Active trials for drug maintenance therapy after HCT for AML or MDS
| ClinicalTrials.gov identifier . | Phase . | Status . | Drug/schedule . | N . | Age . | Primary outcome . |
|---|---|---|---|---|---|---|
| Post-HCT FLT3-ITD maintenance | ||||||
| NCT02997202, CTN 1506 | 3 | Active, not recruiting | Gilteritinib 120 mg daily vs placebo for 2 years | 356 | >18 | 96-month RFS |
| NCT03690115, PONALLO trial | 2 | Active, not recruiting | Ponatinib 30 mg daily for 1 year | 77 | 18-70 | 24-month RFS |
| Post-HCT IDH 1/2 maintenance | ||||||
| NCT03728335 | 1 | Active, not recruiting | Enasidenib (dose unspecified) daily Q28 days for 24 cycles | 15 | >18 | Incidence of AEs |
| NCT03564821 | 1 | Active, not recruiting | Ivosidenib 500 mg daily dose escalation study | 18 | 18-75 | MTD |
| NCT04522895 | 2 | Active, not recruiting | Enasidenib 100 mg daily Q28 days for 12 cycles | 50 | >18 | Incidence of AEs |
| Post-HCT HMA-based maintenance | ||||||
| NCT01995578 | 2 | Active, not recruiting | Azacitadine 32 mg/m2 Q5 days every 28 days starting days +60-120 post-HCT up to 1 year post-HCT for ~8-10 cycles | 32 | 1-75 | 24-month relapse rate |
| NCT04173533 | 3 | Recruiting | Oral azacitidine (CC-486) 14 days for each 28-day cycle for 12 cycles | 324 | ≥16 | 12-month RFS |
| NCT03613532 | 1 | Recruiting | Azacitidine 5 doses with venetoclax 14 doses for 8-12 cycles or oral decitabine/cedazuridine 3 doses with venetoclax 14 doses for 8 cycles | 68 | ≥18 | MTD |
| NCT04128501 | 2 | Recruiting | Azacitidine days 1-5 + venetoclax days 1-7 Q4-8 weeks for up to 12 cycles. Dosing unspecified | 125 | 18-75 | RFS |
| NCT04161885, VIALE-T | 3 | Recruiting | Azacitidine days 1-5 + venetoclax days 1-28 Q28 for 6 cycles. Dosing unspecified | 424 | >18 | MTD and RFS |
| NCT03843528 | 1 | Recruiting | Azacitidine days 1-5 Q28 days. Vorinostat concurrently on days 1-7 and 15-21 of 28-day cycles up to 1 year | 15 | 1-21 | MTD |
| NCT04980404 | 1 | Recruiting | Decitabine/cedazuridine on days 1-3 Q42 days | 22 | ≥18 | DLT |
| Additional disease-based maintenance approaches | ||||||
| NCT03267186 | 2 | Active, not recruiting | Ibrutinib PO daily up to 18 months post-HCT | 8 | 18-70 | 18-month relapse rate |
| NCT03932643 | 1 | Recruiting | Onc201 at various dose levels weekly for up to 52 weeks | 20 | ≥19 | MTD |
| NCT04168502 | 3 | Recruiting | Glasdegib 100 mg daily for 1 year vs clinical observation | 414 | 18-60 | DFS |
| NCT03286530 | 2 | Recruiting | Ruxolitinib orally twice daily Q28 days for up to 24 cycles | 64 | 60-80 | 12-month GRFS rate |
| ClinicalTrials.gov identifier . | Phase . | Status . | Drug/schedule . | N . | Age . | Primary outcome . |
|---|---|---|---|---|---|---|
| Post-HCT FLT3-ITD maintenance | ||||||
| NCT02997202, CTN 1506 | 3 | Active, not recruiting | Gilteritinib 120 mg daily vs placebo for 2 years | 356 | >18 | 96-month RFS |
| NCT03690115, PONALLO trial | 2 | Active, not recruiting | Ponatinib 30 mg daily for 1 year | 77 | 18-70 | 24-month RFS |
| Post-HCT IDH 1/2 maintenance | ||||||
| NCT03728335 | 1 | Active, not recruiting | Enasidenib (dose unspecified) daily Q28 days for 24 cycles | 15 | >18 | Incidence of AEs |
| NCT03564821 | 1 | Active, not recruiting | Ivosidenib 500 mg daily dose escalation study | 18 | 18-75 | MTD |
| NCT04522895 | 2 | Active, not recruiting | Enasidenib 100 mg daily Q28 days for 12 cycles | 50 | >18 | Incidence of AEs |
| Post-HCT HMA-based maintenance | ||||||
| NCT01995578 | 2 | Active, not recruiting | Azacitadine 32 mg/m2 Q5 days every 28 days starting days +60-120 post-HCT up to 1 year post-HCT for ~8-10 cycles | 32 | 1-75 | 24-month relapse rate |
| NCT04173533 | 3 | Recruiting | Oral azacitidine (CC-486) 14 days for each 28-day cycle for 12 cycles | 324 | ≥16 | 12-month RFS |
| NCT03613532 | 1 | Recruiting | Azacitidine 5 doses with venetoclax 14 doses for 8-12 cycles or oral decitabine/cedazuridine 3 doses with venetoclax 14 doses for 8 cycles | 68 | ≥18 | MTD |
| NCT04128501 | 2 | Recruiting | Azacitidine days 1-5 + venetoclax days 1-7 Q4-8 weeks for up to 12 cycles. Dosing unspecified | 125 | 18-75 | RFS |
| NCT04161885, VIALE-T | 3 | Recruiting | Azacitidine days 1-5 + venetoclax days 1-28 Q28 for 6 cycles. Dosing unspecified | 424 | >18 | MTD and RFS |
| NCT03843528 | 1 | Recruiting | Azacitidine days 1-5 Q28 days. Vorinostat concurrently on days 1-7 and 15-21 of 28-day cycles up to 1 year | 15 | 1-21 | MTD |
| NCT04980404 | 1 | Recruiting | Decitabine/cedazuridine on days 1-3 Q42 days | 22 | ≥18 | DLT |
| Additional disease-based maintenance approaches | ||||||
| NCT03267186 | 2 | Active, not recruiting | Ibrutinib PO daily up to 18 months post-HCT | 8 | 18-70 | 18-month relapse rate |
| NCT03932643 | 1 | Recruiting | Onc201 at various dose levels weekly for up to 52 weeks | 20 | ≥19 | MTD |
| NCT04168502 | 3 | Recruiting | Glasdegib 100 mg daily for 1 year vs clinical observation | 414 | 18-60 | DFS |
| NCT03286530 | 2 | Recruiting | Ruxolitinib orally twice daily Q28 days for up to 24 cycles | 64 | 60-80 | 12-month GRFS rate |
Accessed on April 23, 2023, using search terms “maintenance post allogeneic transplant,” “maintenance post allo transplant,” “maintenance post allo aml or mds” and “relapse prevention after allo.”
AE, adverse events; DLT, dose limiting toxicity; DFS, disease free survival; MTD, maximum tolerated dose; Q, every.