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

• Conditions: Subjects with recurrent advanced follicular lymphoma; MedDRA version: 13.1Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2007-004151-11-GR
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-07
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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 NHL grades 1or 2 according
to the World Health Organization classification
• Subjects must have received at least 12 doses (375 mg/m squared 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
• Absolute neutrophil count (ANC) =1.2 x 10 to the ninth cells/L
• Platelets =100 x 10 to the ninth cells/L (subjects should not have received platelet
transfusion in the preceding 7 days)
• Alanine aminotransferase (ALT) =2.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) =2.5 x ULN
• Total bilirubin =1.5 x ULN
• Measured or calculated creatinine clearance >70 mL/min
• To participate in the pharmacogenomic component of this study, subjects
(or their legally acceptable representative) must sign 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 ß-hCG pregnancy test at
screening
• Subjects (or their legally acceptable representatives) must sign 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

Exclusion Criteria

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, ductal carcinoma in situ 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 (and for several months after discontinuation
of therapy) for any signs of active hepatitis infection and treatment
promptly stopped if active hepatitis disease is observed.
• Active central nervous system lymphoma. Brain magnetic resonance
imaging (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