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This clinical trial included 30 cases and aimed to understand the effectiveness and safety of the VMAC regimen combined with donor lymphocyte infusion (DLI) in the treatment of patients with acute myeloid leukemia who have relapsed after allogeneic hematopoietic stem cell transplantation.
The main questions it aims to answer are:
The safety and efficacy of VMAC combined with DLI in the treatment of allo HSCT recurrence in AML patients;
venetoclax 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; liposomal mitoxantrone 30 mg/m2/d, d1; cytarabine (Ara-C) 100 mg/m2/d, d1-7; cyclophosphamide (CY) 400 mg/m2/d, d2, 5),and then rest for 1 day before giving cryopreserved donor stem cells.MNC1-2X10^8/kg infusion, low-dose (25 mg Bid), short-course treatment (2-3 weeks after DLI) oral cyclosporine (CSA) is added to prevent graft-versus-host disease starting 3 days before the infusion of cryopreserved stem cells.
Monitor the occurrence of serious infections, cardiac toxicity, GVHD and other adverse reactions during the medication process; Blood routine recovery or bone marrow re examination 4 weeks after DLI to evaluate the efficacy of one course of VMAC combined with DLI; The patient was followed up for 2 years to evaluate long-term efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VMAC+DLI | Experimental | VMAC regimen : Veneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoxantrone hydrochloride liposome | Drug | Veneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| CRR | All tumor target lesions disappear, no new lesions appear, and tumor markers are normal, maintained for at least 4 weeks | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| PR | The maximum sum of diameters of tumor lesions decrease≥ 30% and is maintained for at least 4 weeks | 1 year |
| ORR | CR+PR | 1year |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who meet any of the following criteria shall not be enrolled in this study:
1) Secondary transplant patients;
2) Have a history of tumor and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer , basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN) or prostate intraepithelial carcinoma (PIN);
3) Serological reactions of known HIV, active hepatitis B, and active hepatitis C virus positive or syphilis positive;
4) Suffering from mental illness or other conditions and unable to cooperate with the requirements of research treatment and monitoring;
5) Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment;
6) Active heart disease, definition One or more of the following:
7) Transplantation from an unrelated donor;
8) Those deemed not suitable for enrollment by the researcher.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Chen, Doctor | Contact | 13920985705 | chenxin@ihcams.ac.cn | |
| Xueou Liu, Doctor | Contact | 022-23909095 | ec@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xin Chen, Doctor | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, China | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| D003561 | Cytarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
|
| 2-year OS | The time from the start of treatment to death due to any reason | 2 years |
| DFS | The time from the start of treatment to disease recurrence or death from any cause | 2 years |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |