NCT05807932View on ClinicalTrials.gov

Venetoclax in Addition to Sequential Conditioning With Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for Allogeneic Blood Stem Cell Transplantation in Patients With MDS, CMML or sAML

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

June 26, 2023

Primary Completion Date

January 31, 2026

Study Completion Date

January 30, 2028

Conditions
Myelodysplastic SyndromesSecondary Acute Myeloid LeukemiaChronic Myelomonocytic Leukemia
Interventions
DRUG

Venetoclax

Study treatment consists of the conditioning therapy including 6 or 8 days of Venetoclax treatment.

DRUG

Amsacrine

Amsacrine is part of the conditioning therapy and is administered on day -10 to -7 before allogeneic blood stem cell transplantation

DRUG

Ara-C

Ara-C is part of the conditioning therapy and is administered on day -10 to -7 before allogeneic blood stem cell transplantation

DRUG

Tacrolimus

Tacrolimus is used for prophylaxis of acute and chronic graft-versus-host-disease according to institutional standards.

DRUG

Mycophenolate Mofetil

Mycophenolate Mofetil is used for prophylaxis of acute and chronic graft-versus-host-disease according to institutional standards.

Trial Locations (6)

40225

RECRUITING

Universitätsklinikum Düsseldorf - Klinik für Hämatologie, Onkologie und Klinische Immunologie, Düsseldorf

50937

RECRUITING

Universitätsklinikum Köln Klinik I für Innere Medizin, Cologne

52074

RECRUITING

Universitätsklinikum Aachen - Med. Klinik IV, Aachen

60590

RECRUITING

Universitätsklinikum Frankfurt Medizinische Klinik II, Frankfurt

81675

RECRUITING

Klinikum rechts der Isar der TU München Klinik und Poliklinik für Innere Medizin III, München

07747

RECRUITING

Universitätsklinikum Jena - Klinik für Innere Medizin II, Jena

All Listed Sponsors
collaborator

Koordinierungszentrum für Klinische Studien - Duesseldorf

UNKNOWN

lead

Heinrich-Heine University, Duesseldorf

OTHER