Floatz Rating
B60/100
Confidence
Indicative
Sponsor
Princess Maxima Center for Pediatric Oncology
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
58High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07175415CT.gov HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies | — | Not Yet Recruiting | — | — | — |
NCT07454226CT.gov ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL | — | Recruiting | — | — | — |
NCT05745714CT.gov HEM-iSMART-C: Ruxolitinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies | — | Recruiting | — | — | — |
NCT05751044CT.gov HEM-iSMART-B: Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies | — | Recruiting | — | — | — |
NCT06855810CT.gov Newly-diagnosed Pediatric T-cell ALL Protocol | — | Recruiting | — | — | — |
NCT06764238CT.gov Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol | — | Recruiting | — | — | — |
NCT06481241CT.gov Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL | — | Recruiting | — | — | — |
NCT06078306CT.gov CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL). | — | Unknown | — | — | — |
NCT06087419CT.gov A Prospective Clinical Study of Bridging alloHSCT After Treatment With Obinutuzumab in Combination With Chidamide and Venetoclax in RR Ph-ALL and B-cell Lymphoma Patients | — | Unknown | — | — | — |
NCT05740449CT.gov HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies | — | Withdrawn | — | — | — |
Show 22 more trialsShow fewer
NCT05464836CT.gov Phase II Study to Evaluate Safety and Efficacy of CB-103 With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-ALL or T-LBL | — | Terminated | — | — | — |
NCT05292664CT.gov Venetoclax Basket Trial for High Risk Hematologic Malignancies | — | Recruiting | — | — | — |
NCT05657652CT.gov CAV Regimen for R/R Ph- B-ALL | — | Recruiting | — | — | — |
NCT05192889CT.gov Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax | — | Active Not Recruiting | — | — | — |
NCT05386576CT.gov A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) | — | Active Not Recruiting | — | — | — |
NCT05005299CT.gov Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation | — | Unknown | — | — | — |
NCT05268003CT.gov A Phase II Study of the Combination of Ponatinib With Mini-hyper CVD Chemotherapy and Venetoclax in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia | — | Terminated | — | — | — |
NCT05433532CT.gov Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients | — | Completed | — | — | — |
NCT04988555CT.gov A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1) | — | Recruiting | — | — | — |
NCT05182385CT.gov Venetoclax in Addition to Blinatumomab in Adult Patients With Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) | — | Active Not Recruiting | — | — | — |
NCT05054465CT.gov A Phase 1b-2 Trial to Assess Venetoclax and Navitoclax Consolidation and Post-transplant Maintenance in High-risk Patients With T-ALL | — | Not Yet Recruiting | — | — | — |
NCT05016947CT.gov Venetoclax Plus Inotuzumab for B-ALL | — | Active Not Recruiting | — | — | — |
NCT04752163CT.gov DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia | — | Terminated | — | — | — |
NCT03878524CT.gov Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | — | Terminated | — | — | — |
NCT04029688CT.gov A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors | — | Terminated | — | — | — |
NCT03844048CT.gov An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial | — | Active Not Recruiting | — | — | — |
NCT03576547CT.gov Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia | — | Terminated | — | — | — |
NCT03181126CT.gov A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma | — | Completed | — | — | — |
NCT03236857CT.gov A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies | — | Completed | — | — | — |
NCT02392572CT.gov ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome | — | Recruiting | — | — | — |
NCT03592576CT.gov Expanded Access to Navitoclax | — | No Longer Available | — | — | — |
NCT03123029CT.gov Expanded Access to Venetoclax | — | Available | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Acute Lymphoblastic Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Venetoclax (this asset) | Princess Maxima Center for Pediatric Oncology | P3 | B · 60 |
| Gm-Csf | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | P4 | BBB |
| Peripheral Blood Stem Cells, Allogeneic, Cd34 Positive | Fred Hutchinson Cancer Center | P2/3 | BBB |
| Thioguanine Anhydrous | St. Jude Children's Research Hospital | P4 | BBB |
| Equine Atg | Instituto Nacional de Cancer, Brazil | P3 | BBB |
| Methotrexate | Princess Maxima Center for Pediatric Oncology | P4 | BB |
| Pegaspargase | Dana-Farber Cancer Institute | P4 | BB |
| Cyclophosphamide | Sawa Ito, MD | P4 | BB |
| Mercaptopurine Anhydrous | Dana-Farber Cancer Institute | P4 | BB |
+42 more in the Acute Lymphoblastic Leukemia cohort
Other indications for Venetoclax
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | — | P4 | BB · 70 |
| Acute Myeloid Leukemia | — | P4 | BB · 69 |
| Chronic Myelomonocytic Leukemia | — | P2/3 | BB · 68 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
- Gm-CsfXinhua Hospital, Shanghai Jiao Tong University School of MedicineBBB
- Peripheral Blood Stem Cells, Allogeneic, Cd34 PositiveFred Hutchinson Cancer CenterBBB
- Thioguanine AnhydrousSt. Jude Children's Research HospitalBBB
- Equine AtgInstituto Nacional de Cancer, BrazilBBB
- MethotrexatePrincess Maxima Center for Pediatric OncologyBB
Citation
Floatz Terminal. Venetoclax in Acute Lymphoblastic Leukemia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/venetoclax-acute-lymphoblastic-leukemia
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