Therapy Detail
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| Therapy Name | Venetoclax |
| Synonyms | |
| Therapy Description |
Venclexta (venetoclax) is a BH3-mimetic that binds to and inhibits BCL2, resulting in increased tumor cell apoptosis (PMID: 26589495, PMID: 25048785). Venclexta (venetoclax) is FDA approved for use in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with chemotherapy in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Venetoclax | Venclexta | ABT-199|RG7601|GDC-0199|ABT119|Venclyxto | BCL2 inhibitor 27 | Venclexta (venetoclax) is a BH3-mimetic that binds to and inhibits BCL2, resulting in increased tumor cell apoptosis (PMID: 26589495, PMID: 25048785). Venclexta (venetoclax) is FDA approved for use in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with chemotherapy in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| TP53 mutant | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Venetoclax | Guideline | Actionable | Venclexta (venetoclax) is indicated in the guidelines as second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org). | detail... |
| TP53 mutant | chronic lymphocytic leukemia | sensitive | Venetoclax | Guideline | Actionable | Venclexta (venetoclax) is included in guidelines as first-line therapy for patients with advanced chronic lymphocytic leukemia harboring TP53 mutations and for patients with relapsed or refractory disease (PMID: 38969011; ESMO.org). | detail... 38969011 |
| IDH2 D76fs | acute myeloid leukemia | sensitive | Venetoclax | Case Reports/Case Series | Actionable | In a Phase II trial, an acute myeloid leukemia patient harboring IDH2 D76fs demonstrated sensitivity to treatment with Venclexta (venetoclax), achieving a complete response with incomplete blood count recovery after 24 weeks (PMID: 27520294). | 27520294 |
| IDH1 mutant | acute myeloid leukemia | predicted - sensitive | Venetoclax | Phase II | Actionable | In a Phase II trial, 33% (4/12) of acute myeloid leukemia patients harboring either IDH1 or IDH2 mutations responded to treatment with Venclexta (venetoclax), demonstrating a complete response or complete response with incomplete blood count recovery (PMID: 27520294). | 27520294 |
| IDH2 mutant | acute myeloid leukemia | predicted - sensitive | Venetoclax | Phase II | Actionable | In a Phase II trial, 33% (4/12) of acute myeloid leukemia patients harboring either IDH1 or IDH2 mutations responded to treatment with Venclexta (venetoclax), demonstrating a complete response or complete response with incomplete blood count recovery (PMID: 27520294). | 27520294 |
| TP53 loss | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Venetoclax | Guideline | Actionable | Venclexta (venetoclax) is indicated in the guidelines as second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04229979 | Phase III | Galinpepimut-S Cytarabine Decitabine Venetoclax Azacitidine | Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (REGAL) | Active, not recruiting | USA | POL | HUN | GRC | FRA | ESP | DEU | 3 |
| NCT02966756 | Phase II | Venetoclax | A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Recruiting | NZL | AUS | 2 |
| NCT04171791 | Phase I | Venetoclax | A Study of ABT-199 (Venetoclax) for Cutaneous T Cell Lymphoma (CTCL) | Completed | USA | 0 |
| NCT05268003 | Phase II | Ponatinib Venetoclax | 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 | Active, not recruiting | USA | 0 |
| NCT02966782 | Phase I | Azacitidine + Venetoclax Venetoclax | A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) After Hypomethylating Agent-Failure | Completed | USA | DEU | AUS | 0 |
| NCT03485547 | Phase I | Venetoclax | Study of Venetoclax, a BCL2 Antagonist, for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) | Active, not recruiting | USA | 0 |
| NCT03766763 | Phase II | Venetoclax | Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A | Active, not recruiting | FRA | 0 |
| NCT03455504 | Phase II | Venetoclax | Venetoclax Add in Combination With Fludarabine, Cyratabine and Idarubicine in Induction for Acute Myelid Leukemia (V-FIRST) | Active, not recruiting | ITA | 0 |
| NCT03844048 | Phase III | Venetoclax | An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial | Active, not recruiting | USA | TUR | SWE | POL | NZL | IRL | GRC | GBR | FRA | ESP | DNK | CAN | BEL | AUT | AUS | 8 |
| NCT03422393 | Phase I | Ibrutinib + Venetoclax Venetoclax | Venetoclax With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib | Active, not recruiting | USA | 0 |
| NCT03878524 | Phase I | Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab | A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) | Terminated | USA | 0 |
| NCT06651970 | FDA approved | Obinutuzumab Zanubrutinib Rituximab Acalabrutinib Venetoclax | Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure | Not yet recruiting | USA | POL | ITA | GBR | ESP | CZE | 0 |
| NCT05725200 | Phase II | Dasatinib Palbociclib Gemcitabine Trastuzumab Cetuximab Pertuzumab Panobinostat Alectinib Venetoclax Larotrectinib Encorafenib Everolimus Idelalisib Crizotinib Pembrolizumab Methotrexate Talazoparib | Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer (EVIDENT) | Recruiting | NOR | 0 |
| NCT02756611 | Phase III | Venetoclax | A Study to Evaluate the Efficacy of Venetoclax in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) Including Those With 17p Deletion or TP53 Mutation or Those Who Have Received a Prior B-cell Receptor Inhibitor (VENICE I) | Completed | USA | TUR | SWE | NOR | NLD | ITA | ISR | IRL | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CHE | CAN | BEL | AUT | 2 |
| NCT02055820 | Phase I | Venetoclax Rituximab Cyclophosphamide + Doxorubicin + Prednisone + Vincristine Sulfate Obinutuzumab | A Safety and Pharmacokinetics Study of GDC-0199 (ABT-199) in Patients With Non-Hodgkin's Lymphoma | Completed | USA | NLD | ITA | HUN | FRA | ESP | CZE | CAN | AUT | AUS | 0 |
| NCT03319901 | Phase I | Cytarabine Mercaptopurine Methotrexate Cyclophosphamide Venetoclax Doxorubicin Etoposide Vincristine Sulfate | Venetoclax and Chemotherapy In ALL | Recruiting | USA | 0 |
| NCT03214562 | Phase Ib/II | Venetoclax Cytarabine + Filgrastim + Fludarabine + Idarubicin + Venetoclax | Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive Acute Myeloid Leukemia (AML) Induction/Consolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia (AML) | Recruiting | USA | 0 |
| NCT03609593 | Phase II | Rituximab Bendamustine + Rituximab Venetoclax | Bendamustine/Rituximab Followed by Venetoclax and Rituximab for Treatment of Chronic Lymphocytic Leukemia | Active, not recruiting | USA | 0 |
| NCT02005471 | Phase III | Venetoclax Bendamustine Rituximab | A Study of GDC-0199 (ABT-199) Plus MabThera/Rituxan (Rituximab) Compared With Bendamustine Plus MabThera/Rituxan (Rituximab) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia | Completed | USA | SWE | POL | NZL | NLD | ITA | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BEL | AUT | AUS | 3 |
| NCT05360160 | Phase Ib/II | Decitabine and Cedazuridine Revumenib Venetoclax | A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE) | Recruiting | USA | 0 |
| NCT02141282 | Phase II | Venetoclax | A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy | Completed | USA | 0 |
| NCT03534180 | Phase II | Venetoclax | Venetoclax in Treating Participants With Recurrent or Refractory Mature T-Cell Lymphoma | Completed | USA | 0 |
| NCT06668558 | Phase II | Venetoclax Azacitidine + Venetoclax | Venetoclax + Azacitidine in Patients with Acute Myeloid Leukemia (VERDI) | Not yet recruiting | ESP | 0 |
| NCT01889186 | Phase II | Venetoclax | A Study of the Efficacy of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia With the 17p Deletion | Completed | USA | POL | GBR | FRA | DEU | CAN | AUS | 0 |
| NCT01794520 | Phase I | Venetoclax | Study Evaluating ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma | Completed | USA | NOR | FRA | BEL | 0 |
| NCT06311227 | Phase II | Venetoclax | Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia | Recruiting | USA | 0 |
| NCT05386576 | Phase I | Venetoclax | A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) | Active, not recruiting | USA | 0 |
| NCT04070768 | Phase I | Gemtuzumab ozogamicin + Venetoclax Venetoclax | Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113 | Active, not recruiting | USA | 0 |
| NCT03236857 | Phase I | Venetoclax | A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies | Completed | USA | NLD | GBR | FRA | DEU | CHE | CAN | AUS | 0 |
| NCT03573024 | Phase II | Venetoclax Azacitidine | Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia | Active, not recruiting | USA | 0 |
| NCT04419519 | Phase II | Venetoclax | Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax | Recruiting | USA | 0 |
| NCT03986034 | Phase II | Venetoclax | Early Clonal Dynamics During Venetoclax Treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) | Recruiting | USA | 0 |
| NCT05701215 | Phase II | Venetoclax | Venetoclax After TKI to Target Persisting Stem Cells in CML (VARIANT) | Recruiting | DEU | 0 |
| NCT05431257 | Phase II | Azacitidine + Venetoclax Venetoclax | Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML Profiling (LD-VenEx) | Recruiting | DNK | 0 |
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