 3 months of the start of Cycle 1 • Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent Pts receiving corticosteroid treatment with = 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks duration prior to randomization (Cycle 1, Day 1). • Primary CNS lymphoma,blastic variant of MCL,or histologic evidence of transformation to a Burkitt lymphoma,primary mediastinal DLBCL,primary effusion lymphoma and primary cutaneous DLBCL • Vaccination with live vaccines within 28 days prior to randomization • Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1 • History of other malignancy that could affect compliance with the protocol or interpretation of results Pts with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible.Pts with a malignancy that has been treated but not with curativeintent will also be excluded, unless the malignancy has been in remission without treatment for = 5 years prior to enrollment. • Evidence of significant,uncontrolled concomitant diseases that 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 bronchospasm) • Recent major surgery (within 4 weeks prior to the start of Cycle 1)other than for diagnosis Any of the following abnormal laboratory values: Creatinine > 1.5 times the upper limit of normal (ULN) (unless creatinine clearance normal), or calculated creatinine clearance < 40 mL/min (using the Cockcroft–Gault formula; see Appendix H) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × the ULN Total bilirubin = 1.5 × the ULN: Patients with documented Gilbert disease may be enrolled if total bilirubin is = 3.0 × the ULN. International normalized ratio (INR) > 1.5 × the ULN in the absence of therapeutic anticoagulation Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) > 1.5 × the ULN in the absence of a lupus anticoagulant • Positive test results for chronic hepatitis B infection (defined as positive HBsAg serology) A maximum of 100 patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to undergo monthly DNA testing. Positive test results for hepatitis C (hepatitis C virus antibody serology testing) Patients positive for HCV antibody are eligible only if PCR is negative fo
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method