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RecruitingNCT06612944Updated Nov 26, 2024

Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification

A Phase 2 interventional study of Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Myelodysplastic Syndromes, Adult, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

By collecting interventional clinical data to assess the survival and relapse conditions of patients post-transplantation and comparing them with historical data, the primary study endpoint is the 1-year and 2-year relapse-free survival (RFS) post-transplantation. This includes the time from the start of treatment until the documentation of disease progression (bone marrow smear blast cells > 5% or extramedullary relapse) or death due to any cause, whichever occurs first. This experiment aims to improve the post-transplant survival rates of MDS patients classified as very high risk under the IPSS-M stratification and to explore pathways to prevent relapse.

02

Conditions studied

  • Myelodysplastic Syndromes, Adult
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In context

Myelodysplastic Syndromes

2,124 studies on the registry are indexed under Myelodysplastic Syndromes; 320 are open to participants now.

This study's planned enrollment of 40 is close to the median of 39 across 1,740 interventional studies indexed under Myelodysplastic Syndromes.

Browse Myelodysplastic Syndromes studies →

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 173 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age between 18 and 70 years, inclusive, both male and female. Diagnosed with MDS according to WHO criteria and classified as very high-risk by IPSS-M scoring. The patient must have a suitable hematopoietic stem cell donor for allogeneic transplantation: Related donors must be at least 5/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1
  2. Unrelated donors must be at least 8/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score of ≤ 2. ECOG performance status of 0-2. Adequate liver, kidney, cardiac, and pulmonary functions as follows: Serum creatinine ≤ 1.5× upper limit of normal (ULN)
  3. Cardiac function: Ejection fraction ≥ 50%
  4. Baseline oxygen saturation > 92%
  5. Total bilirubin ≤ 1.5× ULN
  6. ALT and AST ≤ 2.0× ULN
  7. Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 ≥ 50%. Patients must be capable of understanding and willing to participate in the study, and must sign an informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Failure to proceed with stem cell reinfusion after unsuccessful pre-transplant conditioning. History of previous hematopoietic stem cell transplantation (HSCT). ECOG performance status > 2. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3. Any unstable systemic disease including, but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack within the past 3 months, myocardial infarction within the past 3 months, congestive heart failure (New York Heart Association [NYHA] class ≥ III), post-pacemaker implantation requiring medication for severe arrhythmias, severe liver, kidney, or metabolic diseases
  2. patients with pulmonary arterial hypertension. Active, uncontrolled infection: hemodynamic instability related to infection, new symptoms or signs of worsening infection, radiological evidence of new infectious foci, persistent fever without signs or symptoms that cannot exclude infection. Need for treatment for Grade ≥2 epilepsy, paralysis, aphasia, new cerebral infarction, severe brain trauma, dementia, Parkinson\'s disease, schizophrenia. HIV infection. Active hepatitis B (HBV) or hepatitis C (HCV) requiring antiviral treatment
  3. patients at risk of HBV reactivation, indicated by positive hepatitis B surface antigen or core antibody without antiviral therapy for hepatitis B. Pregnant or breastfeeding women. Men and women of childbearing potential unwilling to use contraception during the treatment and for 12 months post-treatment. Allergic to intervention drugs such as azacitidine, decitabine, or venetoclax.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    Drug: Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation

Interventions

  • DrugProphylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation

    1.1 AZA + BCL2 Inhibitor (Preferred Regimen) Subcutaneous injection of azacitidine at 32 mg/m² per day for 5 consecutive days, with a 28-day cycle; BCL2 inhibitor (VEN): 400 mg per day orally for one week (if combined with a CYP450 inhibitor, reduce to 100 mg per day). 1.2 AZA (DEC) + DLI For patients with TP53 mutations or those who do not respond to VEN, subcutaneous injection of azacitidine at 32 mg/m² per day for 5 consecutive days, with a 28-day cycle; decitabine at 5 mg/m² per day for 5 consecutive days, with a 28-day cycle (preferred for those with TP53 mutations). For patients without the option for DLI, regimen 1.1 is recommended. DLI: Begins 3 months post-transplantation, starting with a dose of 1×10\^5 CD3+ T lymphocytes for haploidentical transplants, with doses increasing every 4-6 weeks to 5×10\^5 CD3+ T lymphocytes, 1×10\^6 CD3+, and 5×10\^6 CD3+ T lymphocytes; for full-matched transplants, the starting dose is 5×10\^5 CD3+ T lymphocytes with dose escalations as above to 1×1

06

What researchers measure

Primary outcomes

  1. RFS:relapse-free survival

    Time frame: 1 year

  2. RFS:relapse- free survival

    Time frame: 2 year

Secondary outcomes

  1. OS:overall survival

    Time frame: 1 year

  2. OS:overall survival

    Time frame: 2 year

07

Study locations

1 of 1 sites recruiting
  • Shanghai General Hospital
    Shanghai, 200080, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06612944
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Xianmin Song, MD (Clinical Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Sep 25, 2024
Start date
Nov 12, 2024
Primary completion
Nov 12, 2027 (estimated)
Completion
Nov 12, 2028 (estimated)
Last update
Nov 26, 2024

Study contacts

Xianmin Song, MD
Contact
shongxm@139.com
+8613501672508

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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