Combining venetoclax and azacitidine with HAAG for treating newly diagnosed AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of a treatment regimen combining venetoclax and azacitidine with HAAG in patients newly diagnosed with intermediate and high-risk acute myeloid leukemia (AML). It is a single-center, single-arm, prospective study that aims to provide an effective induction treatment for these patients. Participants will receive the combined therapy and will be monitored for treatment outcomes and safety profiles.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
2. Age 18-65.
3. ECOG score: 0-2.
4. No history of previous chemotherapy or target therapy.
5. Serum total bilirubin \<= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) \<= 1.5 times ULN, aspartate aminotransferase (AST) \<=1.5 times ULN;
6. Creatinine clearance rate \>=30 mL/min;
7. Serum lipase \<= 1.5 times ULN, amylase \<= 1.5 times ULN;
8. Capable to understand and willing to participate in this study, signed the informed consent form.

Exclusion Criteria:

1. AML transformed with chronic myelogenous leukemia.
2. Acute promyelocytic leukemia (type M3).
3. Patients with a second malignancy requiring treatment.
4. Patients with uncontrolled active infection.
5. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
6. Patients with hepatic and renal inadequacy: total serum bilirubin \>=2.0 mg/dl, AST \>=3 times ULN, serum creatinine clearance (Ccr) \<50 ml / min.
7. Patients with arterial oxygen saturation (SpO 2) was \<95%.
8. Patients with HIV infection.
9. Patients with active hepatitis B or hepatitis C infection.
10. Patients with other commodities that the investigators considered not suitable for the enrollment.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Xiaowen Tang, Ph.D
• Email: xwtang1020@163.com
• Phone: (0086)51267780086

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Venetoclax and Azacitidine Consolidation After Remission in Intermediate-Risk AML

  We’re testing if a venetoclax-plus-azacitidine consolidation approach works as well as standard high-dose chemotherapy for adults with intermediate-risk AML who have already achieved remission and are headed to stem cell transplant.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07672262

• Gilteritinib with Venetoclax and Azacitidine, then High‑Dose Cytarabine and Gilteritinib Maintenance for Newly Diagnosed FLT3‑ITD AML

  This approach tests whether combining gilteritinib with venetoclax and azacitidine for induction, followed by DeepScan‑guided high‑dose cytarabine consolidation and gilteritinib maintenance, can produce deep remissions and allow fit adults with newly diagnosed FLT3‑ITD AML to avoid transplant.

  Recruiting Phase 2 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07259707

• Donor γδ T cell infusion to prevent relapse after stem cell transplant in high‑risk AML

  This will test whether a donor γδ T cell infusion given soon after an allogeneic stem cell transplant can help prevent relapse in adults (18–65) with high‑risk acute myeloid leukemia.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07237230

• Venetoclax-enhanced BUCY versus standard BUCY conditioning for high‑risk AML and MDS before allogeneic stem cell transplant

  This will test whether adding venetoclax to BUCY conditioning before allogeneic stem cell transplant helps patients aged 12–60 with high‑risk AML or MDS stay in remission longer.

  Recruiting First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07183878

• Using CD45RA Depleted Stem Cells to Prevent Infections After Transplant

  This study is testing whether using special stem cells can help patients with high-risk leukemia recover their immune system faster and prevent infections after a stem cell transplant.

  Recruiting Phase 1/2 Children's Hospital of Philadelphia · Philadelphia, Pennsylvania · NCT06839456

• Digital application for improving quality of life in acute leukemia patients

  This study is testing a digital app designed to help newly diagnosed acute myeloid leukemia patients improve their quality of life and cope better during their chemotherapy treatment.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts and 2 other locations · NCT06472128

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.