Table 1.
Ongoing clinical trials using BCL-2 Inhibitors in Acute Myeloid Leukaemia.
| Clinicaltrials.gov Identifier | Target Group | Phase | Trial |
|---|---|---|---|
| NCT03484520 | R/R AML (age ≥ 18) | I | A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia |
| NCT03441555 | R/R AML (age ≥ 18) | I | A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia |
| NCT02993523 | AML (age ≥ 18; treatment-naïve) | III | A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment-Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy |
| NCT03874052 | R/R AML (age ≥ 18) | I | Ruxolitinib in Combination With Venetoclax for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia |
| NCT03625505 | R/R AML (age ≥ 18) | I | A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia |
| NCT03573024 | AML (ages 18–59; treatment-naïve) | II | Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia |
| NCT03069352 | AML (age ≥ 18; treatment-naïve) | III | 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 |
| NCT03672695 | R/R AML (age ≥ 18) | I | Phase I Dose Escalation Study of Intravenously Administered S64315 (Mcl-1 Inhibitor) in Combination With Orally Administered Venetoclax in Patients With Acute Myeloid Leukaemia |
| NCT03844815 | High risk AML (R/R AML, TP53 mutant, adverse cytogenetics; age ≥ 18) | I | Study of Venetoclax in Combination With Decitabine in Subjects With Acute Myeloid Leukemia |
| NCT03214562 | Treatment naive and R/R AML (age ≥ 18) | I/II | 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) |
| NCT03709758 | AML (age 18–75; treatment-naïve) | I | Venetoclax in Combination With Intensive Induction and Consolidation Chemotherapy in Treatment-Naïve AML |
| NCT03466294 | AML (age ≥ 60; treatment-naïve) | II | Azacitidine and Venetoclax as Induction Therapy With Venetoclax Maintenance in the Elderly With AML |
| NCT03629171 | R/R AML (age ≥ 18) with dose expansion cohort B for treatment-naïve | II | Liposome-encapsulated Daunorubicin-Cytarabine (CPX-351) and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia |
| NCT03455504 | AML (age 18–65; treatment-naïve) | II | Venetoclax Add in Combination With Fludarabine, Cytarabine and Idarubicin in Induction for Acute Myeloid Leukemia (V-FIRST) |
| NCT03586609 | AML (age ≥ 60; treatment-naïve) | II | Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Participants With Patients Previously Untreated Acute Myeloid Leukemia |
| NCT03735875 | R/R AML (age 18–65) | I/II | Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukaemia |
| NCT02670044 | R/R AML (age ≥ 60) | I/II | A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients Aged >/= 60 Years With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy |
| NCT03797261 | R/R AML and R/R NHL/DLBCL (age ≥ 18) | I | A Study of Venetoclax and AMG 176 (MCL1 inhibitor) in Patients With Relapsed/Refractory Hematologic Malignancies |
| NCT03862157 | Treatment naïve AML with a history of MDS, MPN, MDS/MPN, CNL, aCML, CEL (age ≥ 18) | I/II | Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT03471260 | R/R AML (age ≥ 18) | I/II | Study of Venetoclax With the mIDH1 Inhibitor Ivosidenib (AG120) in IDH1-Mutated Hematologic Malignancies |
| NCT03613532 | High risk AML, MDS, MDS/MPN (age ≥ 18) going to Allogeneic SCT | I | Venetoclax Added to Fludarabine + Busulfan Prior to Transplant for AML, MDS, and MDS/MPN |
Abbreviations: R/R, relapsed/refractory; AML, acute myeloid leukemia; MDS, myelodysplastic syndrome; MPN, myeloproliferative neoplasm; AUL, acute undifferentiated leukaemia; MPAL, mixed phenotypic acute leukaemia; CNL, chronic neutrophilic leukaemia; CEL, chronic eosinophilic leukaemia; aCML, atypical chronic myeloid leukaemia; NHL, non-Hodgkin lymphoma; DLBCL, diffuse large B cell lymphoma; SCT, stem cell transplant.