Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06394011
Other study ID # VA+HAAG
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 15, 2024
Est. completion date December 30, 2026

Study information

Verified date January 2024
Source The First Affiliated Hospital of Soochow University
Contact Xiaowen Tang, Ph.D
Phone (0086)51267780086
Email xwtang1020@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.


Description:

This is a single-center, single-arm, prospective clinical study in newly diagnosed intermediate and high-risk AML patients. The patients will receive venetoclax, azacitidine combined with HAAG regimen in the induction treatment.


Read more »

Study Design


Intervention

Drug:
venetoclax, azacitidine and HAAG regimen
Venetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3~10, per os; Azacitidine:75mg/m2/d, d1~7, subcutaneous injection; Homoharringtonine:1mg/d, d4~10, intravenous infusion; Aclarubicin:10mg/d, d4~7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4~10, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300µg/d (when WBC counts are less than 20×10^9/L ),subcutaneous injection;

Locations

Country Name City State
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite complete response rate (CRc; CR+CRi) CRc includes complete response CR and CRi; CR was defined as < 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as<5% bone marrow blasts, either ANC<1×10^9/L or platelets<100×10^9/L, transfusion independence but with persistence of cytopenia. Day 28-35 of induction course
Secondary Partial remission (PR) PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts. Day 28-35 of induction course
Secondary Number of adverse events adverse events are evaluated with CTCAE V5.0. 2 years
Secondary Relapse-free survival (RFS) time from clinical CRc (CR and CRi) to the first relapse or death 3 years
Secondary Overall survival (OS) time from the first day of treatment to death or lost to follow-up for any cause. 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT05066958 - Ex-vivo Primed Memory Donor Lymphocyte Infusion to Boost Anti-viral Immunity After T-cell Depleted HSCT Phase 1/Phase 2
Recruiting NCT05237258 - Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia N/A
Completed NCT01696084 - Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia Phase 3
Active, not recruiting NCT02861417 - Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant Phase 2
Recruiting NCT03384225 - CBA Versus FBA Conditioning Followed by Haploidentical Allogeneic HSCT in Treatment of High Risk and Refractory AML Phase 3
Recruiting NCT03384212 - CBA Versus FBA Conditioning Followed by Allogeneic HSCT in Treatment of High Risk and Refractory AML Phase 3