Phase I/II study of bendamustine, fludarabine and cyclophosphamide conditioning for allogeneic stem cell transplantation in refractory follicular lymphoma (KSGCT1301 / FL benda)
Phase 1
- Conditions
- follicular lymphoma(FL)
- Registration Number
- JPRN-UMIN000012122
- Lead Sponsor
- Kanto Study Group for Cell Therapy (KSGCT)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients should not have controllable disease by chemotherapy (2) Uncontrolled diabetes mellitus (3) Uncontrolled hypertension (4) Active infection (5) Positive for TPHA, HBs Ag, HBe Ag, or HCV Ab (6) Positive for HIV Ab (7) Patients should be expected that they survive over 100 days after transplantation. (8) Patients should not have other active malignant diseases. (9) Pregnant or nursing women (10) Mental disorder (11) Previous allogeneic transplantation (12) Other inappropriate symptoms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I study: Incidence of dose-limiting toxicity Phase II study: Overall survival at 1 year
- Secondary Outcome Measures
Name Time Method (1) Engraftment at 30 days (2) Incidence of grade 3-4 toxicity at 30 days (3) Response rate (4) Progression free survival at 1 year (5) Non-relapse mortality at 1 year (6) Incidence of infection (7) Incidence of acute GVHD, chronic GHVD (8) Influence of cardiac function