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

PHASE2TerminatedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

July 14, 2017

Primary Completion Date

February 13, 2021

Study Completion Date

March 16, 2022

Conditions
Acute Myeloid LeukemiaAcute Myeloid Leukemia, Relapsed, Adult
Interventions
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

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Janssen Pharmaceuticals

INDUSTRY

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

Washington University School of Medicine

OTHER