The purpose of this study is to define a safe dose of AC220 when given as maintenance therapy after treatment with an allogeneic stem cell transplant.
This is a two-part, sequential group dose escalation study. In Part 1, subjects will be enrolled into successive cohorts to determine the maximum tolerated dose (MTD). Dose escalation decision will be made based on dose limiting toxicities (DLTs) that occur in subjects treated to date at a given dose level. In Part 2, a confirmation cohort will be opened to confirm the safety at the MTD. Subjects who have had an allogeneic Hematopoietic Stem Cell Transplant (HSCT) will enter treatment with AC220 between 30 to 60 days after receiving allogeneic HSCT. AC220 will be administered every day, with 28 consecutive days defined as a treatment cycle. Subjects may receive up to 24 continuous treatment cycles. Subjects will have study visits each week for the first 2 cycles, and then on Day 1 of each cycle after that.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Oral Liquid
City of Hope
Duarte, California, United States
Northwestern University
Chicago, Illinois, United States
University of Minnesota
Minneapolis, Minnesota, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Incidence of dose limiting toxicity (DLT)
From first dose through last dose of Cycle 2
Time frame: up to Day 56
Safety assessed by recording adverse events, physical examinations, vital signs, electrocardiograms (ECGs) and laboratory assessments
Time frame: 30 days after last subject discontinues treatment (maximum of 24 months)
Duration of confirmed complete remission (CR)
Time from first dose until date of relapse
Time frame: 24 months
Duration of overall complete remission
Complete remission (CR) + CR with incomplete platelet recovery (CRp) + CR with incomplete hematologic recovery (CRi) + complete molecular remission (CRm)
Time frame: 24 months
Disease-free survival
Time from first dose until date of relapse or death
Time frame: 30 days after last subject discontinues treatment (maximum of 24 months)
Overall survival
Time from first dose until date of death from any cause
Time frame: 30 days after last subject discontinues treatment (maximum of 24 months)
Percentage of transplant rejections
Through End of Treatment
Time frame: 30 days after last subject discontinues treatment (maximum of 24 months)
Percentage of Subjects with Graft-versus-Host Disease (GVHD)
Time frame: Up through 24 months of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Seattle Cancer Care Alliance
Seattle, Washington, United States
Percentage of Donor Chimerism
Time frame: Up through 24 months of treatment
Treatment-related mortality (TRM)
Death in CR (CR, CRm, CRp and CRi)
Time frame: Up through 24 months of treatment
Composite of pharmacokinetics: AUC24 , Cmax, Ctrough and Tmax
Time frame: Up through 24 months of treatment