Venetoclax+Azacytidine+Modified BUCY Conditioning Regimen for Acute Myeloid Leukemia and Myelodysplastic Syndromes Undergoing Allo-HSCT

NCT05823714 | Unknown Phase 2

• 1 other identifier: VA+mBUCY-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective, open-label, single-center study is to evaluate the efficacy and safety of VEN-AZA (venetoclax and azacytidine) followed by modified BUCY (busulfan and cyclophosphamide) as conditioning regimen for high-risk myelodysplastic syndrome (MDS) and high-risk or relapsed/refractory acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation; Acute Myeloid Leukemia; Myelodysplastic Syndrome

Keywords

venetoclax; azacytidine; hematopoietic stem cell transplantation; acute myeloid leukemia; myelodysplastic syndrome

Outcome Measures

Primary Outcomes (2)

• disease-free survival (DFS)

  It is measured from the time from randomization to the first of relapse or death.

  3 years after transplantation

• overall survival (OS)

  It is measured from the time of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.

  3 years after transplantation

Secondary Outcomes (4)

• veno-occlusive disease (VOD)

  3 years after transplantation

• graft-versus-host disease (GvHD)

  3 years after transplantation

• transplant related mortality (TRM)

  3 years after transplantation

• Regimen related toxicity

  3 years after transplantation

Study Arms (1)

VEN+AZA+Modified BUCY

EXPERIMENTAL

Drug: VEN+AZA+Modified BUCY

Interventions

VEN+AZA+Modified BUCY DRUG

Venetoclax: 200mg/day\*7days（It should be combined with triazole antifungal drugs). Azacytidine: 75mg/ m²/day\*7days.

VEN+AZA+Modified BUCY

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 8 to 65 years;
• Diseases must be MDS and AML; high-risk MDS: int-2 risk, high risk by the IPSS; IPSS-R int-risk (\> 3.5 points), high risk, very high risk; high risk,very high risk by the WPSS; high-risk or relapsed/refractory AML: (1) age≥60 years; (2) High white blood cell count at first diagnosis (WBC≥100\*10\^9/L); (3) secondary AML (previous history of MDS, myeloproliferative disease, or treatment-related AML, etc.); (4) Complicated with extramedullary leukemia, such as central nervous system leukemia, granulocytic sarcoma, hepatosenomegaly; （5）high risk factors and relapsed/refractory AML（reference 2022-AML-ELN guideline）（6）not in remission or ≥CR2 before transplantation;
• Must need a bone marrow transplant;
• Must have the ability to observe the efficacy and events;
• Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed.

You may not qualify if:

• Age \<8 or \>65 years;
• Uncontrolled bacterial, viral, fungal, or other infection before conditioning regimen;
• Pregnant or lactating females;
• Current participation in another clinical trial;
• Contra-indication to one of the drug of the regimen;
• Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Study Officials

• Depei Wu Wu, MD

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Xiaowen Tang, MD

CONTACT

+86-512-67781851; xwtang1020@163.com

Depei Wu, MD

CONTACT

+86-512-67781851; wudepei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 21, 2023
• Study Start: January 20, 2022
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2026
• Last Updated: April 21, 2023

Record last verified: 2023-02

Locations

CN (1)