Table 1.
Clinical trials using pre-transplant bendamustine in allogeneic HCT.
| N | Age | Donor Graft |
Disease | Remission Status % |
Regimen | Engraft % |
aGvHD II-IV % |
cGvHD % |
NRM % |
OS % |
PFS % |
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Khouri (Houston, Texas) 2009- NCT00880815 Phase I/II Dose escalation of BEN (70, 90, 110, and 130 mg/m2) |
69 closed |
30-72 | MSD or MUD PBSC or BM |
CLL Lymph |
42 CR 46 PR 12 RD |
RIC FLU-BEN- -Ritux |
100 | 17 | 31 | 9 | 74 @ 5y |
60 @ 5yr |
|
Khouri (Houston, Texas) 2009- NCT00880815; NCT00899431 Evaluation of BFR conditioning compared to FCR |
26 closed |
49-72 | MSD or MUD PBSC or BM |
CLL | 8 CR 54 PR 38 RD |
RIC FLU-BEN- -Ritux or FLU-CY-Ritux |
100 | 23 | 45 | 8 | 82 @ 3y |
63 @ 3y |
BEN = bendamustine, MSD = matched sibling donor, MUD = matched unrelated donor, PBSC = peripheral blood stem cells, BM = bone marrow, CLL = chronic lymphocytic leukemia, CR = complete remission, PR = partial remission, RD = refractory disease; RIC = reduced intensity conditioning, FLU = fludarabine, Ritux = rituximab, Engraft = engraftment; aGvHD = acute graft versus host disease, cGvHD = chronic graft versus host disease, NRM = non-relapse mortality, OS = overall survival, PFS = progression free survival; BFR = bendamustine fludarabine rituximab; FCR = fludarabine cyclophosphamide rituximab; CY = cyclophosphamide.