NCT05456048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

3.5 years

First QC Date

July 3, 2022

Last Update Submit

July 8, 2022

Conditions

Relapsed Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaGene AbnormalityCytogenetic Abnormality

Keywords

Acute myeloid leukemiaRelapsed/refractoryGene mutationVenetoclaxHomoharringtonine

Outcome Measures

Primary Outcomes (1)

  • CR/CRi

    Complete remission and CR with incomplete count recovery

    At the end of Cycle 2 (each cycle is 28 days)

Secondary Outcomes (4)

  • MRD negative

    At the end of Cycle 2 (each cycle is 28 days)

  • Overall response

    At the end of Cycle 2 (each cycle is 28 days)

  • Overall survival

    2 years

  • Event-free survival

    2 years

Study Arms (2)

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

VAH regimenDRUG

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.

VAH group
VEN+HMA regimenDRUG

VEN was prescribed as 100mg day 1, 200mg day 2, 400mg day 3-28; AZA was used at the dose of 75 mg/m2, day 1-7 or DEC 20mg/m2 day 1-5. The dose of VEN was reduced to 100mg/d if co-administered with posaconazole or voriconazole.

VEN+HMA group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow and/or peripheral blood were taken from participants upon enrollment for diagnosis and detection of gene mutations and co-mutations via PCR, direct sequencing and /or next generation sequencing.

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteChromosome AberrationsRecurrence

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Liu Qifa, MD

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2022

First Posted

July 13, 2022

Study Start

December 3, 2018

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07

Locations

CN(1)