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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03256071
Other study ID # DAC+BUCY
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received May 21, 2017
Last updated August 18, 2017
Start date September 2017
Est. completion date September 2021

Study information

Verified date May 2017
Source The First Affiliated Hospital of Soochow University
Contact Xiaowen Tang, MD
Phone +86-512-67781851
Email xwtang1020@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date September 2021
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Decitabine plus Modified BUCY
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.
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.

Locations

Country Name City State
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (5)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University Jiangsu University, Southeast University, China, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary disease-free survival (DFS) time from randomization to the first of reccurrence or death 3 year
Primary overall survival (OS) time from randomization to death from any cause 3 year
Secondary veno-occlusive disease (VOD) incidence of veno-occlusive disease (VOD) events 3 year
Secondary graft-versus-host disease (GvHD) incidence and severity of acute (aGvHD) and chronic graft-versus-host disease (cGvHD) 3 year
Secondary transplant related mortality (TRM) cumulative incidence of transplant related mortality 3 year
Secondary relapse cumulative incidence of relapse 3 year
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