Phase 2 N=55 Treatment

Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities · Adult Acute Myeloid Leukemia With Del(5q) · Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) · Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) · Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)

Bottom Line

View on ClinicalTrials.gov: NCT00492401 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: Rate of Complete Remission — 25 patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: decitabine (Drug); laboratory biomarker analysis (Other); pharmacological study (Other); high performance liquid chromatography (Other); microarray analysis (Genetic); RNA analysis (Genetic); mass spectrometry (Other); DNA methylation analysis (Genetic); matrix-assisted laser desorption/ionization time of flight mass spectrometry (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Complete Remission	25	—
SECONDARY Measurement of DNA Methylation in Peripheral Blood or Bone Marrow Cells	—	—
SECONDARY Measurement of DNMT Protein in Peripheral Blood or Bone Marrow Cells	0.0056394; 0.0024305; 0.000196066; 0.000341819	.02 sig
SECONDARY Measurement of HbF in Peripheral Blood or Marrow Cells	—	—
SECONDARY Measurement of Gene Expression in Peripheral Blood or Bone Marrow	—	—

Summary

This phase II trial is studying how well decitabine works in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed acute myeloid leukemia (AML) meeting 1 of the following criteria:
At least 60 years of age and not a candidate for or refused standard induction treatment
Poor risk cytogenetics
AML following antecedent hematologic disorder
Therapy-related AML
Secondary AML
No granulocytic sarcoma as sole site of disease
No active CNS disease or CNS relapse
ECOG performance status 0-2
Life expectancy > 6 months
Total bilirubin < 2.0 mg/dL
Creatinine < 2.0 mg/dL
AST and ALT < 2.5 times upper limit of normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No NYHA class III or IV congestive heart failure
No uncontrolled infection
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine that are not easily managed
No other uncontrolled illness including, but not limited to, any of the following:
Symptomatic congestive heart failure
Unstable angina pectoris
Serious cardiac arrhythmia
Psychiatric illness or social situations that would preclude compliance with study requirements
No active second malignancy involving the blood or marrow or likely to progress and require therapy in the next 6 months
No prior therapy for AML except emergency leukapheresis or hydroxyurea for leukocytosis
No prior azacitidine or decitabine
No prior cytarabine or other conventional chemotherapy agents for antecedent hematologic disorders
Prior myeloid growth factors, recombinant erythropoietin, thalidomide, or lenalidomide allowed
No concurrent palliative radiotherapy
No other concurrent investigational agents
No other concurrent direct anti-leukemia therapy
No concurrent combination antiretroviral therapy for HIV-positive patients

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00492401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.