Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 21, 2021

Primary Completion Date

April 30, 2024

Study Completion Date

April 30, 2024

Conditions
Leukemia, Acute LymphoblasticMyeloid Leukemia, AcuteBiphenotypic Acute LeukemiaLymphoblastic LymphomaMyelodysplastic SyndromesMyeloproliferative Neoplasm
Interventions
DRUG

Fludarabine

30 mg/m2/day iv x 6 days, days -7 through -2 of HSCT

DRUG

Bendamustine Hydrochloride

130 mg/m2 iv x 2 days, Days -7 through -6 of HSCT

DRUG

Busulfan

1 mg/kg po qid x 3 days, Days -5 through -3

DRUG

Cyclophosphamide

50 mg/kg iv x 2 days, Days +3 through +4

DRUG

Mycophenolate Mofetil

45 mg/kg/day, maximum 3 g/day, iv or po x 30 days, Days +5 through +35

DRUG

Tacrolimus 5Mg Cap

0.03 mg/kg/day iv or po, Days +5 through +100 with with further correction by concentration. Target concentration 5-15 ng/ml.

Trial Locations (1)

197022

RM Gorbacheva Research Institute, Saint Petersburg

All Listed Sponsors
lead

St. Petersburg State Pavlov Medical University

OTHER

NCT04942730 - Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe) | Biotech Hunter | Biotech Hunter