ImmediateAllogeneic Hematopoietic Stem Cell Transplantation
Otherpatients 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.
NCT Number: NCT06643195
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Hebei Medical University Second Hospital, Shijiazhuang, Hebeisheng, China
For patients who have already received targeted therapy during induction treatment, the researchers may choose the treatment regimen based on the individual patient's condition.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
Time frame: 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.
Time frame: HSCT rates at 4,8,16, and 24 weeks
Time frame: Date of first documented CR or CRi or CRchim Death before CR/CRi/CRchim not achieve a CR or CRi by six months
b) Starting point: day 56 c) Events: Relapse (both, hematologic or molecular) and death
Time frame: Death
Time frame: death before relapse, relapse (both, hematological or molecular), and failure to achieve a CR at final remission assessment
Time frame: day 56
efined only for per-protocol treated patients who met the primary endpoint b) Starting point: day 56 c) Events: Relapse (both, hematologic or molecular) and death
Time frame: day 56
Time frame: Death
Contact information is provided by the study sponsor or research team.
Institute of Hematology & Blood Diseases Hospital, China
Other
Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Re-treatment for Patients With High-Risk Acute Myeloid Leukemia: a Randomised, Open-label, Phase 2 Clinical Trial.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07695571
AML, Bone Marrow Transplantation
View Trial DetailsNCT07539818
AML
View Trial DetailsNCT07516353
ALL, AML
Boston, Massachusetts, United States
View Trial DetailsNCT07342244
AML, AML (Acute Myeloid Leukemia)
Wuhan, Hubei, China
View Trial Details