Low-dose AZA Combined With Short Term CAG Derived Regimen... | NCT04216355

Studies
Low-dose AZA Combined With Short Term CAG Derived Regimen as a Bridging Treatment in Patients With Advanced MDS Prior to Allo-HSCT

NCT04216355

Sponsor

Fujian Medical University

Status

Unknown status

Last Update Posted

Jan 3, 2020Actual

Enrollment

20Estimated

Phase

Phase 2Phase 3

Conditions

MDS-EB

Interventions

Azacitidine
CAG Protocol

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

Jan 2020

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

Jan 2020Estimated

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Dec 30, 2019

First Submission Date that Met QC Criteria

Dec 30, 2019

First Posted Date

Jan 2, 2020Actual

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

Jan 1, 2020

Last Update Posted Date

Jan 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This single arm, prospective study on the feasibility of a bridging treatment with low-dose azacitidine (AZA) in combination with short term CAG derived regimen prior to allogeneic stem cell transplantation (allo-HSCT) in patients with advanced myelodysplastic syndromes (MDS) .

Detailed Description

Not provided

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AZA with CAG derived regimen	Experimental	Azacitidine 50mg/m²/day, D1-D5 (IV) Aclarubicin 5mg/m²/day, D1-D4 (IV) Cytarabine 10mg/m²/12h, D1-D6 (IV) G-CSF 5-10ug/kg/day, D1-D7 (SC)	Drug: Azacitidine Drug: CAG Protocol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azacitidine	Drug	Low-dose AZA	AZA with CAG derived regimen
CAG Protocol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Time to Engraftment		Baseline to engraftment, assessed minimally 28 days post transplant

Secondary Outcomes

Measure	Description	Time Frame
Cumulative Incidence of Graft-versus Host Disease		Up to 2 years
Incidence of systemic infections		Up to 2 years
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

New Diagnosed advanced myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant is planned
Recipient of an allogeneic hematopoietic stem cell transplantation
Age < 65 years
ECOG performance status ≤2
Written informed consent
No psychological, familial, social, or geographic reason that would compromise clinical follow up

Exclusion Criteria:

Relapsed or refractory advanced MDS
Severe pshyciatric or organic disorder, supposed to be independent from advanced MDS, that would contraindicate treatment
Known allergic or hypersensitivity to azacitidine, aclarubicin or cytarabine or to any of the test compounds, materials
Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

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
Ting Yang, Prof.M.D.Ph.D	Contact	86-591-86218441		yang.hopeting@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Medical University Union Hospital	Recruiting	Fuzhou	Fujian	350001	China

Intervention Browse Module

MeSH Terms

ID	Term
D001374	Azacitidine
C411062	CAG protocol

Ancestor Terms

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

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Browse Branches

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