Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorPeking University People's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
acute leukemia patients with MLL-r,TLS-ERG,or SIL-TAL1,whose minimal residual disease were detectable pre-HSCT
Disqualifiers
pregnancy women
uncontrolled severe infection
Trial design
Design model
Single group
Treatments tested in this trial
Decitabine
DrugDecitabine 200mg.m-2.d-1 intervanously on days -12 and -11
mBU/CY and ATG
DrugAra-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
mBU/CY
Drughydroxycarbamide (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
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: Decitabine plus mBU/CY for HLA-mismatched HSCTExperimental treatment 2 interventions
Group B: Decitabine plus mBU/CY for matched sibling transplantExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
1 year cumulative incidence of relapse
The cumulative incidence of relapse at 1 year post allo-HSCT
Time frame
1 year post allo-HSCT2
2 year cumulative incidence of relapse
The cumulative incidence of relapse at 2 years post allo-HSCT
Time frame
2 years post allo-HSCTSecondary outcomes
1
Non-relapse mortality
The cumulative incidence of non-relapse mortality at 1 year post allo-HSCT
Time frame
1 year post allo-HSCT2
1 year overall survival
The overall survival at 1 year post allo-HSCT
Time frame
1 year post allo-HSCT3
5 years overall survival
The overall survival at 5 years post allo-HSCT
Time frame
5 years post allo-HSCT4
1 year leukemia free survival
The leukemia free survival at 1 years post allo-HSCT
Time frame
1 year post allo-HSCTSponsors and contacts
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Source ClinicalTrials.gov