- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03530085
Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT
December 18, 2020 updated by: Qifa Liu, Nanfang Hospital of Southern Medical University
Decitabine+ Fludarabine+Busulfan Conditioning Regimen for Elderly Acute Myeloid Leukemia in Complete Remission Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly acute myeloid leukemia (AML) in complete remission (CR).
At present, the best conditioning regimen for elderly AML in CR remains in discussion.
In this prospective study, the safety and efficacy of Dec+Flu+Bu myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly AML(older than 60 years) in complete remission (CR).
At present, the best conditioning regimen for elderly AML in CR remains in discussion.
Flu+Bu conditioning regimen is the most commonly used regimen for elderly AML in CR undergoing allo-HSCT.
However, it appears to have higher relapse rate.
To reduce the relapse rate, decitabine is added in the conditioning regimen.
In this prospective study, the safety and efficacy of Decitabine+ Fludarabine+Busulfan myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.
Study Type
Interventional
Enrollment (Anticipated)
60
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: Li Xuan
- Phone Number: 008615521251270
- Email: 356135708@qq.com
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
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- AML patients older than 60 years, younger than 80 years
- In complete remission before transplantation
- With HLA-matched sibling donors
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dec+Flu+Bu Conditioning Regimen
For AML patients older than 60 years in CR, Decitabine+ Fludarabine+Busulfan conditioning regimen was used (Decitabine 20mg/m2/day on days -9 to -7;Fludarabine(Flu) 30mg/m2/day on days -6 to -3;Busulfan (BU) 3.2 mg/kg/day on days -5 to -4).
|
Decitabine was administered at 20mg/m2/day on days -9 to -7.
Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.
Fludarabine(Flu) was administered at 30mg/m2/day on days -6 to -3.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival (OS)
Time Frame: 2 year
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
disease-free survival (DFS)
Time Frame: 2 year
|
2 year
|
transplant-related mortality (TRM)
Time Frame: 2 year
|
2 year
|
relapse
Time Frame: 2 year
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Qifa Liu, Department of hematology,Nanfang Hospital
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 (Actual)
June 15, 2018
Primary Completion (Anticipated)
April 1, 2021
Study Completion (Anticipated)
April 1, 2022
Study Registration Dates
First Submitted
May 8, 2018
First Submitted That Met QC Criteria
May 17, 2018
First Posted (Actual)
May 21, 2018
Study Record Updates
Last Update Posted (Actual)
December 22, 2020
Last Update Submitted That Met QC Criteria
December 18, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Decitabine
- Fludarabine
- Busulfan
Other Study ID Numbers
- Dec+FB-Elderly AML-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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