Prophylactic HQP1351 Therapy Post-transplants on Leukemia... | NCT05604755

Studies
Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT

NCT05604755

Sponsor

xuna

Status

Withdrawn

Last Update Posted

Jan 18, 2023Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Prophylactic HQP1351 Therapy
Third Generation TKI

Interventions

HQP1351( Olverembatinib dimesylate)

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 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Drugs was too expensive eligible for inclusion

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 30, 2023Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Oct 30, 2022

First Submission Date that Met QC Criteria

Oct 30, 2022

First Posted Date

Nov 3, 2022Actual

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 16, 2023

Last Update Posted Date

Jan 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

xuna, professor, Nanfang Hospital, Southern Medical UniversitySponsor-Investigator

Lead Sponsor

xunaOTHER

Collaborators

Name	Class
Nanfang Hospital, Southern Medical University	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)

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

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and BC-CML. Relapse remains a major cause of treatment failure even after allo-HSCT. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Pre-emptive tyrosine kinase inhibitor (TKIs) administration based on minimal residual disease (MRD) and BCR-ABL mutation after allo-HSCT might reduce the incidence of relapses and improve survival for patients with Ph+ luekemia. In this study, we will evaluate the safety and efficacy of newly third TKI-HQP1351 therapy post-transplants on Ph+ leukemia after allo-HSCT with MRD positive pre-transplants.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HQP1351 prophylactic therapy	Experimental	HQP1351 prophylactic therapy after allo-hct on days 30 to 60	Drug: HQP1351( Olverembatinib dimesylate)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HQP1351( Olverembatinib dimesylate)	Drug	HQP1351 was initiated at a dose of 40mg every two days	HQP1351 prophylactic therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease Free Survival（DFS）	The time from the date of transplantation to leukemia relapse	2 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival(OS)	the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up The time from the date of transplantation to death or the last day of follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient age of 18-65 years
Ph+ luekemia(includ Ph+ALL and CML) undergoing allo-HSCT with MRD positive pre-transplants
Survival > 30 days post-transplants
Laboratory parameters as defined below:

Serum creatinine less than or equal to 2.0 x ULN AST and ALT less than or equal to 3 x ULN (less than or equal to 5 x ULN if unequivocal liver GvHD),Total bilirubin less than or equal to 3 x ULN
Ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

Ph+ ALL undergoing allo-HSCT with MRD negative pre-transplants
Survival <30 days post-transplants
MRD positive on day +30 post-transplants
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

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided