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
Sponsor: Heinrich-Heine University, Duesseldorf • ClinicalTrials.gov ID: NCT05807932
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This trial aims to find the MTD of Venetoclax when added to Fludarabin, Amsacrine and Ara-C + Treosulfan and to evaluate whether the addition of Venetoclax to sequential conditioning with FLAMSA + Treosulfan is safe for allogeneic blood stem cell transplantation in patients with high-risk MDS, CMML or sAML (FLAMSAClax)
Interventions
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Venetoclax
(Drug)
Study treatment consists of the conditioning therapy including 6 or 8 days of Venetoclax treatment.
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Amsacrine
(Drug)
Amsacrine is part of the conditioning therapy and is administered on day -10 to -7 before allogeneic blood stem cell transplantation
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Ara-C
(Drug)
Ara-C is part of the conditioning therapy and is administered on day -10 to -7 before allogeneic blood stem cell transplantation
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Tacrolimus
(Drug)
Tacrolimus is used for prophylaxis of acute and chronic graft-versus-host-disease according to institutional standards.
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Mycophenolate Mofetil
(Drug)
Mycophenolate Mofetil is used for prophylaxis of acute and chronic graft-versus-host-disease according to institutional standards.
Eligibility criteria
Conditions
Locations
- Universitätsklinikum Aachen - Med. Klinik IV — Aachen, North Rhine-Westphalia, Germany
- Universitätsklinikum Düsseldorf - Klinik für Hämatologie, Onkologie und Klinische Immunologie — Düsseldorf, North Rhine-Westphalia, Germany
- Universitätsklinikum Köln Klinik I für Innere Medizin — Cologne, Germany
- Universitätsklinikum Frankfurt Medizinische Klinik II — Frankfurt, Germany
- Universitätsklinikum Jena - Klinik für Innere Medizin II — Jena, Germany
- Klinikum rechts der Isar der TU München Klinik und Poliklinik für Innere Medizin III — München, Germany
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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