RecruitingPhase 2Phase 3NCT03793517

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

Decitabine Plus mBU/CY for High Risk Acute Leukemia With Minimal Residual Disease Pre-HSCT


Sponsor

Peking University People's Hospital

Enrollment

55 participants

Start Date

Sep 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called decitabine — a medication that works by reprogramming how genes are read in cancer cells — to a standard pre-transplant chemotherapy regimen (called mBU/CY) can improve outcomes for patients with high-risk leukemia who still have detectable cancer cells (called minimal residual disease or MRD) before their stem cell transplant. MRD-positive patients face higher relapse risk after transplant, so researchers are looking for better conditioning strategies to eliminate more cancer cells before transplantation. **You may be eligible if...** - You have acute leukemia with specific high-risk genetic features (such as MLL-rearrangement, TLS-ERG, or SIL-TAL1 gene abnormalities) - Minimal residual disease — small traces of cancer cells — can still be detected in your body before the transplant **You may NOT be eligible if...** - You are pregnant - You have a severe, uncontrolled infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDecitabine

Decitabine 200mg.m-2.d-1 intervanously on days -12 and -11

DRUGmBU/CY and ATG

Ara-C 4 g·m-2·d-1 intravenously on days -10 to -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Simustine (Me-CCNU, 250 mg·m-2) orally once on day -3 ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2

DRUGmBU/CY

hydroxycarbamide (80 mg·kg-1) orally on day -10 Ara-C (2 g·m-2·d-1) on day -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Simustine (Me-CCNU, 250 mg·m-2) orally once on day -3


Locations(1)

Peking University Institute of Hematology,Beijing

Beijing, Beijing Municipality, China

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NCT03793517


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