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A clinical study on the efficacy and safety of low-dose HHT combined with Venetoclax sequential allogeneic hematopoietic stem cell transplantation in the treatment of R/R AML and high-risk MDS

A clinical study on the efficacy and safety of low-dose HHT combined with Venetoclax sequential allogeneic hematopoietic stem cell transplantation in the treatment of R/R AML and high-risk MDS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080442
Enrollment
Unknown
Registered
2024-01-29
Start date
2024-01-29
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R/R AML and high-risk MDS

Interventions

experimental group:low-dose HHT combined with Venetoclax sequential allogeneic hematopoietic stem cell transplantation

Sponsors

The Second Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1: R/R AML and high-risk MDS was clearly diagnosed according to WHO criteria 2: Aged 18 to 65 years 3: ECOG physical condition score was <= 3 4: No serious complications, such as liver failure, renal failure, heart failure 5: Must be able to understand the protocol, follow medical instructions and sign informed consent.

Exclusion criteria

Exclusion criteria: 1: Who is receiving either a chemotherapy regimen or a targeted drug 2: Major surgery (excluding diagnostic surgery) performed within the past 4 weeks 3: Evidence of central nervous system disease 4: Active infectious diseases, such as HBV, HCV, tuberculosis 5: Serious diseases that may limit patients' participation in the trial (such as progressive infection, uncontrolled diabetes, severe cardiac insufficiency or myocardial infarction, liver and kidney dysfunction, etc) 6: Participating in other clinical trials or participating in clinical trials of other drugs within 3 months 7: Women of childbearing age must have a negative pregnancy test and agree to use effective contraception during treatment and within a year thereafter 8: There are allergies or contraindications to any of the drugs involved in the protocol 9: Unable to understand the experimental protocol, follow the doctor's advice, or refuse to sign the informed consent 10: The researchers say it is not appropriate for patients who are treated with this regimen.

Design outcomes

Primary

MeasureTime frame
1-year overall survival rate;

Secondary

MeasureTime frame
1-year leukemia-free survival rate;recurrent rate;Non-recurrent mortality;Drug-related toxicity;Graft versus host disease;Infectious diseases after transplantation;

Countries

China

Contacts

Public ContactJinsong Yan

Second Hospital of Dalian Medical University

yanjsdmu@126.com+86 177 0987 1028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026