Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT01846624 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2018-09-27
Summary
This phase 2 study evaluates the sequential combination of decitabine then midostaurin for the treatment of newly-diagnosed acute myeloid leukemia (AML) in older patients.
Conditions
- Acute Myeloid Leukemia (AML) With Multilineage Dysplasia Following Myelodysplastic Syndrome, in Adults
- AML (Adult) With 11q23 (MLL) Abnormalities
- AML (Adult) With Del (5q)
- AML (Adult) With Inv (16) (p13; q22)
- AML (Adult) With t (16;16) (p13; q22)
- AML (Adult) With t (8; 21) (q22; q22)
- Secondary AML (Adult)
- Untreated AML (Adult)
Interventions
- DRUG
-
Decitabine
Given IV
- DRUG
-
Midostaurin
Given PO
Sponsors & Collaborators
-
David Iberri
lead OTHER
Principal Investigators
-
David J Iberri, MD · Stanford University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2016-07-22
- Completion
- 2016-08-31
Countries
- United States
Study Locations
More Related Trials
-
Study of Decitabine in Combination With Sequential Rapamycin or Ribavirin in High Risk AML Patients
NCT02109744 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)
NCT00358644 ·Status: COMPLETED ·Phase: PHASE2
-
Trial of Decitabine in Patients With Acute Myeloid Leukemia
NCT00260832 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized Study of Epigenetic Priming Using Decitabine With Front Line Induction Chemotherapy Compared With Immediate Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
NCT00943553 ·Status: WITHDRAWN ·Phase: PHASE2
-
Efficacy of Decitabine in Clearance of MRD
NCT03021395 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Omacetaxine and Decitabine in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)
NCT02141477 ·Status: TERMINATED ·Phase: PHASE1
-
Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT02029417 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
NCT06401603 ·Status: RECRUITING ·Phase: PHASE1
-
Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Chronic Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
NCT00042016 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
NCT01177540 ·Status: TERMINATED ·Phase: PHASE2
-
Decitabine, Cytarabine, GCSF for Refractory AML/MDS
NCT00740181 ·Status: TERMINATED ·Phase: PHASE2
-
Phase II Study of Decitabine and Cytarabine for Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
NCT01829503 ·Status: COMPLETED ·Phase: PHASE2
-
Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia
NCT01794702 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
DEC-205/NY-ESO-1 Fusion Protein CDX-1401and Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
NCT01834248 ·Status: COMPLETED ·Phase: PHASE1
-
Multi-Ctr PII Cmb.Modality Tx Ruxolitinib, Decitabine, and DLI for Post HSCT in AML/MDS
NCT04055844 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
NCT01378416 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Blast Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
NCT00042003 ·Status: COMPLETED ·Phase: PHASE2
-
Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia
NCT02890329 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia
NCT02996474 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT00861874 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
NCT02632721 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Decitabine in Treating Patients With Myelodysplastic Syndrome
NCT00003361 ·Status: COMPLETED ·Phase: PHASE2
-
Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT00814164 ·Status: TERMINATED ·Phase: PHASE2
-
Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia
NCT03063203 ·Status: TERMINATED ·Phase: PHASE2
-
Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
NCT01687400 ·Status: COMPLETED ·Phase: PHASE2