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IDA+BUCY vs BUCY Conditioning Regimen for Intermediate-risk AML Undergoing Auto-HSCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671708
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : March 3, 2020
Sponsor:
Collaborators:
Third Affiliated Hospital, Sun Yat-Sen University
Peking University People's Hospital
Zhujiang Hospital
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Brief Summary:
Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to allogeneic HSCT for intermediate-risk acute myeloid leukemia (AML) without HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML undergoing auto-HSCT are evaluated.

Condition or disease Intervention/treatment Phase
Autologous Hematopoietic Stem Cell Transplantation Acute Myeloid Leukemia Conditioning Drug: Idarubicin(IDA) Drug: Busulfan (BU) Drug: Cyclophosphamide (CY) Phase 2 Phase 3

Detailed Description:
Auto-HSCT is an effective alternative to allogeneic HSCT for intermediate-risk AML without HLA-matched donors. BUCY conditioning regimen is the standard myeloablative regimen. However, auto-HSCT with BUCY conditioning regimen appears to have higher relapse rate. To reduce the relapse rate, IDA is added in the conditioning regimen. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML patients undergoing auto-HSCT are evaluated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Idarubicin+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Intermediate-risk Acute Myeloid Leukemia Undergoing Autologous Hematopoietic Stem Cell Transplantation
Study Start Date : January 2016
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2020


Arm Intervention/treatment
Experimental: IDA+BUCY
For intermediate-risk AML undergoing auto-HSCT,IDA+BUCY conditioning regimen was IDA 15mg/m2/day on days -12 and -10;BU 3.2 mg/kg/day on days -7 and -4;CY 60 mg/kg/day on days -3 and -2.
Drug: Idarubicin(IDA)
Idarubicin was administered at 15mg/m2/day on days -12 and -10.

Drug: Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

Drug: Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

Active Comparator: BUCY

For intermediate-risk AML undergoing auto-HSCT,BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4;CY 60 mg/kg/day on days

-3 and -2.

Drug: Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

Drug: Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.




Primary Outcome Measures :
  1. leukemia relapse rate [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 2 year ]
  2. disease-free survival (DFS) [ Time Frame: 2 year ]
  3. transplant-related mortality (TRM) [ Time Frame: 2 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intermediate-risk AML
  • Achieving CR after one cycle induction,then receiving three cycles of consolidation therapy including moderate and high doses of Ara-c combined regimens
  • With negative MRD before mobilization and collect of peripheral blood stem cells
  • Without HLA-matched donors (related and unrelated)
  • Refusal of haploidentical hematopoietic stem cell transplantation

Exclusion Criteria:

  • Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  • Patients with any conditions not suitable for the trial (investigators' decision)

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): NCT02671708


Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Third Affiliated Hospital, Sun Yat-Sen University
Peking University People's Hospital
Zhujiang Hospital
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University
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Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02671708    
Other Study ID Numbers: IDA+BUCY vs BUCY-AML-2016
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cyclophosphamide
Busulfan
Idarubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors