A Novel Conditioning Regimen for Myelodysplastic Syndrome With Moderate High IPSS-M Score

NCT06279338 | Unknown

• 1 other identifier: [2023] No.0969
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome with Moderate High IPSS-M Score

Conditions

Myelodysplastic Syndromes

Keywords

Allogeneic Hematopoietic Stem Cell Transplantation; Molecular International Prognostic Scoring System (IPSS-M); Azacitidine

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) at 18 months post-transplant, month

  PFS is measured from the date of allo-HSCT to the date of relapse or death from any cause or the last follow-up for surviving patients.

  18 months post-transplantation

Secondary Outcomes (1)

• Overall survival (OS) at 18 months post-transplant, month

  18 months post-transplantation

Study Arms (1)

Azacitidine

EXPERIMENTAL

Combining azacitidine with classic BUCY2 regimen as conditioning regimen

Drug: Azacitidine Injection

Interventions

Azacitidine Injection DRUG

On the basis of the conventional transplantation treatment regimen, combining azacitidine injection with BUCY2 conditioning regimen (azacitidine 75 mg/m2/d for -11 days to -5 days, cytarabine 2 g/m2 q12h for -8 days to -7 days, cyclophosphamide 1.8 g/m2/d for -6 days to -5 days, busulfan 3.2 mg/kg/d for -4 days to -2 days)

Also known as: Azacitidine

Azacitidine

Eligibility Criteria

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

You may qualify if:

• Patients fully understand this study, voluntarily participate and sign the informed consent form
• Age equal or more than 18 years old
• Patients with moderate high-risk MDS with an IPSS-M score which is higher than 0
• Patients planning to undergo allogeneic hematopoietic stem cell transplantation, HCT-CI ≤ 3 or KPS ≥ 80%

You may not qualify if:

• Patients who refuse to participate in this clinical study
• Patients with central nervous system involvement
• Patients with HIV seropositive
• Patients with other serious medical conditions with a life expectancy of less than six months
• Patients with severe psychiatric or psychological disorders

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Linghui Xia

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiena Cao

CONTACT

0086-13031186262; caoxiena@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-01