Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 6, 2023

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2030

Conditions
Leukemia, AcuteMyelodysplastic SyndromesMyelomonocytic Leukemia, ChronicT-cell Prolymphocytic LeukemiaCMLMyeloproliferative DisordersMultiple MyelomaPlasma Cell Leukemia
Interventions
DRUG

Itacitinib

A standard 3+3 design will be used to evaluate the safety of itacitinib plus different immunosuppression regimens. This study has four predefined Regimens that will be explored in the optimal Regimen-finding phase and are listed in Table 2 of the protocol. Itacitinib will be given in conjunction with each of four different regimens for immunosuppression. Regimen 1 is the current standard for our BMT patients, with a duration of MMF from day 5-35. Regimen 2 will decrease the duration of MMF from 35 to day 25. Regimen 3 will decrease the duration of MMF from 35 to day 15. Regimen 4 will eliminate MMF altogether. We will start with Regimen 1, which combines itacitinib with the current standard of immunosuppression. Progression through cohorts (Regimens) will be based on a standard 3+3 design to find the optimal regimen.

Trial Locations (1)

21231

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Incyte Corporation

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT05823571 - Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients | Biotech Hunter | Biotech Hunter