A Phase 1 interventional study of Group 1: TK216 and Group 2: TK216 in Recurrent Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-06.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
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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Exclusion Criteria:
Patients receive TK216 IV continuously on days 1-7 every 21 days.
Drug: Group 1: TK216
Patients receive TK216 IV on days 1-7 and 15-21 every 28 days.
Drug: Group 2: TK216
Patients receive recommended dose of TK216 from Part 1 plus Decitabine.
Drug: Part 2: Decitabine 10mg/m2 · Drug: Part 2: TK216
Patients receive recommended dose of TK216 from Part 1 plus Decitabine.
Drug: Part 2: Decitabine 20 mg/m2 · Drug: Part 2: TK216
All patients in the expansion cohort will receive the RP2D of TK216 and Decitabine.
Drug: Expansion Phase TK216 · Drug: Expansion Phase Decitabine
Starting Dose: 288 mg/m2 given by vein on Days 1-7 of a 21 day cycle.
Starting Dose: 144 mg/m2 given by vein on Days 1-7 and 15-21 of a 23 day cycle.
Also known as: TK-216, TK216
10mg/m2 by vein on Days 1-10 of a 28 day cycle.
Also known as: Dacogen
20 mg/m2 by vein on Days 1-10 of a 28 dayi cycle.
Also known as: Dacogen
Expansion cohort will receive the RP2D of TK216
Expansion cohort will receive the RP2D of Decitabine
Also known as: Dacogen
Recommended dose from Part 1.
Incidence of adverse events
Will be tabulated with frequency and percentage by grade, attribution to treatment, and by dose level/schedule.
Time frame: Up to 30 days
Response rate
Will be estimated alone with 95% confidence interval.
Time frame: Up to 30 days
Overall survival
Will be estimated using the Kaplan-Meier method.
Time frame: Up to 1 year
Disease free survival
Will be estimated using the Kaplan-Meier method.
Time frame: Up to 1 year
Duration of disease control
Will be estimated using the Kaplan-Meier method.
Time frame: Up to 1 year
No study locations are listed for this record.
This study is withdrawn, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center