Ongoing clinical trials with novel single-agent or combination therapies in AML
| Population/indication . | Treatment . | Phase . | Identifier . |
|---|---|---|---|
| Venetoclax | |||
| Untreated AML older patients unfit for IC | Azacitidine ± venetoclax | Phase 3 | NCT02993523 |
| Untreated AML older patients unfit for IC | LDAC ± venetoclax | Phase 3 | NCT03069352 |
| Untreated AML older patients unfit for IC | Azacitidine + venetoclax | Phase 2 | NCT03466294 |
| Untreated AML older patients unfit for IC | Decitabine 10 d + venetoclax | Phase 2 | NCT03404193 |
| Untreated AML older patients unfit for IC | LDAC + cladribine + azacitidine + venetoclax | Phase 2 | NCT03586609 |
| Untreated or R/R AML patients fit for IC | FLAG-Ida + venetoclax | Phase 2 | NCT03214562 |
| Untreated or R/R AML patients fit for IC | Fludarabine + cytarabine + idarubicin + venetoclax | Phase 2 | NCT03455504 |
| Untreated or R/R AML patients fit for IC | CPX-351 + venetoclax | Phase 2 | NCT03629171 |
| Untreated AML patients fit for IC | 7 + 3 + venetoclax | Phase 1b | NCT03709758 |
| Untreated AML older patients unfit for IC | Azacitidine + venetoclax + pevonedistat | Phase 1/2 | NCT03862157 |
| Untreated AML patients 18 to 59 y old | Azacitidine + venetoclax | Phase 2 | NCT03573024 |
| R/R AML | Venetoclax + dinaciclib | Phase 1b | NCT03484520 |
| R/R AML | Venetoclax + alvocidib | Phase 1b | NCT03441555 |
| R/R AML | Venetoclax + ruxolitinib | Phase 1 | NCT03874052 |
| R/R AML | Venetoclax + gilteritinib | Phase 1 | NCT03625505 |
| R/R AML | Venetoclax + AMG-176 (MCL1 inhibitor) | Phase 1b | NCT03797261 |
| R/R AML | Venetoclax + S64315 (MCL1 inhibitor) | Phase 1 | NCT03672695 |
| R/R AML | Venetoclax + cobimetinib or venetoclax + idasanutlin | Phase 1b/2 | NCT02670044 |
| R/R AML | Venetoclax + lintuzumab-225Ac | Phase 1/2 | NCT03867682 |
| R/R AML | CPX-351 + venetoclax | Phase 1 | NCT03826992 |
| R/R AML, FLT3 mutated | Venetoclax + quizartinib | Phase 1b/2 | NCT03735875 |
| Ivosidenib or enasidenib | |||
| Untreated AML patients fit for IC | Intensive chemotherapy + ivosidenib or enasidenib | Phase 1 | NCT02632708 |
| Untreated AML patients fit for IC | Intensive chemotherapy + ivosidenib or enasidenib | Phase 3 | NCT03839771 |
| Untreated AML older patients unfit for IC | Azacitidine + ivosidenib or azacitidine + enasidenib | Phase 1/2 | NCT02677922 |
| Untreated AML older patients unfit for IC | Enasidenib vs azacitidine, LDAC, or intermediate-dose cytarabine | Phase 3 | NCT02577406 |
| Untreated AML older patients unfit for IC | Azacitidine + ivosidenib or placebo | Phase 3 | NCT03173248 |
| Untreated or R/R AML | Venetoclax + ivosidenib ± azacitidine | Phase 1/2 | NCT03471260 |
| R/R AML | Azacitidine + enasidenib | Phase 2 | NCT03683433 |
| R/R AML | CPX-351 + enasidenib | Phase 2 | NCT03825796 |
| Post-HSCT maintenance | Enasidenib | Phase 1 | NCT03515512 |
| Post-HSCT maintenance | Enasidenib | Phase 1 | NCT03728335 |
| Glasdegib | |||
| Untreated AML patients fit for IC | IC ± glasdegib | Phase 3 | NCT03416179 |
| Untreated AML older patients unfit for IC | Azacitidine ± glasdegib | Phase 3 | NCT03416179 |
| Untreated AML older patients unfit for IC | Azacitidine + glasdegib | Phase 1b | NCT02367456 |
| Untreated or R/R AML | Glasdegib + GO | Phase 1 | NCT03390296 |
| Untreated AML patients fit for IC | Intensive chemotherapy + glasdegib | Phase 1 | NCT02038777 |
| Untreated AML older patients unfit for IC | LDAC + glasdegib | Phase 1 | NCT02038777 |
| Untreated AML older patients unfit for IC | Azacitidine or decitabine + glasdegib | Phase 2 | NCT03226418 |
| Untreated AML older patients unfit for IC | Decitabine + glasdegib | Phase 2 | NCT01546038 |
| Liposome-encapsulated cytarabine plus daunorubicin combination (CPX-351) | |||
| Untreated AML patients fit for IC | CPX-351 vs standard IC | Phase 3 | NCT03897127 |
| Untreated AML older patients fit for IC | CPX-351 vs DA + GO | Phase 3 | NCT02272478 |
| Untreated t-AML or AML-MRC | CPX-351 + palbociclib | Phase 1/2 | NCT03844997 |
| Untreated AML secondary to MPN | CPX-351 + ruxolitinib | Phase 1/2 | NCT03878199 |
| Untreated AML older patients fit for IC | CPX-351 + GO | Phase 1 | NCT03878927 |
| R/R AML | CPX-351 + GO | Phase 1 | NCT03672539 |
| R/R AML | CPX-351 + GO | Phase 1 | NCT03904251 |
| R/R AML | CPX-351 | Phase 2 | NCT00822094 |
| GO | |||
| Untreated AML patients fit for IC | GCLAM + GO | Phase 1/2 | NCT03531918 |
| Untreated AML, FLT3 mutated, patients fit for IC | 7 + 3 + GO + midostaurin | Phase 1 | NCT03900949 |
| Untreated CBF AML patients fit for IC | FLAG-Ida + GO | Phase 2 | NCT00801489 |
| MRD positivity | GO single agent | Phase 2 | NCT03737955 |
| R/R AML | Mitoxantrone + etoposide + GO | Phase 2 | NCT03839446 |
| R/R AML | Pracinostat + GO | Phase 1 | NCT03848754 |
| Population/indication . | Treatment . | Phase . | Identifier . |
|---|---|---|---|
| Venetoclax | |||
| Untreated AML older patients unfit for IC | Azacitidine ± venetoclax | Phase 3 | NCT02993523 |
| Untreated AML older patients unfit for IC | LDAC ± venetoclax | Phase 3 | NCT03069352 |
| Untreated AML older patients unfit for IC | Azacitidine + venetoclax | Phase 2 | NCT03466294 |
| Untreated AML older patients unfit for IC | Decitabine 10 d + venetoclax | Phase 2 | NCT03404193 |
| Untreated AML older patients unfit for IC | LDAC + cladribine + azacitidine + venetoclax | Phase 2 | NCT03586609 |
| Untreated or R/R AML patients fit for IC | FLAG-Ida + venetoclax | Phase 2 | NCT03214562 |
| Untreated or R/R AML patients fit for IC | Fludarabine + cytarabine + idarubicin + venetoclax | Phase 2 | NCT03455504 |
| Untreated or R/R AML patients fit for IC | CPX-351 + venetoclax | Phase 2 | NCT03629171 |
| Untreated AML patients fit for IC | 7 + 3 + venetoclax | Phase 1b | NCT03709758 |
| Untreated AML older patients unfit for IC | Azacitidine + venetoclax + pevonedistat | Phase 1/2 | NCT03862157 |
| Untreated AML patients 18 to 59 y old | Azacitidine + venetoclax | Phase 2 | NCT03573024 |
| R/R AML | Venetoclax + dinaciclib | Phase 1b | NCT03484520 |
| R/R AML | Venetoclax + alvocidib | Phase 1b | NCT03441555 |
| R/R AML | Venetoclax + ruxolitinib | Phase 1 | NCT03874052 |
| R/R AML | Venetoclax + gilteritinib | Phase 1 | NCT03625505 |
| R/R AML | Venetoclax + AMG-176 (MCL1 inhibitor) | Phase 1b | NCT03797261 |
| R/R AML | Venetoclax + S64315 (MCL1 inhibitor) | Phase 1 | NCT03672695 |
| R/R AML | Venetoclax + cobimetinib or venetoclax + idasanutlin | Phase 1b/2 | NCT02670044 |
| R/R AML | Venetoclax + lintuzumab-225Ac | Phase 1/2 | NCT03867682 |
| R/R AML | CPX-351 + venetoclax | Phase 1 | NCT03826992 |
| R/R AML, FLT3 mutated | Venetoclax + quizartinib | Phase 1b/2 | NCT03735875 |
| Ivosidenib or enasidenib | |||
| Untreated AML patients fit for IC | Intensive chemotherapy + ivosidenib or enasidenib | Phase 1 | NCT02632708 |
| Untreated AML patients fit for IC | Intensive chemotherapy + ivosidenib or enasidenib | Phase 3 | NCT03839771 |
| Untreated AML older patients unfit for IC | Azacitidine + ivosidenib or azacitidine + enasidenib | Phase 1/2 | NCT02677922 |
| Untreated AML older patients unfit for IC | Enasidenib vs azacitidine, LDAC, or intermediate-dose cytarabine | Phase 3 | NCT02577406 |
| Untreated AML older patients unfit for IC | Azacitidine + ivosidenib or placebo | Phase 3 | NCT03173248 |
| Untreated or R/R AML | Venetoclax + ivosidenib ± azacitidine | Phase 1/2 | NCT03471260 |
| R/R AML | Azacitidine + enasidenib | Phase 2 | NCT03683433 |
| R/R AML | CPX-351 + enasidenib | Phase 2 | NCT03825796 |
| Post-HSCT maintenance | Enasidenib | Phase 1 | NCT03515512 |
| Post-HSCT maintenance | Enasidenib | Phase 1 | NCT03728335 |
| Glasdegib | |||
| Untreated AML patients fit for IC | IC ± glasdegib | Phase 3 | NCT03416179 |
| Untreated AML older patients unfit for IC | Azacitidine ± glasdegib | Phase 3 | NCT03416179 |
| Untreated AML older patients unfit for IC | Azacitidine + glasdegib | Phase 1b | NCT02367456 |
| Untreated or R/R AML | Glasdegib + GO | Phase 1 | NCT03390296 |
| Untreated AML patients fit for IC | Intensive chemotherapy + glasdegib | Phase 1 | NCT02038777 |
| Untreated AML older patients unfit for IC | LDAC + glasdegib | Phase 1 | NCT02038777 |
| Untreated AML older patients unfit for IC | Azacitidine or decitabine + glasdegib | Phase 2 | NCT03226418 |
| Untreated AML older patients unfit for IC | Decitabine + glasdegib | Phase 2 | NCT01546038 |
| Liposome-encapsulated cytarabine plus daunorubicin combination (CPX-351) | |||
| Untreated AML patients fit for IC | CPX-351 vs standard IC | Phase 3 | NCT03897127 |
| Untreated AML older patients fit for IC | CPX-351 vs DA + GO | Phase 3 | NCT02272478 |
| Untreated t-AML or AML-MRC | CPX-351 + palbociclib | Phase 1/2 | NCT03844997 |
| Untreated AML secondary to MPN | CPX-351 + ruxolitinib | Phase 1/2 | NCT03878199 |
| Untreated AML older patients fit for IC | CPX-351 + GO | Phase 1 | NCT03878927 |
| R/R AML | CPX-351 + GO | Phase 1 | NCT03672539 |
| R/R AML | CPX-351 + GO | Phase 1 | NCT03904251 |
| R/R AML | CPX-351 | Phase 2 | NCT00822094 |
| GO | |||
| Untreated AML patients fit for IC | GCLAM + GO | Phase 1/2 | NCT03531918 |
| Untreated AML, FLT3 mutated, patients fit for IC | 7 + 3 + GO + midostaurin | Phase 1 | NCT03900949 |
| Untreated CBF AML patients fit for IC | FLAG-Ida + GO | Phase 2 | NCT00801489 |
| MRD positivity | GO single agent | Phase 2 | NCT03737955 |
| R/R AML | Mitoxantrone + etoposide + GO | Phase 2 | NCT03839446 |
| R/R AML | Pracinostat + GO | Phase 1 | NCT03848754 |
CBF, core binding factor; DA, daunorubicin plus cytarabine; GCLAM, G-CSF, cladribine, cytarabine, mitoxantrone; IC, intensive chemotherapy; MPN, myeloproliferative neoplasm; R/R, relapsed or refractory; t-AML, therapy-related acute myeloid leukemia.