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TK216 and Decitabine in Treating Patients With Relapsed and Refractory Acute Myeloid Leukemia

NCT03752138 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Acute Myeloid Leukemia
  • Refractory Acute Myeloid Leukemia

Interventions

DRUG

Group 1: TK216

Starting Dose: 288 mg/m2 given by vein on Days 1-7 of a 21 day cycle.

DRUG

Group 2: TK216

Starting Dose: 144 mg/m2 given by vein on Days 1-7 and 15-21 of a 23 day cycle.

DRUG

Part 2: Decitabine 10mg/m2

10mg/m2 by vein on Days 1-10 of a 28 day cycle.

DRUG

Part 2: Decitabine 20 mg/m2

20 mg/m2 by vein on Days 1-10 of a 28 dayi cycle.

DRUG

Expansion Phase TK216

Expansion cohort will receive the RP2D of TK216

DRUG

Expansion Phase Decitabine

Expansion cohort will receive the RP2D of Decitabine

DRUG

Part 2: TK216

Recommended dose from Part 1.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Tapan Kadia · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03752138 on ClinicalTrials.gov