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ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VHAG group | Experimental | Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28. HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14(d10-d14) G-CSF: 100ug/m2 daily on d1-14 if WBC count <10*10E9/L |
|
| Traditional Chemotherapy Regimen group | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Homoharringtonine | Drug | Intravenous infusion |
| |
| venetoclax |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year EFS | 1-year event free survival rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| CR/CRi | Complete remission/complete remission with incomplete count recovery | At the end of Cycle 1 (up to 42 days) |
| OS | Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| Drug |
Orally by mouth |
|
| Cytarabine | Drug | subcutaneous injection or Intravenous infusion |
|
| G-CSF | Drug | subcutaneous injection |
|
| Vindesine | Drug | Intravenous infusion |
|
| Daunorubicin | Drug | Intravenous infusion |
|
| cyclophosphamide | Drug | Intravenous infusion |
|
| Dexamethasone | Drug | Intravenous infusion or orally |
|
| L-ASP | Drug | subcutaneous injection |
|
| through study completion, up to 3 years |
| MRD | Percentage of participants who converted to MRD < 10^-3 after the first cycle of treatment. | At the end of Cycle 1 (up to 42 days) |
| Safety of induction therapy | Adverse events | At the end of Cycle 1 (up to 42 days) |
| ID | Term |
|---|---|
| D000077863 | Homoharringtonine |
| C579720 | venetoclax |
| D003561 | Cytarabine |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D014751 | Vindesine |
| D003630 | Daunorubicin |
| D003520 | Cyclophosphamide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D006248 | Harringtonines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
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