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Starting soon Not applicable

Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Re-treatment for Patients With High-Risk Acute Myeloid Leukemia

NCT06643195 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-01-01
Last updated
2024-12-30

Condition(s) studied

AML

Investigational drug(s) / intervention(s)

ImmediateAllogeneic Hematopoietic Stem Cell TransplantationRetreatment

ImmediateAllogeneic Hematopoietic Stem Cell Transplantation: patients proceeded to allogeneic HSCT as soon as possible. Patients were allowed to receive low-dose chemotherapy that is not intended for the purpose of achieving a second remission.

Retreatment: Receive a second course of anti-leukemic treatment prior to allogeneic HSCT. The anti-leukemic treatment regimen will be determined based on the genetic mutation status. Patients without targetable mutations will receive a combination of BCL-2 inhibitors and demethylating agents as salvage chemotherapy. Patients with targetable mutations will receive appropriate targeted therapy (e.g., FLT3 inhibitors, IDH inhibitors).

Study summary

This study aims to investigate whether immediate HSCT for patients with high-risk AML and intermediate-risk AML who have not achieved complete remission (CR) after their first induction therapy is non-inferior to re-treatment with chemotherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. AML patients aged ≥ 18 years. 2. High-risk AML patients according to the 2022 ELN standards who received one cycle of induction therapy. 3. Requires allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic HSCT and unrelated donor transplant). 4. KPS score greater than 60. 5. Informed consent must be signed before the start of the study procedures; if it is detrimental to the patient's condition for them to sign, the consent may be signed by a legal guardian or immediate family member. Exclusion Criteria: 1. Acute promyelocytic leukemia. 2. Patient has received more than 440 mg/m2 daunorubicin equivalents. The cumulative dose is calculated by summing up isotoxic daunorubicin-equivalents for daunorubicin, doxorubicin, epirubicin, idarubicin and mitoxantrone. The conversion factors are derived from the comparison of the respective maximum doses. The conversion factor is 1 for daunorubicin, 1 for doxorubicin, 0.6 for epirubicin, 4.6 for idarubicin, and 2.7 for mitoxantrone (see worksheet for calculation). 3. Severe organ dysfunction, defined as: 1\) Left ventricular ejection fraction \<50%. 2) Patients who receive supplementary continuous oxygen. 3) Serum bilirubin \>1.5 x ULN (if not considered Gilbert-Syndrome) or ASAT/ALAT \>5 x ULN. 4\) Estimated Glomerular Filtration Rate (GFR) \< 50 ml/min, where: Estimated GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black) 4. History of allogeneic transplantation. 5. Manifestation of AML in the Central Nervous System. 6. Pregnant or breastfeeding women.

Primary outcome measure(s)

  • treatment success — day 56 after allogeneic HCT
    The primary endpoint, treatment success defined as complete remission on day 56 after allogeneic HCT, was defined as dichotomous success rate.

Trial sites (4)

FacilityCityRegionStatus
Hebei Medical University Second Hospital Shijiazhuang Hebeisheng
Zhengzhou University First Affiliated Hospital Zhengzhou Henan
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army Jinan Shandong
People's Liberation Army The General Hospital of Western Theater Command Chengdu Sichuan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06643195 on ClinicalTrials.gov ↗ ← All trials in China