- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03596892
Decitabine+BUCY vs BUCY Conditioning Regimen for MLL+ Acute Leukemia Undergoing Allo-HSCT
July 13, 2018 updated by: Qifa Liu, Nanfang Hospital of Southern Medical University
Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
122
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qifa Liu
- Email: liuqifa628@163.com
Study Contact Backup
- Name: Qifa Liu
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Recruiting
- Department of Hematology,Nanfang Hospital, Southern Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Decitabine was administered at 20mg/m2/day on days -14 and -10.
|
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.
|
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
relapse rate
Time Frame: 2 year
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival (OS)
Time Frame: 2 year
|
2 year
|
disease-free survival (DFS)
Time Frame: 2 year
|
2 year
|
transplant-related mortality (TRM)
Time Frame: 2 year
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2018
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
July 13, 2018
First Submitted That Met QC Criteria
July 13, 2018
First Posted (Actual)
July 24, 2018
Study Record Updates
Last Update Posted (Actual)
July 24, 2018
Last Update Submitted That Met QC Criteria
July 13, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease Attributes
- Leukemia
- Acute Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Decitabine
- Busulfan
Other Study ID Numbers
- Dec+BUCYvsBUCY-MLL+ AL-2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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