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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 (Jun 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 Jun 2026Location: China

Treatment: Azacitidine (AZA) Days 1 - 5 · Decitabine (DAC) · VenetoclaxThis 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

Treatments studied

Targeted therapy

Venetoclax

Other

Azacitidine (AZA) Days 1 - 5Decitabine (DAC)

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)

Demographics

Ages 14–55

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.

Frequently asked questions

Is NCT06686108 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior BCL-2 inhibitor disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 55 years or younger and at least 14 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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