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

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

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

Sponsors & Collaborators

• Janssen Pharmaceuticals

  collaborator INDUSTRY

• National Institutes of Health (NIH)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• John Welch, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-14

Primary Completion

2021-02-13

Completion

2022-03-16

FDA Drug

Yes

Countries

• United States

Study Locations