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AzTrials

Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesPhase 2NCT00492401

Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia

A Phase 2 study testing decitabine, laboratory biomarker analysis and pharmacological study in people with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Del(5q), run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
decitabine, laboratory biomarker analysis and pharmacological study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
May 2007to Oct 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 33Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Phase II Study of Decitabine in Acute Myeloid Leukemia

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the rate of complete remission (CR) in patients with previously untreated acute myeloid leukemia treated with decitabine.

SECONDARY OBJECTIVES:

  1. Determine the rate of overall survival at 1 year in patients treated with this drug.

II. Determine the overall response rate (CR, incomplete CR, and partial remission) in patients treated with this drug.

III. Correlate the biological activity of decitabine with clinical endpoints and maximum concentration of plasma decitabine.

IV. Correlate intracellular concentration of decitabine with global DNA methylation, other biological endpoints, and clinical response.

OUTLINE:

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.

Patients undergo bone marrow aspiration and blood sample collection periodically for pharmacological and correlative studies. Samples are analyzed for gene expression, methylation of gene promoters, fetal hemoglobin (HgF), DNMT1 protein expression, maximum concentration of plasma decitabine, and global DNA methylation. Samples are analyzed by RT-PCR, Bio-COBRA, matrix-assisted laser desorption ionization time-of-flight mass spectrometry, SDS-PAGE (polyacrylamide gel electrophoresis), immunoblotting, and LC-MS/MS.

After completion of study treatment, patients are followed for at least 30 days.

Being tested
decitabine, laboratory biomarker analysis, pharmacological study, high performance liquid chromatography, microarray analysis
Medical subject headings
Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • decitabineDrug

    Also called 5-aza-dCyd, 5AZA, DAC

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • high performance liquid chromatographyOther

    Also called HPLC

    Correlative studies

  • microarray analysisGenetic

    Also called gene expression profiling

    Correlative studies

  • RNA analysisGenetic

    Correlative studies

  • mass spectrometryOther

    Correlative studies

  • DNA methylation analysisGenetic

    Correlative studies

  • matrix-assisted laser desorption/ionization time of flight mass spectrometryOther

    Also called MALDI-TOF Mass Spectrometry

    Correlative studies

Study groups in NCT00492401
Study groupRoleWhat they receive
Treatment (chemotherapy)ExperimentalPatients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to 24 weeks

Secondary outcomes (4)

  1. Measurement of DNA Methylation in Peripheral Blood or Bone Marrow Cells

    Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.

    Measured: From baseline to up to day 28 of course 1

  2. Measurement of DNMT Protein in Peripheral Blood or Bone Marrow Cells

    Expression studies were conducted using quantitative RT PCR. Expression of DNMT were normalized to the internal control to the ABL and levels of miR-29 to RNA U44.

    Measured: Pre treatment

  3. Measurement of HbF in Peripheral Blood or Marrow Cells

    Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.

    Measured: From baseline to up to days 28 of course 2

  4. Measurement of Gene Expression in Peripheral Blood or Bone Marrow

    Standard paired statistical tests, parametric and nonparametric, will be used to baseline with treatment values. With data collected serially over time, repeated measures analysis of variance will be used to analyze data.

    Measured: From baseline to up to day 28 of course 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionDec 2010
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00492401
Sponsor's protocol ID
NCI-2009-00246
Other IDs
OSU 07017, N01CM62207
Status last verified
May 2016
First submitted
25 Jun 2007
Last updated
27 Jun 2016

Publications

  • 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.

    PubMed 20368434

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing decitabine, laboratory biomarker analysis and pharmacological study in people with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Del(5q), run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Complete Remission (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00492401, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2016.

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