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Decitabine+BUCY vs BUCY Conditioning Regimen for MLL+ Acute Leukemia Undergoing Allo-HSCT

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ClinicalTrials.gov Identifier: NCT03596892
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborators:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou First People's Hospital
Peking University People's Hospital
Zhujiang Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Brief Summary:
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.

Condition or disease Intervention/treatment Phase
Allogeneic Hematopoietic Stem Cell Transplantation Conditions Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia Drug: Decitabine Drug: Busulfan (BU) Drug: Cyclophosphamide (CY) Phase 2 Phase 3

Detailed Description:
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. BUCY conditioning regimen is the standard myeloablative regimen for MLL+ acute leukemia undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: Decitabine + BUCY
For MLL+ acute leukemia undergoing allo-HSCT,Decitabine+BUCY conditioning regimen was Decitabine 20mg/m2/day on days -14 and -10; Busulfan (BU) 3.2 mg/kg/day on days -7 and -4;Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2.
Drug: Decitabine
Decitabine was administered at 20mg/m2/day on days -14 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 MLL+ acute leukemia undergoing allo-HSCT,BUCY conditioning regimen was Busulfan (BU) 3.2 mg/kg/day on days -7 and -4;Cyclophosphamide (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. 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 ]


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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:

  • MLL+ acute leukemia undergoing allo-HSCT
  • 14-65 years

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): NCT03596892


Contacts
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Contact: Qifa Liu liuqifa628@163.com
Contact: Qifa Liu

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Li Xuan    +86-020-62787883    356135708@qq.com   
Principal Investigator: Qifa Liu         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou First People's Hospital
Peking University People's Hospital
Zhujiang Hospital
Third Affiliated Hospital, 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: NCT03596892     History of Changes
Other Study ID Numbers: Dec+BUCYvsBUCY-MLL+ AL-2018
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Cyclophosphamide
Busulfan
Decitabine
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
Enzyme Inhibitors