Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia | Aplastic Anemia & MDS International Foundation
Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia

Clinical Trial: NCT03063203

For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

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.

Status: 
Recruiting
Study Date: 
Fri, 07/14/2017 to Thu, 07/31/2025
Bone Marrow Disease(s): 
  • acute myeloid leukemia (AML)
Associated Drug(s): 
Intervention: 
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. Other Name: 5-aza-2'-deoxycytidine 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