Decitabine and Cedazuridine for Refractory Acute Myelogenous Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Refractory Acute Myelogenous Leukemia+3 MoreDecitabine and Cedazuridine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a combination of drugs as a possible treatment for acute myeloid leukemia.

Eligible Conditions
  • Refractory Acute Myelogenous Leukemia
  • Biphenotypic Acute Refractory Leukemia
  • Acute Recurrent Myeloid Leukemia
  • Biphenotypic Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Up to 2 years

Year 2
Duration of response
Year 2
Overall survival (OS)
Year 2
Event-free survival (EFS)
Up to 2 years
Gene expression profiles
Incidence of adverse events
Incidence of infectious complications
Number of patients who transition towards stem cell transplantation
Proportion of achieving HI
Day 28
Overall response rate (ORR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (decitabine and cedazuridine, venetoclax)
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Decitabine and Cedazuridine · No Placebo Group · Phase 2

Treatment (decitabine and cedazuridine, venetoclax)Experimental Group · 2 Interventions: Decitabine and Cedazuridine, Venetoclax · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,359 Total Patients Enrolled
Marina KonoplevaPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
413 Total Patients Enrolled
Abhishek MaitiPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient's Eastern Cooperative Oncology Group (ECOG) performance status is less than or equal to 2.
The enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are usually found at levels that are three times the upper limit of normal (ULN) in the blood
Creatinine levels will be less than 2 unless they are related to the disease.
The following shows that the direct bilirubin is less than 2 times the upper limit of normal (ULN) unless it is increased due to Gilbert's disease or leukemic involvement.
Male subjects must agree not to have unprotected sex and to not donate sperm from the time they start taking the study drug until 90 days after the last dose of the study drug.
Patients with a diagnosis of relapsed or refractory AML (or biphenotypic or bilineage leukemia including a myeloid component)
Treatment with a cytotoxic or immunotherapy agent is allowed prior to study initiation, as needed, for clinical benefit and after discussion with the PI