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

NCT05456048 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 231

Last updated 2022-07-13

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

VAH regimen

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.

DRUG

VEN+HMA regimen

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.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER

  • Shenzhen Hospital of Southern Medical University

    collaborator OTHER

  • Peking University Shenzhen Hospital

    collaborator OTHER

  • Shenzhen Second People's Hospital

    collaborator OTHER

  • The Seventh Affiliated Hospital of Sun Yat-sen University

    collaborator OTHER

  • Southern Medical University, China

    collaborator OTHER

  • First People's Hospital of Chenzhou

    collaborator OTHER

  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Liu Qifa, MD · Nanfang Hospital, Southern Medical University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05456048 on ClinicalTrials.gov