Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 55Years
All Genders
NCT03793517

Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT

Led by Peking University People's Hospital · Updated on 2020-03-10

55

Participants Needed

1

Research Sites

421 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Allogeneic haematopoietic stem cell transplantation (allo-HSCT) remains one of the currently available curative therapies for acute leukemia (AL). Leukemia relapse is one of the mainly causes of transplant failure. We reported previously that patients with high-risk molecular biomarkers who still have detectable minimal residual disease(MRD) pre-HSCT were at very high risk of relapse, with cumulative relapse rate of 50-80%. Decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastiv syndrome. It was reported that the combination of decitabine, with busufan and cyclophosphamide as a preparative regimen for allo-HSCT using HLA-matching donors was safe and effective. In this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mBU/CY) as a preparative regimen for allo-HSCT in patients with very high-risk AL and detectable MRD pre-HSCT.

CONDITIONS

Official Title

Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute leukemia patients with MLL-r, TLS-ERG, or SIL-TAL1 molecular markers
  • Detectable minimal residual disease before allogeneic hematopoietic stem cell transplantation
  • Age between 18 and 55 years
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Presence of uncontrolled severe infection

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University Institute of Hematology,Beijing

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

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Research Team

X

Xiao-Jun Huang

CONTACT

C

Chen-Hua Yan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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