Influence of Molecular Abnormalities on Response of VAH v... | NCT05456048

Studies
Influence of Molecular Abnormalities on Response of VAH vs. VEN+HMA in RR-AML

NCT05456048

Sponsor

Nanfang Hospital, Southern Medical University

Status

Completed

Last Update Posted

Jul 13, 2022Actual

Enrollment

231Actual

Phase

Not provided

Conditions

Relapsed Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Gene Abnormality
Cytogenetic Abnormality

Interventions

VAH regimen
VEN+HMA 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 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 3, 2018Actual

Primary Completion Date

May 31, 2022Actual

Completion Date

May 31, 2022Actual

First Submitted Date

Jul 3, 2022

First Submission Date that Met QC Criteria

Jul 8, 2022

First Posted Date

Jul 13, 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

Jul 8, 2022

Last Update Posted Date

Jul 13, 2022Actual

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
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	OTHER
Zhongshan People's Hospital, Guangdong, China	OTHER
Shenzhen Hospital of Southern Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of this study is to reveal the influence of gene mutations on the treatment response of the regimen of HHT combined with Venetoclax plus AZA versus venetoclax plus HMA in the salvage therapy of RR-AML.

Detailed Description

Venetoclax-based regimens have heen used in the salvage therapy of relapsed/resfractory (RR) acute myeloid leukemia (AML). More and more studies have shown that molecular abnormalities and venetoclax combined regimens significantly impact the response of venetoclax-based therapy. Our exploratory study revealed that venetoclax plus azacytidine combined with homoharringtonine (VAH) had remarkably higher response than venetoclax plus hypomethylating agents (HMA) in RR-AML. Yet the influence of molecular abnormalities on the response of VAH regimen remains unknown.

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

Retention

Enrollment

231Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VAH group		Patients assigned to this group received one to two cycles of VAH regimen as salvage therapy of RR-AML.	Drug: VAH regimen
VEN+HMA group		Patients assigned to this group received one to two cycles of venetoclax plus HMA regimen as salvage therapy of RR-AML.	Drug: VEN+HMA regimen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VAH regimen	Drug	VEN was prescribed as 100mg day 1, 200mg day 2, 400mg day 3-14; AZA was used at the dose of 75 mg/m2, day 1-7; HHT was given at a dose of 1mg/m2, day 1-7. The dose of VEN was reduced to 100mg/d if co-administered with posaconazole or voriconazole.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CR/CRi	Complete remission and CR with incomplete count recovery	At the end of Cycle 2 (each cycle is 28 days)

Secondary Outcomes

Measure	Description	Time Frame
MRD negative	MRD was detected with FCM and defined negative as a ratio < 0.1%	At the end of Cycle 2 (each cycle is 28 days)
Overall response	Overall response included CR/CRi, MLFS and PR.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

RR-AML
Patients must have been treated for at least one cycle of VEN-based regimen and finished outcome assessment.

Exclusion Criteria:

Acute promyelocytic leukemia (AML subtype M3)
Previous exposure to the treatment of VEN-based regimen
Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
Respiratory failure (PaO2 ≤60mmHg)
Hepatic abnormalities (total bilirubin ≥2 times the upper limit of normal [ULN], alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the ULN)
Renal dysfunction (creatinine ≥2 times the ULN or creatinine clearance rate < 30 mL/min)
ECOG performance status 3, 4 or 5
Substantial history of neurological, psychiatric, endocrine, metabolic, immunological, or any other medical condition not suitable for the trial (investigators' decision)
Active acute or chronic graft-versus-host disease (GVHD). Active acute GVHD or chronic GVHD is defined as GVHD requiring either at least 1 mg/kg per day of prednisone (or equivalent) or treatment beyond systemic corticosteroids.
Patients with pregnancy
Uncontrolled active infection
Clinically significant coagulation abnormalities

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

Cases included in this study were from 3 previous studies of our study group, including 1 exploratory and 2 prospective studies.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute
D002869	Chromosome Aberrations
D012008	Recurrence

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided