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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidences of Allogeneic HSCT |
| HSCT rates at 4,8,16, and 24 weeks |
| Incidence of Complete Remission from Randomisation |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| erlie jiang | Contact | 15122538106 | jiangerlie@ihcams.ac.cn | |
| yigeng cao | Contact | 18622477066 | caoyigeng@ams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Medical University Second Hospital | Shijiazhuang | Hebeisheng | 050000 | China |
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| 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). |
|
b) Starting point: day 56 c) Events: Relapse (both, hematologic or molecular) and death
| 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 | 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 | day 56 |
| Rate of MRD Negative from Day 56 after HSCT |
| day 56 |
| 7. Overall Survival from Randomization: Measured from the start of randomization, with the primary event being death. |
| Death |
| Zhengzhou University First Affiliated Hospital | Zhengzhou | Henan | 450000 | China |
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| The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army | Jinan | Shandong | China |
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| People's Liberation Army The General Hospital of Western Theater Command | Chengdu | Sichuan | 610083 | China |
| ID | Term |
|---|---|
| D019233 | Retreatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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