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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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514688-24-00
Acronym
FLAMSAClax
Enrollment
38
Registered
2024-07-25
Start date
2023-05-26
Completion date
Unknown
Last updated
2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or secondary acute myeloid leukemia (sAML) before stem cell transplantation

Brief summary

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 until day +30 (± 3) after transplantation

Detailed description

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 until day +100 (± 7) after transplantation, graft failure defined as no donor chimerism at day +30 (± 3) after transplantation, incidence, course und severity of aGvHD and cGvHD during the first 2 years after transplantation, incidence, course and severity of VOD, time (days from day 0) to hematopoietic reconstitution (ANC>500/µl, PLT>20000/µl and PLT>50000/µl), time (days from day 0) to transfusion independence, best disease response within the first 100 days (± 7) after transplantation (according to IWG-criteria for MDS and ELN-criteria for AML), disease response and donor chimerism at day +30 (± 3), +60 (± 7) and +100 (± 7) after transplantation (according to IWG-criteria for MDS and ELN-criteria for AML), time (days from day 0) to complete donor chimerism in blood and marrow, disappearance of molecular markers of disease (yes/no, time in days from day 0 ), event-free survival (EFS, death, relapse and disease progression will be recorded as event), cumulative incidence of relapse (CIR, disease progression and relapse will be recorded as event), overall survival (OS, death will be recorded as event)

Interventions

DRUGPEGFILGRASTIM
DRUGFLUDARABINE
DRUGFEBUXOSTAT
DRUGTACROLIMUS
DRUGMYCOPHENOLIC ACID
DRUGFILGRASTIM
DRUGALLOPURINOL
DRUGTREOSULFAN
DRUGVenetoclax
DRUGCYTARABINE

Sponsors

Heinrich-Heine-Universitaet Duesseldorf
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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 until day +30 (± 3) after transplantation

Secondary

MeasureTime frame
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 until day +100 (± 7) after transplantation, graft failure defined as no donor chimerism at day +30 (± 3) after transplantation, incidence, course und severity of aGvHD and cGvHD during the first 2 years after transplantation, incidence, course and severity of VOD, time (days from day 0) to hematopoietic reconstitution (ANC>500/µl, PLT>20000/µl and PLT>50000/µl), time (days from day 0) to transfusion independence, best disease response within the first 100 days (± 7) after transplantation (according to IWG-criteria for MDS and ELN-criteria for AML), disease response and donor chimerism at day +30 (± 3), +60 (± 7) and +100 (± 7) after transplantation (according to IWG-criteria for MDS and ELN-criteria for AML), time (days from day 0) to complete donor chimerism in blood and marrow, disappearance of molecular markers of disease (yes/no, time in

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026