- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05449899
G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for Secondary Acute Myeloid Leukemia Undergoing Allo-HSCT
July 5, 2022 updated by: Xuanli, Nanfang Hospital of Southern Medical University
G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With Secondary Acute Myeloid Leukemia Evolving From MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Allo-HSCT is the most effective way to cure sAML patients.
At present, the best conditioning regimen for sAML patients undergoing allo-HSCT remains in discussion.
In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in sAML patients undergoing allo-HSCT are evaluated.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Allo-HSCT is the most effective way to cure secondary acute myeloid leukemia evolving from MDS (sAML) patients.
At present, the best conditioning regimen for sAML patients undergoing allo-HSCT remains in discussion.
Our previous study has showed that G-CSF+DAC+BUCY conditioning regimen could reduce the relapse and improve the survival compared with BUCY conditioning regimen, while the two conditioning regimens both have high non-relapse mortality (NRM).
Several retrospective and prospective studies including ours have demonstrated that BF conditioning regimen has a lower NRM compared with BUCY conditioning regimen, while the relapse and survival are similar in patients undergoing BF and BUCY conditioning regimens.
Based on the above, we design the prospective randomized controlled study to evaluate the safety and efficacy of G-CSF+DAC+ BUCY and G-CSF+DAC+BF conditioning regimens in sAML patients undergoing allo-HSCT.
Study Type
Interventional
Enrollment (Anticipated)
232
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 Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Recruiting
- Department of Hematology,Nanfang Hospital, Southern Medical University
-
Contact:
- Li Xuan
- Phone Number: 15521251270
- Email: 356135708@qq.com
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Had a diagnosis of sAML
- Age 18 to 65 years old
- ECOG performance status of 0-2
- HCT-CI of 0-2
- Were willing to undergo allo-HSCT
Exclusion Criteria:
- Therapy-related MDS
- Previous allo-HSCT
- Uncontrolled infections
- Liver or renal dysfunction
- Severe concomitant conditions not suitable for the trial
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: G-CSF+DAC+BF
For patients with sAML undergoing allo-HSCT, Granulocyte Colony-Stimulating Factor (G-CSF)+Decitabine+BF conditioning regimen was G-CSF 5ug/kg/day on days -17 to -10 (when white blood cell is more than 20G/L, stop using G-CSF), Decitabine 20mg/m2/day on days -14 to -10, Busulfan (BU) 3.2 mg/kg/day on days -6 to -3, Fludarabine (FLU) 30mg/m2/ day on days -7 to -3.
|
G-CSF was administered at 5 ug/kg/day on days-17 to -10.
When white blood cell is more than 20G/L, stop using G-CSF.
Decitabine was administered at 20mg/m2/day on days -14 to -10.
Fludarabine was administered at 30 mg/m2/day on days -7 to -3.
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group, and it was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group .
|
Active Comparator: G-CSF+DAC+BUCY
For patients with sAML undergoing allo-HSCT, Granulocyte Colony -Stimulating Factor (G-CSF)+Decitabine+BUCY conditioning regimen was G-CSF 5ug/kg/day on days -17 to -10 (when white blood cell is more than 20G/L, stop using G-CSF), Decitabine 20mg/m2/day on days -14 to -10, Busulfan (BU) 3.2 mg/kg/day on days -7 to -4, Cyclophosphamide (CY) 60 mg/kg/day on days -3, -2.
|
G-CSF was administered at 5 ug/kg/day on days-17 to -10.
When white blood cell is more than 20G/L, stop using G-CSF.
Decitabine was administered at 20mg/m2/day on days -14 to -10.
Cyclophosphamide was administered at 60 mg/kg/day on days -3,-2.
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group, and it was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Non-relapse mortality (NRM)
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS)
Time Frame: 1 year
|
1 year
|
Cumulative incidence of relapse
Time Frame: 1 year
|
1 year
|
Disease-free survival (DFS)
Time Frame: 1 year
|
1 year
|
Adverse effects
Time Frame: within 100 days post-transplantation
|
within 100 days post-transplantation
|
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, 2022
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
July 5, 2022
First Submitted That Met QC Criteria
July 5, 2022
First Posted (Actual)
July 8, 2022
Study Record Updates
Last Update Posted (Actual)
July 8, 2022
Last Update Submitted That Met QC Criteria
July 5, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplastic Processes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Neoplasm Metastasis
- 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
- Adjuvants, Immunologic
- Cyclophosphamide
- Decitabine
- Lenograstim
- Fludarabine
- Busulfan
Other Study ID Numbers
- DAC-BUCY vs DAC-BF-sAML-2022
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.
Clinical Trials on Allogeneic Hematopoietic Stem Cell Transplantation
-
University Hospital, GenevaRecruitingAllogeneic Hematopoietic Stem Cell Transplantation | Hematopoietic Stem Cell Transplantation | Autologous Hematopoietic Stem Cell TransplantationSwitzerland
-
Universitaire Ziekenhuizen KU LeuvenUnknownHematopoietic Stem Cell Transplantation | Hematopoietic Stem Cell Transplantation, Allogeneic
-
Sidney Kimmel Cancer Center at Thomas Jefferson...National Cancer Institute (NCI)TerminatedALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONUnited States
-
Fujian Medical UniversityRecruitingAllogeneic Hematopoietic Stem Cell TransplantationChina
-
Central Hospital, Nancy, FranceRecruitingAllogeneic Hematopoietic Stem Cell TransplantationFrance
-
Medical College of WisconsinNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsCompletedAllogeneic Hematopoietic Stem Cell TransplantationUnited States
-
Cairo UniversityCompletedAllogeneic Hematopoietic Stem Cell TransplantationEgypt
-
Universitätsklinikum Hamburg-EppendorfStaburo GmbH; Deutsche José Carreras Leukämie-StiftungUnknownAllogeneic Hematopoietic Stem Cell TransplantationGermany
-
Shandong Provincial HospitalUnknownAllogeneic Hematopoietic Stem Cell Transplantation | EltrombopagChina
-
Ohio State University Comprehensive Cancer CenterRecruitingAllogeneic Hematopoietic Stem Cell Transplantation RecipientUnited States
Clinical Trials on Granulocyte Colony-Stimulating Factor(G-CSF)
-
Ottawa Hospital Research InstituteRecruiting
-
Catholic University of the Sacred HeartWithdrawn
-
University Hospital MuensterCompletedAmyotrophic Lateral Sclerosis | Chronic StrokeGermany
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingBreast Ductal Carcinoma In SituUnited States
-
Hospital Sao RafaelCompletedChronic Chagasic MyocarditisBrazil
-
TECAM GroupHospital General Universitario Gregorio MarañonUnknownReperfused Acute Myocardial InfarctionSpain
-
University of Mississippi Medical CenterUnknownPediatric Cancer | Chemotherapy-Induced Febrile Neutropenia | Chemotherapy-induced Neutropenia | Granulocyte Colony-Stimulating FactorUnited States
-
Xiamen Amoytop Biotech Co., Ltd.Shanghai Jiao Tong University Affiliated First People's HospitalCompleted
-
Serhat Gumrukcu, MD PhDFrida Therapeutics LLCRecruiting
-
Lei LiRecruitingFebrile Neutropenia | Epithelial Ovarian Cancer | Adverse Event | Cost-effectiveness | Myelosuppression Adult | Colony Stimulating FactorsChina