Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT

Acute Myeloid Leukemia Clinical Trial

Official title:

Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03256071
• Other study ID #: DAC+BUCY
• 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
• 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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Allogeneic Hematopoietic Stem Cell Transplantation
• Conditioning
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

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