Clinical Study of Venetoclax Combined With Azacitidine as Bridging Therapy Prior to Hematopoietic Stem Cell Transplantation in Patients With Higher-Risk Myelodysplastic Syndromes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2029-06-30

Brief Summary

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A Single-Arm, Prospective Clinical Study of Venetoclax Combined with Azacitidine Followed by Bridging Transplantation in Patients with High-Risk Myelodysplastic Neoplasms with Increased Blasts 2 (MDS-IB2)

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Detailed Description

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This is a single-center, single-arm, prospective study investigating pre-transplant bridging therapy in patients aged ≥18 years with higher-risk MDS-IB2. The study plans to enroll 46 eligible patients. Participants will receive Venetoclax combined with Azacitidine, administered in 28-day cycles for 1 to 2 cycles. Treatment response will be assessed according to the IWG 2023 HR-MDS response criteria.Patients achieving modified Composite Complete Remission (mCRc: CR or CR-equivalent + CRL + CRh) after Cycle 1 will proceed directly to transplantation. Patients not achieving mCRc will receive a second cycle of therapy. All patients will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 3 months after completing Cycle 2, regardless of mCRc status. Patients unable to proceed to transplantation will receive standard institutional care and undergo follow-up.

Conditions

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Myelodysplastic Neoplasms Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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venetoclax + Azacitidine

Group Type EXPERIMENTAL

VEN (Venetoclax)

Intervention Type DRUG

Enrolled patients will receive: Venetoclax: 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3-14. Azacitidine: 75 mg/m² on Days 1-7. Cycle duration: 28 days Total cycles: 1 to 2 cycles

Interventions

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VEN (Venetoclax)

Enrolled patients will receive: Venetoclax: 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3-14. Azacitidine: 75 mg/m² on Days 1-7. Cycle duration: 28 days Total cycles: 1 to 2 cycles

Intervention Type DRUG

Other Intervention Names

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Azacitidine

Eligibility Criteria

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Inclusion Criteria

1. Newly diagnosed MDS confirmed by morphological and immunophenotypic analysis of bone marrow；
2. Age ≥18 years, any gender；
3. Bone marrow blasts ≥10%；
4. IPSS-R score \>4.5；
5. ECOG performance status 0-2；
6. Scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT)；
7. Adequate major organ function：

* Cardiac: LVEF ≥50%
* Hepatic: Bilirubin ≤1.5×ULN
* AST/ALT ≤2.5×ULN
* Renal: Creatinine clearance ≥60 mL/min；
8. Written informed consent provided by the patient or legally authorized representative.

Exclusion Criteria

1. Extramedullary disease involvement；
2. Hypersensitivity to any study drugs；
3. Clinically significant hepatic/renal dysfunction exceeding inclusion thresholds；
4. Severe cardiac disease, including congestive heart failure, myocardial infarction, and cardiac insufficiency;
5. Concurrent malignant tumors of other organs, which can be enrolled if previously cured;
6. Active tuberculosis or HIV infection;
7. Concomitant hematologic disorders;
8. Pregnancy or lactation;
9. Inability to comply with protocol requirements;
10. Concurrently participating in other clinical studies.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No