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The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. This study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with Ph- ALL, aiming to improve the MRD-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric-inspired Regimen Combined With Venetoclax | Experimental | Induction therapy is administered as follows：Vincristine (VCR) 1.4 mg/m2 (maximum dose 2 mg) IV on D1,8,1,5,22; Daunorubicin (DNR) 30 mg/m2/day IV on D1-3; Cyclophosphamide (CTX) 1200 mg/m2 IV on D1,15; Pegaspargase 2500u/m2 IM on D5; Prednisone 1 mg/kg/d PO on D1-14, 0.5 mg/kg/d PO on D15-28; Venetoclax 100 mg PO on D6，200 mg on D7, 400mg on D8-14, All patients underwent bone marrow aspiration on day 14 during induction. Patients with bone marrow blasts ≥10% on day 14 of induction received 7 additional days of Venetoclax on day 15-22. Consolidation therapy is a combination of multi-drug pediatric-inspired regimen chemotherapy and Venetoclax. Maintenance therapy consisted of a monthly VMMP regimen (vincristine, mercaptopurine, methotrexate, prednisone) continuing until 3 years for male and 2.5 years for female patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vincristine | Drug | Anti-tumor alkaloids |
| |
| Measure | Description | Time Frame |
|---|---|---|
| MRD-negative complete remission rate measured by flow cytometry | After induction (4 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission (CR) rate | After 2 cycles of chemotherapy, an expected average of 3 months | |
| Overall survival (OS) | From the date of registration to the date of death resulting from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianxiang Wang, Dr | Contact | 86-22-23909120 | wangjx@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianxiang Wang, Dr | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | 300020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42166560 | Derived | Gong X, Liu Y, Fang Q, Gu R, Liu K, Lin D, Zhou C, Zhang G, Gong B, Wei S, Li Y, Li S, Wang Y, Qiu S, Liu B, Wang Y, Mi Y, Wei H, Wang J. Venetoclax Plus Pediatric Regimen in Adolescents and Adults with Ph-Negative Acute Lymphoblastic Leukemia. Blood. 2026 May 21:blood.2026033577. doi: 10.1182/blood.2026033577. Online ahead of print. |
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| Daunorubicin |
| Drug |
Anthracycline |
|
| Cyclophosphamide | Drug | Alkylating agent |
|
| Pegaspargase | Drug | Polyethylene glycol (PEG) conjugated to L-asparaginase |
|
| Prednisone | Drug | Glucocorticoids |
|
| Cytarabine | Drug | Pyrimidine antimetabolites |
|
| 6-mercaptopurine | Drug | Cell cycle-specific antitumor drug |
|
| Dexamethasone | Drug | Glucocorticoids |
|
| Methotrexate | Drug | Antifolate antineoplastic drug |
|
| Venetoclax | Drug | Selective inhibitor of B-cell lymphoma 2 (Bcl-2) |
|
| Up to 5 years post-registration |
| Relapse free survival (RFS) | From the date of complete remission(CR) until the date of documented relapse or death due to any cause or the last follow-up day | Up to 5 years post-registration |
| Disease-free Survival (DFS) | From CR1 to relapse, death from any cause or last follow-up | Up to 5 years post-registration |
| The rate of adverse events | An expected average of 24 months |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D014750 | Vincristine |
| D003630 | Daunorubicin |
| D003520 | Cyclophosphamide |
| C042705 | pegaspargase |
| D011241 | Prednisone |
| D003561 | Cytarabine |
| D015122 | Mercaptopurine |
| D003907 | Dexamethasone |
| D008727 | Methotrexate |
| C579720 | venetoclax |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 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 |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
| D011246 | Pregnadienetriols |
| D013259 | Steroids, Fluorinated |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
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