Back to resultsLow Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT
Primary Purpose
Acute Myeloid Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Decitabine plus Modified BUCY
Modified BUCY
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- Age 12 to 60 years.
- Diagnosis of high-risk acute myeloid leukemia at the time of transplant. ("High-risk" AML features are defined by the following: relapsed or primary refractory AML; Secondary AML（AML Secondary to myelodysplastic syndrome(MDS) or treatment-related AML); extramedullary leukemia; adverse cytogenetic abnormalities of monosomy 5, monosomy 7, or deletion of 5q; or presence of FLT3 positive internal tandem duplication (FLT3/ITD+), particularly high allelic ratio.)
- Patient must have adequate pre-transplant organ function.
Exclusion Criteria:
- Age <12 or >60 years.
- Uncontrolled bacterial, viral, fungal, or other infection before conditioning regimen.
- Any other severe concurrent diseases, or have a history of serious organ dysfunction.
- Pregnant or lactating females.
Sites / Locations
- The First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Decitabine plus Modified BUCY
Modified BUCY
Arm Description
For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Decitabine plus Modified BuCy regimen consisted of decitabine,semustine,cytarabine, busulfan and cyclophosphamide.
For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Modified BuCy regimen consisted of semustine,cytarabine, busulfan and cyclophosphamide.
Outcomes
Primary Outcome Measures
disease-free survival (DFS)
time from randomization to the first of reccurrence or death
overall survival (OS)
time from randomization to death from any cause
Secondary Outcome Measures
veno-occlusive disease (VOD)
incidence of veno-occlusive disease (VOD) events
graft-versus-host disease (GvHD)
incidence and severity of acute (aGvHD) and chronic graft-versus-host disease (cGvHD)
transplant related mortality （TRM）
cumulative incidence of transplant related mortality
relapse
cumulative incidence of relapse
Full Information
NCT ID
NCT03256071
First Posted
May 21, 2017
Last Updated
August 18, 2017
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Jiangsu University, Xuzhou Medical University, Southeast University, China
1. Study Identification
Unique Protocol Identification Number
NCT03256071
Brief Title
Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT
Official Title
Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Jiangsu University, Xuzhou Medical University, Southeast University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this prospective, open-label, randomized multicenter study is to evaluate the safety and efficacy of low dose decitabine in combination with modified BUCY vs modified BUCY as a myeloablative conditioning regimen for high-risk patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
Detailed Description
Allo-HSCT is the most effective treatment stratagey for high risk acute myeloid leukemia. At present, modified BUCY is the standard conditioning regimen for AML undergoing allo-HSCT in our institute. However, relapse occured in as high as 30-50% high risk AML patients after allo-HSCT. Thus, the best conditioning regimen for this subgroup remains to be optimized. Low dose decitabine in combination with chemotherapy have been shown to improve comple remission rate of high risk AML patients. To reduce the relapse rate after allo-HSCT, low dose decitabine is added in the modified BUCY regimen. In this study, the safety and efficacy of low dose decitabine + modified BUCY vs modified BUCY myeloablative conditioning regimens in high risk undergoing allo-HSCT are evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Decitabine plus Modified BUCY
Arm Type
Experimental
Arm Description
For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Decitabine plus Modified BuCy regimen consisted of decitabine,semustine,cytarabine, busulfan and cyclophosphamide.
Arm Title
Modified BUCY
Arm Type
Active Comparator
Arm Description
For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Modified BuCy regimen consisted of semustine,cytarabine, busulfan and cyclophosphamide.
Intervention Type
Drug
Intervention Name(s)
Decitabine plus Modified BUCY
Intervention Description
Decitabine:20 mg/m²/day on day -14 to -10;
Modified BUCY:
Sibling:semustine 250 mg/m²/day on day -9;cytarabine 2 g/m²/day on day -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
Unrelated:semustine 250 mg/m²/day on day -10;cytarabine 2 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
Haploidentical:semustine 250 mg/m²/day on day -10;cytarabine 4 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
Intervention Type
Drug
Intervention Name(s)
Modified BUCY
Intervention Description
Sibling:semustine 250 mg/m²/day on day -9;cytarabine 2 g/m²/day on day -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
Unrelated:semustine 250 mg/m²/day on day -10;cytarabine 2 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
Haploidentical:semustine 250 mg/m²/day on day -10;cytarabine 4 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
Primary Outcome Measure Information:
Title
disease-free survival (DFS)
Description
time from randomization to the first of reccurrence or death
Time Frame
3 year
Title
overall survival (OS)
Description
time from randomization to death from any cause
Time Frame
3 year
Secondary Outcome Measure Information:
Title
veno-occlusive disease (VOD)
Description
incidence of veno-occlusive disease (VOD) events
Time Frame
3 year
Title
graft-versus-host disease (GvHD)
Description
incidence and severity of acute (aGvHD) and chronic graft-versus-host disease (cGvHD)
Time Frame
3 year
Title
transplant related mortality （TRM）
Description
cumulative incidence of transplant related mortality
Time Frame
3 year
Title
relapse
Description
cumulative incidence of relapse
Time Frame
3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 12 to 60 years.
Diagnosis of high-risk acute myeloid leukemia at the time of transplant. ("High-risk" AML features are defined by the following: relapsed or primary refractory AML; Secondary AML（AML Secondary to myelodysplastic syndrome(MDS) or treatment-related AML); extramedullary leukemia; adverse cytogenetic abnormalities of monosomy 5, monosomy 7, or deletion of 5q; or presence of FLT3 positive internal tandem duplication (FLT3/ITD+), particularly high allelic ratio.)
Patient must have adequate pre-transplant organ function.
Exclusion Criteria:
Age <12 or >60 years.
Uncontrolled bacterial, viral, fungal, or other infection before conditioning regimen.
Any other severe concurrent diseases, or have a history of serious organ dysfunction.
Pregnant or lactating females.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaowen Tang, MD
Phone
+86-512-67781851
Email
xwtang1020@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Depei Wu, MD
Phone
+86-512-67781851
Email
wudepei@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Depei Wu, MD
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, MD
Phone
+86-512-67781851
Email
xwtang1020@163.com
First Name & Middle Initial & Last Name & Degree
Depei Wu, MD
12. IPD Sharing Statement
Learn more about this trial
Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT
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