NCT03063203

Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia

An Open Label, Multicenter, Phase II Trial Testing Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators seek to determine whether decitabine therapy can improve outcomes, specifically overall survival this selected subset of acute myeloid leukemia (AML) patients with the poorest prognosis based on refractoriness to induction treatment and high risk genetic mutations.

Conditions

• Acute Myeloid Leukemia
• Acute Myeloid Leukemia, Relapsed, Adult

Interventions

Type	Name	Description
DRUG	Decitabine	* After 2 cycles, patients with progressive disease or relapse (a clear progression with at least \>20% bone marrow blasts and an increase of at least 50% from prior biopsy) should be removed from protocol and proceed to salvage treatment according to center preference * Transplant eligible patients who achieve CR, CRc, or CRi, after 3 cycles with a suitable donor will proceed to conditioning regimen and transplant * Transplant eligible patients with PR after 3 cycles may be removed from protocol and proceed to salvage treatment according to center preference * Transplant eligible patients with a suitable donor who achieve mLFS, CR, CRc, or CRi, may proceed to transplant after at 3 cycles * Transplant ineligible patients with (CR, CRc or CRi, PR) will continue on maintenance doses * Transplant ineligible patient with SD after cycle 4 may be removed from protocol and proceed to alternative treatment or continue on protocol according to treating physician's preference.
PROCEDURE	Bone marrow biopsy/aspirate	* Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression or relapse * Biopsy/aspirate on Cycle 1 Day 10 is for participants enrolled at Washington University only * Biopsy/aspirate on Cycle 2 Day 28 is at the discretion of the treating physician
PROCEDURE	Peripheral blood draw	-Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression/Relapse
PROCEDURE	Skin biopsy	* Optional but if refuse skin biopsy then participant can provided buccal swab * There is no required time frame for this sample - it may have been collected months or even years prior to the first dose of decitabine * If WBC at time of enrollment is \>30,000/µl, skin biopsy should be collected at the time of C1D28 bone marrow biopsy or thereafter
PROCEDURE	Buccal swab	-Baseline (if skin biopsy declined) and Cycle 2 Day 28

Timeline

• Start date: 2017-07-14
• Primary completion: 2021-02-13
• Completion: 2022-03-16
• First posted: 2017-02-24
• Last updated: 2022-06-02
• Results posted: 2022-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study