OncoMatch/Clinical Trials/NCT06686108

Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention

Is NCT06686108 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Azacitidine (AZA) Days 1 - 5 and Decitabine (DAC) for t-cell acute lymphoblastic leukemia.

Phase 2RecruitingShanghai General Hospital, Shanghai Jiao Tong University School of MedicineNCT06686108Data as of May 2026

Treatment: Azacitidine (AZA) Days 1 - 5 · Decitabine (DAC) · Venetoclax — This study is a prospective, phase II clinical trial with the primary objective of assessing the effectiveness of demethylating agents combined with venetoclax in the prevention of recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT) of high risk T-lymphoblastic lymphoma/leukemia (T-LBL/ALL) patients.

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Biomarker criteria

Allowed: FLT3 mutation

gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations

Allowed: NRAS mutation

gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations

Allowed: KRAS mutation

gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations

Allowed: PTEN mutation

gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations

Allowed: IL7R mutation

gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations

Allowed: JAK1 mutation

gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations

Allowed: JAK3 mutation

gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations

Allowed: DNMT3A mutation

gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations

Allowed: IDH1 mutation

gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations

Allowed: IDH2 mutation

gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations

Allowed: TP53 mutation

gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations

Allowed: BCL2 mutation

gene mutations involving myeloid related genes, RAS/PI3K/AKT, JAK/STAT signaling pathway, and epigenetics, such as FLT3, NRAS/KRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations

Allowed: MYC rearrangement

t (8; 14) (q24; q11)/MYC rearrangement

Allowed: TCR-LYL1 fusion

t (7; 19) (q34; p13)/TCR-LYL1

Allowed: TCR-MEF2C fusion

TCR-MEF2C

Allowed: NOTCH1 mutation

NOTCH1

Allowed: FBXW7 mutation

FBXW7

Allowed: PHF6 mutation

PHF6

Allowed: EP300 mutation

EP300

Allowed: IKZF1 mutation

IKZF1

Allowed: DNMT3A mutation

DNTM3A

Allowed: IDH1 mutation

IDH1

Allowed: IDH2 mutation

IDH2

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: allogeneic hematopoietic stem cell transplant

Patients with allo-HSCT due to T-LBL/ALL

Cannot have received: BCL-2 inhibitor

Exception: resistant to BCL-2 inhibitors before transplantation, if the disease progresses during the application process, or if 3-4 courses of induction therapy containing BCL2 inhibitors do not improve

For those who are resistant to BCL-2 inhibitors before transplantation, if the disease progresses during the application process, or if 3-4 courses of induction therapy containing BCL2 inhibitors do not improve

Lab requirements

Blood counts

ANC ≥ 1.0 × 10^9/L, PLT ≥ 50 × 10^9/L

Kidney function

endogenous creatinine clearance rate (Ccr) less than 50mL/min or 1.5 times the normal value of blood creatinine [excluded]

Liver function

AST/ALT more than 3 times the normal value or direct bilirubin more than 3 times normal value [excluded]

Blood routine: ANC ≥ 1.0 × 10^9/L, PLT ≥ 50 × 10^9/L. AST/ALT more than 3 times the normal value or direct bilirubin more than 3 times normal value [excluded]. Endogenous creatinine clearance rate (Ccr) less than 50mL/min or 1.5 times the normal value of blood creatinine [excluded].

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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