Decitabine + BUCY vs BUCY Conditioning Regimen for Myeloi... | NCT04098653

Studies
Decitabine + BUCY vs BUCY Conditioning Regimen for Myeloid Tumors Undergoing Allo-HSCT

NCT04098653

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

Sep 23, 2019Actual

Enrollment

196Estimated

Phase

Phase 2Phase 3

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation
Conditioning
Myeloid Tumors

Interventions

Decitabine
Busulfan (BU)
Cyclophosphamide (CY)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2019Estimated

Primary Completion Date

Aug 2022Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Sep 19, 2019

First Submission Date that Met QC Criteria

Sep 19, 2019

First Posted Date

Sep 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2019

Last Update Posted Date

Sep 23, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Qifa Liu, Professor, Nanfang Hospital, Southern Medical UniversityPrincipal Investigator

Lead Sponsor

Nanfang Hospital, Southern Medical UniversityOTHER

Collaborators

Name	Class
Peking University People's Hospital	OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	OTHER
Third Affiliated Hospital, Sun Yat-Sen University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. 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 myeloid tumors undergoing allo-HSCT are evaluated.

Detailed Description

Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. BUCY conditioning regimen is the standard myeloablative regimen for myeloid tumors 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 myeloid tumors undergoing allo-HSCT are evaluated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

196Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Decitabine + BUCY	Experimental	For myeloid tumors 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 Drug: Busulfan (BU) Drug: Cyclophosphamide (CY)
BUCY	Active Comparator	For myeloid tumors 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) Drug: Cyclophosphamide (CY)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Decitabine	Drug	Decitabine was administered at 20mg/m2/day on days -14 and -10.	Decitabine + BUCY

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
relapse rate		1 year

Secondary Outcomes

Measure	Description	Time Frame
overall survival (OS)		1 year
disease-free survival (DFS)		1 year
transplant-related mortality (TRM)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Myeloid tumors 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qifa Liu	Contact	020-61641611		liuqifa628@163.com

Overall Officials

Name	Affiliation	Role
Qifa Liu	Nanfang Hospital, Southern Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hematology,Nanfang Hospital, Southern Medical University	Recruiting	Guangzhou	Guangdong	510515	China

Intervention Browse Module

MeSH Terms

ID	Term
D000077209	Decitabine
D002066	Busulfan
D003520	Cyclophosphamide

Ancestor Terms

ID	Term
D001374	Azacitidine
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine

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