A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Subjects Previously Treated With Rituximab - ND
- Conditions
- MedDRA version: 12.0Level: LLTClassification code 10059433Term: Follicular mixed small and large cell lymphoma recurrentFollicular Lymphoma
- Registration Number
- EUCTR2007-004151-11-IT
- Lead Sponsor
- JANSSEN CILAG INTERNATIONAL NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Potential subjects must satisfy the following criteria to be enrolled in the study: Male or female subjects 18 years or older Histologically proven diagnosis of follicular non-Hodgkin?s lymphoma grades 1or 2 according to the World Health Organization classification 41 Subjects must have received at least 14 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject?s medical record Documented relapse or progression following last antineoplastic treatment At least 1 measurable tumor mass (>=1.5 cm x >=1.0 cm) Eastern Cooperative Oncology Group [ECOG] performance status =<2 (Attachment 1) Absolute neutrophil count (ANC) >=1.2 x 109 cells/L Platelets >=100 x 109 cells/L (subjects should not have received platelet transfusion in the preceding 7 days) Alanine aminotransferase =<2.5 x upper limit of normal (ULN) Aspartate aminotransferase =<2.5 x ULN Total bilirubin =<1.5 x ULN Measured or calculated creatinine clearance >70 mL/min (see Attachment 2 for the Cockcroft-Gault formula ) To participate in the pharmacogenomic component of this study, subjects (or their legally acceptable representative) must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit) Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum beta-hCG pregnancy test at screening Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
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
Potential subjects who meet any of the following criteria will be excluded from participating in the study: Subjects with histological or clinical transformation to an aggressive lymphoma History of disallowed therapies: prior treatment with VELCADE or fludarabine. antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization nitrosoureas within 6 weeks before randomization radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization major surgery within 3 weeks before randomization chronic use of corticosteroids, such as dexamethasone Note: Prednisone =<15 mg per day or its equivalent is allowed Peripheral neuropathy or neuropathic pain of Grade 2 or worse Diagnosed or treated for a malignancy other than NHL except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, DCIS of the breast, or other solid tumors curatively treated with no evidence of disease for >5 years Active systemic infection requiring treatment. Hepatitis carriers are not excluded from this study. However, hepatitis carriers should be carefully monitored during treatment for any signs of active hepatitis infection and treatment promptly stopped if active hepatitis disease is observed. Active central nervous system lymphoma. Brain MRI is required only if clinically indicated Recently received (within the past 6 months) a live virus vaccine History of allergic reaction attributable to compounds containing boron, mannitol, rituximab, or similar agents Serious medical conditions (such as severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease, systemic infections, etc) or psychiatric illness likely to interfere with participation in this clinical study Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is not excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to determine the complete response rate (CR+CRu) following treatment with VELCADE in combination with fludarabine (VF) compared with rituximab in combination with fludarabine (RF) in subjects with recurrent advanced follicular lymphoma.;Secondary Objective: The secondary objectives are as follows: To determine the overall response rate (CR+CRu+PR) To determine the duration of response To determine time to progression (TTP) To determine progression-free survival (PFS) To determine overall survival (OS) To determine the time to subsequent anti-lymphoma thera;Primary end point(s): The primary efficacy endpoint is the complete response rate, which is defined as the proportion of responsee valuable subjects (see Section 11.1 for definition of study populations) who achieve a confirmed CR or CRu. Disease response and progression will be evaluated according to modified IWRC criteria by radiographic imaging and other procedures as necessary.
- Secondary Outcome Measures
Name Time Method