Table 2.
Summary of the clinical trials of the drugs that inhibit the BCL2 family of proteins.
| Drug | Mechanism of action | Combination with | Related clinical trial | Number of participants | phase | Reference(s) or Clinicaltrials.gov identifier |
|---|---|---|---|---|---|---|
| Oblimersen | BCL2 antisense oligonucleotide | Gemtuzumab Ozogamicin | Oblimersen and Gemtuzumab Ozogamicin in Treating Older Patients with Relapsed Acute Myeloid Leukemia | N/A | 2 | NCT00017589 |
| Obatoclax mesylate | BH3 mimetic Binding to the BH3-binding site of BCL2, BCL2L1, BCL-W, BCL-B, MCL1, and A1 |
Vincristine Sulfate, Doxorubicin Hydrochloride, and Dexrazoxane Hydrochloride | Obatoclax Mesylate, Vincristine Sulfate, Doxorubicin Hydrochloride, and Dexrazoxane Hydrochloride in Treating Young Patients with Relapsed or Refractory Solid Tumors, Lymphoma, or Leukemia | 22 | 1 | NCT00933985 |
| Obatoclax mesylate | BH3 mimetic Binding to the BH3-binding site of BCL2, BCL2L1, BCL-W, BCL-B, MCL1, and A1 |
_____ | Study of Obatoclax in Previously Untreated Acute Myeloid Leukemia (AML) | 18 | 2 | NCT00684918 |
| Obatoclax mesylate | BH3 mimetic Binding to the BH3-binding site of BCL2, BCL2L1, BCL-W, BCL-B, MCL1, and A1 |
_____ | Obatoclax Mesylate in Samples from Young Patients with Acute Myeloid Leukemia | 50 | N/A | NCT01150656 |
| Obatoclax mesylate | BH3 mimetic Binding to the BH3-binding site of BCL2, BCL2L1, BCL-W, BCL-B, MCL1, and A1 |
_____ | Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the | 44 | 1 | NCT00438178 |
| Venetoclax | BH3 mimetic Inhibiting BCL2 and BCL-W |
Cytarabine | A Study of Venetoclax in Combination with Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment-Naive Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy | 211 | 3 | NCT03069352 |
| Venetoclax | BH3 mimetic Inhibiting BCL2 and BCL-W |
Cytarabine | A Study Evaluating Venetoclax in Combination with Low-Dose Cytarabine in Treatment-Naïve Participants with Acute Myelogenous Leukemia | 94 | 2 | NCT02287233 |
| Venetoclax | BH3 mimetic Inhibiting BCL2 and BCL-W |
Cladribine, Idarubicin, Cytarabine | Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients with Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia | 408 | 2 | NCT03586609 |
| Venetoclax | BH3 mimetic Inhibiting BCL2 and BCL-W |
Azacitidine, Decitabine | Study of ABT-199 (GDC-0199) in Combination with Azacitidine or Decitabine (Chemo Combo) in Subjects with Acute Myelogenous Leukemia (AML) | 52 | 2 | NCT05362942 |
| Venetoclax | BH3 mimetic Inhibiting BCL2 and BCL-W |
_____ | A Study to Describe the Safety and Effectiveness of Venetoclax in Acute Myeloid Leukemia (AML) Patients (REVIVE Study) (REVIVE) | 100 | N/A | NCT03987958 |
| Venetoclax | BH3 mimetic Inhibiting BCL2 and BCL-W |
_____ | A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation (INNOVATE) | 50 | N/A | NCT04253314 |
| Venetoclax | BH3 mimetic Inhibiting BCL2 and BCL-W |
_____ | Venetoclax Registry (VENreg) | 100 | N/A | NCT03662724 |
| Venetoclax | BH3 mimetic Inhibiting BCL2 and BCL-W |
_____ | A Phase 2 Study of ABT-199 in Subjects with Acute Myelogenous Leukemia (AML) | 32 | N/A | NCT01994837 |
| Venetoclax | BH3 mimetic Inhibiting BCL2 and BCL-W |
Azacitidine Rituximab/IDEC-C2B8 |
Study Evaluating Venetoclax in Subjects with Hematological Malignancies | 38 | 1/2 | NCT02265731 |
| Venetoclax | BH3 mimetic Inhibiting BCL2 and BCL-W |
_____ | An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial | 550 | 3 | NCT03844048 |
| Venetoclax | BH3 mimetic Inhibiting BCL2 and BCL-W |
_____ | Expanded Access to Venetoclax | N/A | N/A | NCT03123029 |
| AZD5991 | Selective MCL1 inhibitor | Venetoclax | Study of AZD5991 in Relapsed or Refractory Haematologic Malignancies. | 70 | 1 | NCT03218683 |
| Flavopiridol | Inhibiting MCL1 transcription | Cytarabine, Daunorubicin | Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7 + 3) in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML). | 32 | 1 | NCT03298984 |
| Flavopiridol | Inhibiting MCL1 transcription | mitoxantrone hydrochloride, Cytarabine | Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients with Newly Diagnosed Acute Myeloid Leukemia | 45 | 2 | NCT00407966 |
| Flavopiridol | Inhibiting MCL1 transcription | mitoxantrone hydrochloride, Cytarabine, Daunorubicin | Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients with Newly Diagnosed Acute Myeloid Leukemia | 172 | 2 | NCT01349972 |
| Flavopiridol | Inhibiting MCL1 transcription | mitoxantrone hydrochloride, Cytarabine | Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients with Relapsed or Refractory Acute Leukemia | 35 | 1 | NCT00470197 |
| Voruciclib | Inhibiting MCL1 transcription | _____ | A Phase 1 Study of Voruciclib in Subjects With B-Cell Malignancies or AML | 92 | 1 | NCT03547115 |
| BEZ235 | Inhibiting MCL1 translocation | _____ | A Phase I, Dose-finding Study of BEZ235 in Adult Patients with Relapsed | 23 | 1 | NCT01756118 |
| S64315 | MCL1 inhibitor | Azacitidine | Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukemia | 180 | 1/2 | NCT04629443 |
| S64315 | MCL1 inhibitor | Venetoclax | Phase I Dose Escalation Study of Intravenously Administered S64315 in Combination with Orally Administered Venetoclax in Patients with Acute Myeloid Leukemia. | 40 | 1 | NCT03672695 |
| S64315 | MCL1 inhibitor | ____ | Phase I Study of S64315 Administered Intravenously in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome | 38 | 1 | NCT02979366 |
| Sorafenib | Inhibiting MCL1 translocation | Selinexor | Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia | 17 | 2 | NCT02530476 |
| Sorafenib | Inhibiting MCL1 translocation | Asparaginase, Cytarabine, Bortezomib, Daunorubicin Hydrochloride, Etoposide, Mitoxantrone Hydrochloride | Bortezomib and Sorafenib Tosylate in Treating Patients with Newly Diagnosed Acute Myeloid Leukemia | 1645 | 3 | NCT01371981 |
| Sorafenib | Inhibiting MCL1 translocation | Azacitidine | Sorafenib Plus 5-Azacitidine Initial Therapy of Patients with Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic | 16 | 2 | NCT02196857 |
| Sorafenib | Inhibiting MCL1 translocation | Cytarabine | Sorafenib and Low Dose Cytarabine in Older Patients with Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | 21 | 2 | NCT00516828 |
| Sorafenib | Inhibiting MCL1 translocation | Azacitidine | Sorafenib and 5-Azacitidine in Acute leukemia + Myelodysplastic Syndrome | 60 | 2 | NCT01254890 |
| Sorafenib | Inhibiting MCL1 translocation | Azacitidine Cytarabine, Daunorubicin Hydrochloride |
Sorafenib Tosylate and Chemotherapy in Treating Older Patients with Acute Myeloid Leukemia | 54 | 2 | NCT01253070 |