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

NCT06643195 | Not Yet Recruiting

• 1 other identifier: IIT2024063
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

AML

Keywords

High-Risk Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• treatment success

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

  day 56 after allogeneic HCT

Secondary Outcomes (7)

• Cumulative Incidences of Allogeneic HSCT

  HSCT rates at 4,8,16, and 24 weeks

• Incidence of Complete Remission from Randomisation

  Date of first documented CR or CRi or CRchim Death before CR/CRi/CRchim not achieve a CR or CRi by six months

• Overall survival after HCT

  Death

• Event-free survival after HCT

  death before relapse, relapse (both, hematological or molecular), and failure to achieve a CR at final remission assessment

• Leukemia-free survival from day 56 after alloHCT for patients who met the primary endpoint

  day 56

Study Arms (2)

Disease control group

EXPERIMENTAL

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.

Other: ImmediateAllogeneic Hematopoietic Stem Cell Transplantation

Retreatment group

ACTIVE COMPARATOR

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).

Other: Retreatment

Interventions

ImmediateAllogeneic Hematopoietic Stem Cell Transplantation OTHER

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.

Disease control group

Retreatment OTHER

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).

Retreatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AML patients aged ≥ 18 years.
• High-risk AML patients according to the 2022 ELN standards who received one cycle of induction therapy.
• Requires allogeneic hematopoietic stem cell transplantation (including HLA-matched or mismatched allogeneic HSCT and unrelated donor transplant).
• KPS score greater than 60.
• 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.

You may not qualify if:

• Acute promyelocytic leukemia.
• 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).
• Severe organ dysfunction, defined as:
• \) 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.
• \) 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (4)

Hebei Medical University Second Hospital

Shijiazhuang, Hebeisheng, 050000, China

Location

Zhengzhou University First Affiliated Hospital

Zhengzhou, Henan, 450000, China

Location

The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army

Jinan, Shandong, China

Location

People's Liberation Army The General Hospital of Western Theater Command

Chengdu, Sichuan, 610083, China

Location

MeSH Terms

Interventions

Retreatment

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

erlie jiang

CONTACT

15122538106; jiangerlie@ihcams.ac.cn

yigeng cao

CONTACT

18622477066; caoyigeng@ams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: October 16, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

CN (4)