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

NCT04942730 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-05-07

No results posted yet for this study

Summary

Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning and graft-versus-host disease prophylaxis is associated with high frequency of primary and secondary graft failure. Different technologies of with replete or depleted graft are associated with 10-20% of graft failures. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of disease. Furthermore combination of fludarabine and bendamustine was sufficient to facilitate engraftment in patients with chronic lymphocytic leukemia and lymphomas. The aim of the study is to evaluate whether addition of bendamustine to fladarabine and busulfan conditioning reduces the risk of primary graft failure after haploidentical allograft.

Conditions

  • Leukemia, Acute Lymphoblastic
  • Myeloid Leukemia, Acute
  • Biphenotypic Acute Leukemia
  • Lymphoblastic Lymphoma
  • Myelodysplastic Syndromes
  • Myeloproliferative 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.

Sponsors & Collaborators

  • St. Petersburg State Pavlov Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04942730 on ClinicalTrials.gov