Open labeled, single arm, multi centered, phase II trial to evaluate the efficacy and safety of combination therapy of rituximab and cladribine for previously untreated patients with advanced staged extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma
- Conditions
- Malignant lymphoma, non-Hodgkin lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) and nodal marginal zone B-cell lymphoma
- Registration Number
- JPRN-UMIN000004205
- Lead Sponsor
- Hematological Malignancy Clinical Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 43
Not provided
(1)Histologically transformed lymphoma. (2)History of glaucoma (3)Peripheral lymphoma cells> 5000/uL (4)Serious bacterial or viral infections. (5)Positive for HBs antigen, HCV antibody or HIV antibody (6)Active cancer or history of malignancies within 5 years, except for carcinoma in situ (7)Interstitial pneumonia, pulmonary fibrosis, or severe pulmonary emphysema. (8)Serious complications (cardiac failure, hepatic failure or renal failure) (9)Psychological complications judged to be difficult to enroll (10)Active disease or history of autoimmune anemia. (11)Serious bleeding tendencies (e.g. disseminated intravascular coagulation) (12)Patients who received granulacyte colony stimulating factor within 2 weeks before registration. (13)Active or suggestive CNS involvement (14)Patients who are pregnant or lactating (15)Inadequate patients to enroll judged by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two-year progression-free survival
- Secondary Outcome Measures
Name Time Method Complete response rate Overall response rate Two-year overall survival rate Time to response Remission duration