ACY-1215 for Relapsed/Refractory Lymphoid Malignancies
Status:
Completed
Trial end date:
2019-05-05
Target enrollment:
Participant gender:
Summary
This will be an open-label, single agent, multi-institutional phase Ib/II study of ACY-1215
for the treatment of patients with relapsed or refractory lymphoid malignancies. The target
population will include patients with histologically confirmed relapsed or refractory
non-Hodgkin's lymphoma or Hodgkin's lymphoma, with an expansion cohort of patients with
mantle cell lymphoma.
The phase Ib will be conducted to determine the safety and tolerability of two dosing
schedules of ACY-1215 monotherapy in patients with lymphoid malignancies. Patients will be
accrued simultaneously to two dose cohorts (Arm A and Arm B) of ACY-1215. Selection into each
cohort will occur by alternation. All patients will take the prescribed dose of ACY-1215
orally for 28 consecutive days. Patients enrolled into Arm A will take ACY-1215 160 mg daily
(QD), whereas patients enrolled into Arm B will take ACY-1215 160 mg twice daily (BID).
ACY-1215 will be supplied as a liquid for oral administration (PO). Each dose will be
administered at least 1 hour after ingestion of food followed by at least 4 ounces of water.
Patients will be instructed not to ingest food or other oral medication for at least 2 hours
after each ACY-1215 dose. Frequency in phase II will be determined based on Phase Ib results.