NCT06918834

Brief Summary

This study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (HSCT) is non-inferior to HSCT following bridging therapy in patients with higher-risk myelodysplastic syndrome (HR-MDS).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for phase_2

Timeline
23mo left

Started Jul 2025

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Jul 2025Apr 2028

First Submitted

Initial submission to the registry

March 11, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 24, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

2.7 years

First QC Date

March 11, 2025

Last Update Submit

September 5, 2025

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

  • 2-year Disease-Free Survival (DFS) post-HSCT

    Defined as the time from transplantation to two years post-HSCT, with primary events including death or failure to achieve CR or CR equivalent at the time of assessment

    2-year

Secondary Outcomes (6)

  • Cumulative Incidence of Allogeneic HSCT

    The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization.

  • Complete Remission (CR) or CR Equivalent Rate from Randomization

    2-year

  • 2-year Overall Survival (OS) post-HSCT

    2-year

  • 2-year Leukemia-Free Survival (LFS) from Randomization

    2-year

  • 2-year Quality of Life (QoL) Assessment: 2-year Quality of Life (QoL) Assessment from Randomization

    2-year

  • +1 more secondary outcomes

Study Arms (2)

Immediate HSCT Group

EXPERIMENTAL
Other: Immediate HSCT Group

Bridging Therapy Group

ACTIVE COMPARATOR
Other: Bridging Therapy Group

Interventions

Immediate HSCT GroupOTHER

Patients undergo direct allogeneic HSCT.

Immediate HSCT Group
Bridging Therapy GroupOTHER

Patients receive one to two cycles of bridging therapy before undergoing allogeneic HSCT. o Bridging Therapy Regimen: Hypomethylating agents (HMA) alone or HMA-based combination chemotherapy, e.g., azacitidine (AZA) 100 mg/day + venetoclax (VEN) 400 mg/day for 7 days. Targeted therapies (e.g., IDH1 inhibitors) will be used for eligible patients.

Bridging Therapy Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • High relapse risk MDS, defined by:
  • IPSS-R score ≥3.5.
  • IPSS-M stratification as intermediate-high, high, or very high risk.
  • Eligible for allogeneic HSCT (including matched or mismatched related/unrelated donor transplantations).
  • Karnofsky Performance Status (KPS) ≥60.
  • Signed informed consent.

You may not qualify if:

  • Severe organ dysfunction:
  • Left ventricular ejection fraction \<50%.
  • Oxygen supplementation requirement.
  • Serum bilirubin \>1.5x upper limit of normal (unless due to Gilbert syndrome) or AST/ALT \>5x upper limit of normal.
  • Estimated glomerular filtration rate (eGFR) \<50 mL/min.
  • History of prior allogeneic HSCT.
  • Any condition deemed unsuitable by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Peking University People's Hospital

Beijin, Beijing Municipality, 100044, China

RECRUITING

Zhengzhou University First Affiliated Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army

Jinan, Shandong, China

RECRUITING

People's Liberation Army The General Hospital of Western Theater Command

Chengdu, Sichuan, 610083, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijia Zhuang, China

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Jiang Erlie, doctor

CONTACT

+86-15122538106jiangerlie@ihcams.ac.cn

Xiao Zhijian, doctor

CONTACT

+86-13821085716xiaozhijian@ihcams.ac.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

April 9, 2025

Study Start

July 24, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)