Refractory Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I Study of TK216 in Patients With Relapsed and Refractory Leukemias
This phase I trial studies the side effects and best dose of TK216 and decitabine when given together in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as TK216 and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of
Ets-family transcription factor inhibitor TK216 (TK216) in patients with relapsed and
refractory (R/R) acute myeloid leukemia (AML). (Phase I Dose Escalation) II. To determine the
safety and tolerability of TK216 combined with decitabine in patients with relapsed and
refractory AML. (Combination Cohort)
SECONDARY OBJECTIVES:
I. Safety profile of TK216 as characterized by adverse event (AE) type, severity, timing and
relationship to study drug, as well as laboratory abnormalities in the first and subsequent
treatment cycles. (Phase I Dose Escalation) II. To explore the efficacy (complete remission
[CR], complete remission without platelet recovery [CRp], complete remission without blood
count recovery [CRi], or partial remission [PR]), of TK216 as a single-agent in patients with
R/R AML. (Phase I Dose Escalation) III. To assess overall survival (OS), and disease free
survival (DFS) in patients with R/R AML treated with TK216. (Phase I Dose Escalation) IV.
Duration of disease control defined as first date of disease control identified (either
CR/CRp/CRi, PR or SD) until the date of progression. (Phase I Dose Escalation) V. To explore
biomarkers of response and resistance in patients with R/R AML treated with TK216. (Phase I
Dose Escalation) VI. Safety profile of TK216 in combination with decitabine as characterized
by adverse event (AE) type, severity, timing and relationship to study drug, as well as
laboratory abnormalities in the first and subsequent treatment cycles. (Combination Cohort)
VII. To explore the efficacy (complete remission [CR], complete remission without platelet
recovery [CRp], complete remission without blood count recovery [CRi], or partial remission
[PR], of TK216 in combination with decitabine in patients with R/R AML. (Combination Cohort)
VIII. To assess overall survival (OS), and progression free survival (PFS) in patients with
R/R AML treated with TK216 + decitabine. (Combination Cohort) IX. Duration of disease control
defined as first date of disease control identified (either CR/CRp/CRi, PR or SD) until the
date of progression. (Combination Cohort) X. To explore biomarkers of response and resistance
in patients with R/R AML treated with TK216 + decitabine. (Combination Cohort)
OUTLINE: This is a dose-escalation study.
Patients receive TK216 intravenously (IV) continuously on days 1-7 every 21 days, or
continuously on days 1-7 and 15-21 every 28 days. Patients also receive decitabine IV over 60
minutes on days 1-10 every 28 days. Treatment continues in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
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