Clinical trial NCT03063203: Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia
Official title: An Open Label, Multicenter, Phase II Trial Testing Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia
Conditions: Acute Myeloid Leukemia
Acute Myeloid Leukemia, Relapsed, Adult
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.
Interventions:
description: * 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<br/>* Transplant eligible patients who achieve CR, CRc, or CRi, after 3 cycles with a suitable donor will proceed to conditioning regimen and transplant<br/>* Transplant eligible patients with PR after 3 cycles may be removed from protocol and proceed to salvage treatment according to center preference<br/>* Transplant eligible patients with a suitable donor who achieve mLFS, CR, CRc, or CRi, may proceed to transplant after at 3 cycles<br/>* Transplant ineligible patients with (CR, CRc or CRi, PR) will continue on maintenance doses<br/>* 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.
name: Decitabine
other_name: 5-aza-2'-deoxycytidine
type: Drug
description: * Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression or relapse<br/>* Biopsy/aspirate on Cycle 1 Day 10 is for participants enrolled at Washington University only<br/>* Biopsy/aspirate on Cycle 2 Day 28 is at the discretion of the treating physician
name: Bone marrow biopsy/aspirate
type: Procedure
description: -Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression/Relapse
name: Peripheral blood draw
type: Procedure
description: * Optional but if refuse skin biopsy then participant can provided buccal swab<br/>* 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<br/>* 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
name: Skin biopsy
type: Procedure
description: -Baseline (if skin biopsy declined) and Cycle 2 Day 28
name: Buccal swab
type: Procedure
Study arms:
design_group_description: * Cycle 1: All patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle<br/>* Cycle 2: Patients with bone marrow blast counts < 5% may receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of a 28-day cycle. All other patients will receive decitabine 20 mg/m^2 IV infusion per day over one hour on Days 1-10 of a 28-day cycle.<br/>* Cycle 3 and subsequent cycles: All patients will receive 20 mg/m^2 IV infusion per day over one hour on Days 1-5 of the 28-day cycle
design_group_title: Decitabine
design_group_type: Experimental
Sponsor: Washington University School of Medicine
Collaborators: National Cancer Institute
Janssen Pharmaceuticals, Inc.
National Institutes of Health
Drug name mappings:
name: 地西他滨
lang: CN
name: Decitabine
lang: EN