Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia

NCT00492401 | Completed Phase 2 Results

• 3 other identifiers: NCI-2009-00246OSU 07017N01CM62207
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Rate of Complete Remission

  Per International Working Group criteria: Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including \<5% blasts in BM aspirate with marrow spicules and a count of \> 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC \> 1000/uL, platelet count \> 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia \<1000/uL or thrombocytopenia \<100,000/ul. Complete Remission Rate (CRm + CRi)

  Up to 24 weeks

Secondary Outcomes (4)

• Measurement of DNA Methylation in Peripheral Blood or Bone Marrow Cells

  From baseline to up to day 28 of course 1

• Measurement of DNMT Protein in Peripheral Blood or Bone Marrow Cells

  Pre treatment

• Measurement of HbF in Peripheral Blood or Marrow Cells

  From baseline to up to days 28 of course 2

• Measurement of Gene Expression in Peripheral Blood or Bone Marrow

  From baseline to up to day 28 of course 1

Study Arms (1)

Treatment (chemotherapy)

EXPERIMENTAL

Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: decitabine; Other: laboratory biomarker analysis; Other: pharmacological study; Other: high performance liquid chromatography; Genetic: microarray analysis; Genetic: RNA analysis; Other: mass spectrometry; Genetic: DNA methylation analysis; Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry

Interventions

decitabine DRUG

Given IV

Also known as: 5-aza-dCyd, 5AZA, DAC

Treatment (chemotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (chemotherapy)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (chemotherapy)

high performance liquid chromatography OTHER

Correlative studies

Also known as: HPLC

Treatment (chemotherapy)

microarray analysis GENETIC

Correlative studies

Also known as: gene expression profiling

Treatment (chemotherapy)

RNA analysis GENETIC

Correlative studies

Treatment (chemotherapy)

mass spectrometry OTHER

Correlative studies

Treatment (chemotherapy)

DNA methylation analysis GENETIC

Correlative studies

Treatment (chemotherapy)

matrix-assisted laser desorption/ionization time of flight mass spectrometry OTHER

Correlative studies

Also known as: MALDI-TOF Mass Spectrometry

Treatment (chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Blum W, Garzon R, Klisovic RB, Schwind S, Walker A, Geyer S, Liu S, Havelange V, Becker H, Schaaf L, Mickle J, Devine H, Kefauver C, Devine SM, Chan KK, Heerema NA, Bloomfield CD, Grever MR, Byrd JC, Villalona-Calero M, Croce CM, Marcucci G. Clinical response and miR-29b predictive significance in older AML patients treated with a 10-day schedule of decitabine. Proc Natl Acad Sci U S A. 2010 Apr 20;107(16):7473-8. doi: 10.1073/pnas.1002650107. Epub 2010 Apr 5.

  PMID: 20368434 DERIVED

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Decitabine; Chromatography, High Pressure Liquid; Microarray Analysis; Gene Expression Profiling; Mass Spectrometry; DNA Methylation

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Chromatography, Liquid; Chromatography; Chemistry Techniques, Analytical; Investigative Techniques; Microchip Analytical Procedures; Genetic Techniques; Methylation; Alkylation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Genetic Phenomena

Limitations and Caveats

After completing the target accrual of 33 subjects, the study was expanded to include 22 additional patients. All patients who received decitabine are included in the analyses, except for two who had not completed therapy at the time of the analysis.

Results Point of Contact

• Title: William Blum, MD
• Organization: The Ohio State University Comprehensive Cancer Center

William.Blum@osumc.edu

614-293-9273

Study Officials

• William Blum

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: October 1, 2014
• Last Updated: June 27, 2016
• Results First Posted: June 27, 2016

Record last verified: 2016-05

Locations

US (1)