Effect of Chemotherapy vs No Chemotherapy Pre-transplant... | NCT02850822

Studies
Effect of Chemotherapy vs No Chemotherapy Pre-transplant to MDS Undergoing Allo-HSCT

NCT02850822

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

Dec 8, 2017Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Myelodysplastic Syndrome
Chemotherapy

Interventions

Demethylation drug
Chemotherapy regimen

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

Jul 2016

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

Jul 2016

Primary Completion Date

Jun 2019Estimated

Completion Date

Jun 2020Estimated

First Submitted Date

Jul 20, 2016

First Submission Date that Met QC Criteria

Jul 29, 2016

First Posted Date

Aug 1, 2016Estimated

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

Dec 6, 2017

Last Update Posted Date

Dec 8, 2017Actual

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
Fujian Medical University Union Hospital	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

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome (MDS). At present, the necessity of chemotherapy pre-transplantation for RAEB-1, RAEB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT remains in discussion. In this study, the effects of chemotherapy and no chemotherapy pre-transplantation in patients with RAEB-1, REAB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT are evaluated.

Detailed Description

Allo-HSCT appears to be an efficient tool to cure patients with MDS and AML secondary to MDS. Decitabine and/or chemotherapy pre-transplantation could reduce the blast cells in bone marrow and improve the complete remission rate. However, decitabine and/or chemotherapy had side effects and might increase treatment-related mortality. At present, the necessity of chemotherapy pre-transplantation for RAEB-1, RAEB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT remains in discussion. In this study, the effects of chemotherapy and no chemotherapy pre-transplantation in patients with RAEB-1, REAB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT are evaluated.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Therapy pre-transplantation		Chemotherapy regimen and/or demethylation drugs(such as decitabine) were given pre-transplantation for patients with RAEB-1, REAB-2 and AML Secondary to MDS (bone marrow blast cells less than 50%).	Drug: Demethylation drug Drug: Chemotherapy regimen
No Therapy pre-transplantation		No therapy (chemotherapy or demethylation drugs) was given pre-transplantation for patients with RAEB-1, REAB-2 and AML Secondary to MDS (bone marrow blast cells less than 50%).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Demethylation drug	Drug	Demethylation drug,such as Decitabine	Therapy pre-transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival (OS)		2 year

Secondary Outcomes

Measure	Description	Time Frame
relapse rate		2 year
disease-free survival (DFS)		2 year
transplant-related mortality (TRM)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

RAEB-1, REAB-2 and AML Secondary to MDS (Bone marrow blast cells less than 50%) 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

RAEB-1, REAB-2 and AML Secondary to MDS (Bone marrow blast cells less than 50%) undergoing allo-HSCT

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qifa Liu	Contact	020-62787883		liuqifa628@163.com

Overall Officials

Name	Affiliation	Role
Qifa Liu	Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou, Guangdong, China, 510515	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36905177	Derived	Pan D, Zhao W, Jiang Q, Yin C, He H, Liao L, Ye J, Dai M. Wilms' tumor 1 expression combined with genetic mutations for prognostic assessment in MDS. Leuk Lymphoma. 2023 Apr;64(4):856-864. doi: 10.1080/10428194.2023.2185086. Epub 2023 Mar 11.

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases