RecruitingPhase 1Phase 2NCT05807932

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

Phase-I/II Trial to Assess the Safety and Efficacy of 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 (FLAMSAClax


Sponsor

Heinrich-Heine University, Duesseldorf

Enrollment

38 participants

Start Date

Jun 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding venetoclax (a targeted cancer drug) to an intensive conditioning regimen before a stem cell transplant improves outcomes for patients with certain blood cancers: MDS (a bone marrow disorder), CMML (a rare blood cancer), or secondary AML (leukemia that developed from another blood condition). **You may be eligible if...** - You have been diagnosed with MDS, CMML, or secondary AML according to WHO criteria with high-risk features (blast count above 5% or certain dangerous gene mutations) - A stem cell transplant from a donor has been planned as part of your treatment - You are in acceptable overall health for transplant - You have signed informed consent **You may NOT be eligible if...** - You have a different type of leukemia or blood cancer not listed - You are too unwell to undergo stem cell transplantation - You have received certain prior treatments that conflict with the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

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

DRUGAmsacrine

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

DRUGAra-C

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

DRUGTacrolimus

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

DRUGMycophenolate Mofetil

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


Locations(6)

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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NCT05807932


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