A Phase 2 Study of VELCADE™ in Subjects with Relapsed or Refractory follicular B-cell Lymphoma
- Conditions
- Follicular Lymphoma
- Registration Number
- EUCTR2005-000734-21-BE
- Lead Sponsor
- Groupe d'Etude des Lymphomes de l'Adulte (GELA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
•Male or female subject 18 years or older.
•Initial diagnosis of follicular B-cell lymphoma (CD20+) (grades 1, 2, and 3 based on the World Health Organization 1997 classification), in first or subsequent relapse or progression after prior anti-neoplastic treatment including previous rituximab treatment. Relapse or progression since previous anti-neoplastic therapy must be documented by new lesions or objective evidence of progression of existing lesions.
•At least 1 measurable lymph node mass that is >1.5 cm in 2 perpendicular dimensions, and has not been previously irradiated or has grown since previous irradiation.
•No active CNS lymphoma
•KPS >= 50% (Eastern Cooperative Oncology Group [ECOG] 0-2)
•The following laboratory values at screening, unless abnormalities are related to the lymphoma: Absolute neutrophil count (ANC) >= 1000 cells/microL; Platelets >= 50,000 cells/microL;Aspartate transaminase (AST) <= 3 x ULN; Alanine transaminase (ALT) <= 3 x ULN; Total bilirubin <= 2 x ULN; Creatinin level <= 150 micromol/L
•Toxic effects of previous therapy or surgery resolved to Grade 2 or better.
•Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Women are neither breast feeding nor pregnant for the duration of the study. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Male subject agrees to use an acceptable method for contraception for the duration of the study.
•Voluntary signed informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
•Patient with minimum life expectancy of 3 months.
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
•Any other type of lymphoma
•Previous treatment with Velcade™.
•Anti-neoplastic or experimental or radiation therapy within 3 weeks before Day 1 of Cycle 1.
•Major surgery within 2 weeks before Day 1 of Cycle 1.
•Rituximab, alemtuzumab (Mabcampath®), or other unconjugated therapeutic antibody within 10 weeks before Day 1 of Cycle 1
•Nitrosoureas within 6 weeks before Day 1 of Cycle 1.
•Radioimmunoconjugates or toxin immunoconjugates such as ibritumomab tiuxetan (Zevalin™), or tositumomab (Bexxar®) within 10 weeks before Day 1 of Cycle 1.
•Peripheral neuropathy or neuropathic pain of Grade 3 or worse.
•History of allergic reaction attributable to compounds containing boron or mannitol.
•Diagnosed or treated for a malignancy other than NHL within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy. Subjects previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score >=7, and a prostate specific antigen (PSA) >=10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (ie, prostatectomy or radiotherapy) <=2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
•Active systemic infection requiring treatment.
•Previously known HIV positive serology
•Serious medical 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 allowed, if it will not interfere with participation in this study.
•Adult patient under guardian.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the response rate (complete response [CR] + complete response unconfirmed [CRu] + partial response [PR]) to Velcade™ as single agent, according to criteria based on those developed by Cheson at al. ;Secondary Objective: •To determine the overall CR rate (CR + CRu)<br>1.To determine time to progression (TTP) <br>2.To determine overall survival<br>3.To determine duration of response <br>4.To determine the time to best response<br>5.To evaluate the safety and tolerability of Velcade™ <br>6.To evaluate the effects of Velcade™ given bis weekly at 1.5 mg /m2 versus 1.6 mg/m2 weekly<br>;Primary end point(s): disease response rate (CR + CRu + PR)
- Secondary Outcome Measures
Name Time Method