Peking University Institute of Hematology,Beijing
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
Location contact
Chen-hua Yan, MD
CONTACT
Xiao-Jun Huang, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT03793517
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Phase 2 / Phase 3
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
Chen-hua Yan, MD
CONTACT
Xiao-Jun Huang, MD
PRINCIPAL_INVESTIGATOR
Patients enrolled in this study would receive decitabine 200mg·m-2·d-1 on day -12 and -11 pre-HSCT. The conditioning therapy for human leukocyte antigen (HLA)-mismatched HSCT patients was modified BU/CY plus ATG (thymoglobulin; Sang Stat, France) consisting of cytarabine (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, semustine (Me-CCNU, 250 mg·m-2), orally once on day -3, and ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2. In matched sibling transplantations, patients received hydroxycarbamide (80 mg·kg-1) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, but otherwise an identical regimen to the HLA-mismatched patients without ATG.
BM samples from patients were obtained to assess leukemia status after HSCT. The time points that we monitored BM samples included at time of allo-HSCT; 1 month, 2 months, 3 months, 4.5 months, 6 months, 9 months, and 12 months after allo-HSCT; and every 6 months thereafter to the defined endpoints or for at least until 5 years after transplantation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Decitabine 200mg.m-2.d-1 intervanously on days -12 and -11
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
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
Time frame: 1 year post allo-HSCT
The cumulative incidence of relapse at 1 year post allo-HSCT
Time frame: 2 years post allo-HSCT
The cumulative incidence of relapse at 2 years post allo-HSCT
Time frame: 1 year post allo-HSCT
The cumulative incidence of non-relapse mortality at 1 year post allo-HSCT
Time frame: 1 year post allo-HSCT
The overall survival at 1 year post allo-HSCT
Time frame: 5 years post allo-HSCT
The overall survival at 5 years post allo-HSCT
Time frame: 1 year post allo-HSCT
The leukemia free survival at 1 years post allo-HSCT
Time frame: 5 years post allo-HSCT
The leukemia free survival at 5 years post allo-HSCT
Time frame: 100 days post allo-HSCT
The total neutrophil and platelet engraftment rate
Time frame: 100 days post allo-HSCT
The cumulative incidence of grade II-IV acute graft versus host disease
Time frame: 1 years post allo-HSCT
The cumulative incidence of intermediate to severe chronic graft versus host disease
Contact information is provided by the study sponsor or research team.
Chen-Hua Yan
CONTACT
Xiao-Jun Huang
CONTACT
Peking University People's Hospital
Other
Decitabine Plus mBU/CY for High Risk Acute Leukemia With Minimal Residual Disease Pre-HSCT
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