follicular lymphoma(FL)
Conditions
Interventions
A standard 3+3 trail is designed. Three patients are enrolled on the first bendamustine dose level. Dose limiting toxicity (DLT) is defined as any grade 3 or 4 non-hematologic toxicity (except alopec
Sponsors
Kanto Study Group for Cell Therapy (KSGCT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patient must be diagnosed follicular lymphoma, and age must be equal and over 16 years or less than 66 years. (2)Patient must have relapsed, primary refractorylymphoma. (3)Patient may have chemoresistant refractory disease. (4)Patient should not receive chemotherapy except rituximab within 4 weeks before transplantation. (5)Patiens should not have pathologically transformed disease. (6)Patients must have HLA identical sibling donor, HLA one antigen mismatched sibling donor, HLA identical unrelated donor or HLA DRB1 allele one mismatched unrelated donor. (7)Patients must have an Eastern Cooperative Oncology Group performance status of 0 or 1. (8) 1)Saturation of oxygen >= 94% 2)DLCO >= 50% 3)Serum creatinine <= 1.5mg/dl 4)Total bilirubin <= 1.5mg/dl 5)AST, ALT, r-GTP <= 3 times upper limit of normal 6)No evidence of active cardiac disease 7)Left ventricular ejection fraction >= 55% (9)All patients must be informed of the investigational nature of the study and have given written consent.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I study: Incidence of dose-limiting toxicity Phase II study: Overall survival at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactShingo Yano
Kanto Study Group for Cell Therapy Trial Office
Outcome results
None listed