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 (May 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
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.
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