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

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ClinicalTrials.gov Identifier: NCT03256071
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Jiangsu University
Xuzhou Medical University
Southeast University, China
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

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).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Allogeneic Hematopoietic Stem Cell Transplantation Conditioning Drug: Decitabine plus Modified BUCY Drug: Modified BUCY Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
Experimental: Decitabine plus Modified BUCY
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

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.

Active Comparator: Modified BUCY
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
  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.




Primary Outcome Measures :
  1. disease-free survival (DFS) [ Time Frame: 3 year ]
    time from randomization to the first of reccurrence or death

  2. overall survival (OS) [ Time Frame: 3 year ]
    time from randomization to death from any cause


Secondary Outcome Measures :
  1. veno-occlusive disease (VOD) [ Time Frame: 3 year ]
    incidence of veno-occlusive disease (VOD) events

  2. graft-versus-host disease (GvHD) [ Time Frame: 3 year ]
    incidence and severity of acute (aGvHD) and chronic graft-versus-host disease (cGvHD)

  3. transplant related mortality (TRM) [ Time Frame: 3 year ]
    cumulative incidence of transplant related mortality

  4. relapse [ Time Frame: 3 year ]
    cumulative incidence of relapse



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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256071


Contacts
Contact: Xiaowen Tang, MD +86-512-67781851 xwtang1020@163.com
Contact: Depei Wu, MD +86-512-67781851 wudepei@163.com

Locations
China, Jiangsu
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215000
Contact: Xiaowen Tang, MD    +86-512-67781851    xwtang1020@163.com   
Principal Investigator: Depei Wu, MD         
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Jiangsu University
Xuzhou Medical University
Southeast University, China
Investigators
Principal Investigator: Depei Wu, MD The First Affiliated Hospital of Soochow University

Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03256071     History of Changes
Other Study ID Numbers: DAC+BUCY
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: May 2017

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cyclophosphamide
Cytarabine
Busulfan
Semustine
Decitabine
Azacitidine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors