OncoMatch/Clinical Trials/NCT05807932
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
Is NCT05807932 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for myelodysplastic syndromes.
Treatment: Venetoclax · Amsacrine · Ara-C · Tacrolimus · Mycophenolate Mofetil — 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Biomarker criteria
Required: TP53 unfavorable somatic mutation
presence of unfavorable somatic mutations (e.g. TP53, RUNX1, IDH1, IDH2, KMT2A, DEK-NUP214 or RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT)
Required: RUNX1 unfavorable somatic mutation
presence of unfavorable somatic mutations (e.g. TP53, RUNX1, IDH1, IDH2, KMT2A, DEK-NUP214 or RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT)
Required: IDH1 unfavorable somatic mutation
presence of unfavorable somatic mutations (e.g. TP53, RUNX1, IDH1, IDH2, KMT2A, DEK-NUP214 or RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT)
Required: IDH2 unfavorable somatic mutation
presence of unfavorable somatic mutations (e.g. TP53, RUNX1, IDH1, IDH2, KMT2A, DEK-NUP214 or RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT)
Required: KMT2A (MLL) unfavorable somatic mutation
presence of unfavorable somatic mutations (e.g. TP53, RUNX1, IDH1, IDH2, KMT2A, DEK-NUP214 or RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT)
Required: DEK fusion with NUP214
presence of unfavorable somatic mutations (e.g. TP53, RUNX1, IDH1, IDH2, KMT2A, DEK-NUP214 or RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT)
Required: NRAS unfavorable somatic mutation
RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT
Required: KRAS unfavorable somatic mutation
RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT
Required: PTPN11 unfavorable somatic mutation
RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT
Required: CBL unfavorable somatic mutation
RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT
Required: NF1 unfavorable somatic mutation
RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT
Required: RIT1 unfavorable somatic mutation
RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT
Required: KIT unfavorable somatic mutation
RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT
Excluded: FLT3 mutation (ITD or TKD)
sAML with known FLT3 mutation (ITD or TKD)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cytotoxic therapy
Exception: oral Hydroxyurea or a maximum of 2 courses of treatment with Azacytidine or Decitabine alone or in combination with Venetoclax
previous cytotoxic therapy exceeding oral Hydroxyurea or >2 courses of treatment with Azacytidine, Decitabine or low dose Ara-C alone or in combination with Venetoclax
Cannot have received: allogeneic blood stem cell transplantation
previous allogeneic blood stem cell transplantation
Lab requirements
Kidney function
Impaired renal function (GFR < 45 ml/min) [excluded]
Liver function
Aspartate aminotransferase (AST) ≥3 x ULN or Alanine aminotransferase (ALT) ≥3 x ULN or Total bilirubin ≥1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin) or Alkaline Phosphatase ≥3 x ULN [excluded]
Cardiac function
Cardiac history of CHF (>NYHA 2) requiring treatment or Ejection Fraction < 40% or chronic stable angina [excluded]
Impaired renal function (GFR < 45 ml/min); Impaired hepatic function, as follows Aspartate aminotransferase (AST) ≥3 x ULN or Alanine aminotransferase (ALT) ≥3 x ULN or Total bilirubin ≥1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin) or Alkaline Phosphatase ≥3 x ULN; Cardiac history of CHF (>NYHA 2) requiring treatment or Ejection Fraction < 40% or chronic stable angina
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05807932 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cytotoxic therapy, allogeneic blood stem cell transplantation disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 unfavorable somatic mutation is a required biomarker for enrollment.
Does this trial require RUNX1?
Yes, RUNX1 unfavorable somatic mutation is a required biomarker for enrollment.
Does this trial require IDH1?
Yes, IDH1 unfavorable somatic mutation is a required biomarker for enrollment.
Are patients with FLT3 alterations eligible?
No. FLT3 mutation (ITD or TKD) is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify