Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomized Study of Decitabine in Maintenance Therapy of Acute Myeloid Leukemia (AML)

NCT00398983

Acute Myelogenous Leukemia

COMPLETED PHASE2/PHASE3

Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients

NCT01149408

Acute Myeloid Leukemia AML

COMPLETED PHASE1

Trial of Decitabine in Patients With Acute Myeloid Leukemia

NCT00260832

Acute Myeloid Leukemia

COMPLETED PHASE3

Study of Decitabine in Combination With Sequential Rapamycin or Ribavirin in High Risk AML Patients

NCT02109744

Acute Myelogenous Leukemia

COMPLETED PHASE1/PHASE2

Phase I Epigenetic Priming Using Decitabine With Induction Chemotherapy in AML

NCT00538876

Acute Myeloid Leukemia

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myeloid Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

Decitabine

Intervention Type DRUG

20 mg/m\^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decitabine

20 mg/m\^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dacogen

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks of study enrollment.
2. Ineligible to receive intensive chemotherapy for their disease.
3. Have not received any chemotherapy within 4 weeks of study enrollment and must have recovered from any treatment-related toxicities.

Exclusion Criteria

1. Received previous treatment for AML.
2. Previously received Vidaza.
3. Received any other investigational agents within 30 days of first dose of study drug.
4. Uncontrolled intercurrent illness.
5. Had radiotherapy within 14 days prior to study enrollment.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No