A Phase II trial to evaluate the efficacy of Bortezomib, Cytarabine, and Dexamethasone in patients with relapsed or refractory mantle cell lymphoma
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0004010
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
A. Over 19 years old
B. Based on tissue findings obtained through biopsy, an mantle cell lymphoma was diagnosed by a pathologist.
C. Relapsed after obtaining complete response after receiving chemotherapy for mantle cell lymphoma, or experienced disease progression during follow-up monitoring without showing complete response in previous chemotherapy.
D. ECOG performance status 2 or less
E. Adequate organ system function, defined as follows within two weeks of study registration;
i. White blood cells = 3,000 /ul
ii. Absolute neutrophil count = 1,000 /ul
iii. Platelets = 50,000 /ul
iv. Hemoglobin = 9.0 g/dL
v. Total bilirubin < 2 times upper limit of normal
vi. AST, ALT < 2.5 times upper limit of normal
vii. Serum creatinine < 1.5 times upper limit of normal
F. Understand and comply with contents of the research document and provide written informed consent voluntarily.
G. Willingness and ability to comply with visit schedules, treatment plans, laboratory tests and other study procedures.
A. Previously treated with 4 or more lines of chemotherapy for mantle cell lymphoma
B. Previously treated with bortezomib-containing regimen for mantle cell lymphoma
C. Treated with a cytarabine-containing regimen as the last line and within 6 months
before registration
D. Prohibited from investigator products
E. Other cancer diagnosed within 5 years before registration except mantle cell lymphoma
F. Uncontrolled symptomatic Central Nervous System(CNS) involvement of mantle cell lymphoma
G. Uncontrolled systemic infection
H. Inherited immunodeficiency disease or acquired immune deficiency syndrome
I. Pregnancy
J. Breast-feeding woman
K. Peripheral neuropathy of grade 3 or higher
L. Other health conditions considered to be inappropriate for this trial in the primary
physician's opinion
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response
- Secondary Outcome Measures
Name Time Method Complete response;Overall survival;Progression-free survival;Quality of life;Toxicity