NCT04942730 (FluBuBe) is a Phase 2 clinical trial of Fludarabine in Leukemia, Acute Lymphoblastic, sponsored by St. Petersburg State Pavlov Medical University.

Who is sponsoring NCT04942730?

NCT04942730 is sponsored by St. Petersburg State Pavlov Medical University.

What drugs are being tested in NCT04942730?

Interventions in NCT04942730: Fludarabine, Bendamustine Hydrochloride, Busulfan, Cyclophosphamide, Mycophenolate Mofetil, Tacrolimus 5Mg Cap.

What condition does NCT04942730 study?

NCT04942730 studies Leukemia, Acute Lymphoblastic, Myeloid Leukemia, Acute, Biphenotypic Acute Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndromes, Myeloproliferative Neoplasm.

Is NCT04942730 still recruiting?

NCT04942730 is currently completed. Last updated 7 May 2024.

Last reviewed 2024-05-07 · How we verify

NCT04942730: FluBuBe

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 7 May 2024

What this trial tests

Phase 2 trial testing Fludarabine in Leukemia, Acute Lymphoblastic in 50 participants. Completed in 30 April 2024.

Timeline

21 January 2021

Primary endpoint
30 April 2024

30 April 2024

Quick facts

Lead sponsor	St. Petersburg State Pavlov Medical University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	21 January 2021
Primary completion	30 April 2024
Estimated completion	30 April 2024
Sites	1 location across Russia

Drugs / interventions tested

Fludarabine (FLUDARABINE) — full drug profile →
Bendamustine Hydrochloride — full drug profile →
Busulfan — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
Mycophenolate Mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
Tacrolimus 5Mg Cap

Conditions studied

Leukemia, Acute Lymphoblastic — all drugs for Leukemia, Acute Lymphoblastic →
Myeloid Leukemia, Acute — all drugs for Myeloid Leukemia, Acute →
Biphenotypic Acute Leukemia — all drugs for Biphenotypic Acute Leukemia →
Lymphoblastic Lymphoma — all drugs for Lymphoblastic Lymphoma →

Sponsor

St. Petersburg State Pavlov Medical University

Who can join

Adults 18 to 75, any sex, with Leukemia, Acute Lymphoblastic or Myeloid Leukemia, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Low incidence of primary graft failure with bendamustine, fludarabine, and busulfan conditioning prior to haploidentical allogeneic hematopoietic cell transplantation.
Moiseev IS, Cherkashina AN, Rudakova TA, Volkov NP, et al · · 2024 · PMID 39829096 · DOI 10.4103/hemoncstem.hemoncstem-d-24-00026

Verify or expand the search:

Other trials of Fludarabine

Trials testing the same drug.

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Other recruiting trials for Leukemia, Acute Lymphoblastic

Currently open trials in the same condition.

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NCT05306301 — Ponatinib Plus Chemotherapy in Acute Lymphoblastic Leukemia Patients · Phase 2 · active not recruiting
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Other St. Petersburg State Pavlov Medical University trials

Trials by the same sponsor.

NCT07238712 — Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies · Phase 2 · recruiting
NCT06871007 — Nivolumab and DA-EPOCH-R in Pediatric Primary Mediastinal (Thymic) Large B-cell Lymphoma · Phase 1, PHASE2 · enrolling by invitation
NCT05757466 — Prolgolimab Monotherapy or in Combination With Bendamustine for r/r Classical Hodgkin Lymphoma · Phase 2 · unknown
NCT06022952 — The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents · NA · unknown
NCT05591716 — Evaluation of the Efficacy and Safety of Unimodal Bilateral Flexible Ureteroscopy. · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04942730 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by St. Petersburg State Pavlov Medical University
Last refreshed: 7 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04942730.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing