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

NCT03256071 | Unknown Phase 2

• 1 other identifier: DAC+BUCY
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Myeloid Leukemia; Allogeneic Hematopoietic Stem Cell Transplantation; Conditioning

Outcome Measures

Primary Outcomes (2)

• disease-free survival (DFS)

  time from randomization to the first of reccurrence or death

  3 year

• overall survival (OS)

  time from randomization to death from any cause

  3 year

Secondary Outcomes (4)

• veno-occlusive disease (VOD)

  3 year

• graft-versus-host disease (GvHD)

  3 year

• transplant related mortality （TRM）

  3 year

• relapse

  3 year

Study Arms (2)

Decitabine plus Modified BUCY

EXPERIMENTAL

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.

Drug: Decitabine plus Modified BUCY

Modified BUCY

ACTIVE COMPARATOR

For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Modified BuCy regimen consisted of semustine,cytarabine, busulfan and cyclophosphamide.

Drug: Modified BUCY

Interventions

Decitabine plus Modified BUCY DRUG

Decitabine:20 mg/m²/day on day -14 to -10; Modified BUCY: 1. 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. 2. 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. 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.

Decitabine plus Modified BUCY

Modified BUCY DRUG

1. 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. 2. 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. 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

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Jiangsu University: collaborator
• Xuzhou Medical University: collaborator
• Southeast University, China: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Depei Wu, MD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaowen Tang, MD

CONTACT

+86-512-67781851; xwtang1020@163.com

Depei Wu, MD

CONTACT

+86-512-67781851; wudepei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: August 21, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: August 21, 2017

Record last verified: 2017-05

Locations

CN (1)