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Studies

Interventional Recruiting Phase 1/Phase 2

NCT05807932 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

Official title: 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 Düsseldorf
  • Collaborators: Koordinierungszentrum für Klinische Studien - Duesseldorf
  • Enrollment: 38 (Estimated)
  • Study start: 2023-06-26 (Actual)
  • Primary completion: 2029-04-30 (Estimated)
  • Study completion: 2029-04-30 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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)

Conditions

  • Myelodysplastic Syndromes
  • Secondary Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia

Intervention / Treatment

  • Drug: Venetoclax
  • Drug: Amsacrine
  • Drug: Ara-C
  • Drug: Tacrolimus
  • Drug: Mycophenolate Mofetil

Primary Outcome Measures

  • The primary target variable is safety, defined as the maximal organ toxicity to each organ system according to CTC criteria as well as the number of AEs of grade III or greater within the first 30 days (± 3) after transplantation (inclusion until day 30 (± 3) after transplantation)
    maximal organ toxicity to each organ system according to CTC criteria as well as the number of AEs of grade III or greater within the first 30 days (± 3) after transplantation

Countries

Germany

Locations and Investigators

  • University Hospital Cologne AöR, Cologne, Germany
    • Udo, Holtick
  • Universitaetsklinikum Aachen AöR, Aachen, Germany
    • Edgar, Jost
  • Universitaetsklinikum Jena KöR, Jena, Germany
    • Inken, Hilgendorf
  • Universitaetsklinikum Frankfurt AöR, Frankfurt Am Main, Germany
    • Gesine, Bug
  • Klinikum rechts der Isar der TU Muenchen AöR, Munich, Germany
    • Peter, Herhaus
  • Universitaetsklinikum Duesseldorf AöR, Duesseldorf, Germany

Study Officials

  • Guido Kobbe, Prof. Dr. (Principal Investigator) — Coordinating Investigator