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Acute Myeloid LeukemiaPhase 1NCT00538876

Phase I Epigenetic Priming Using Decitabine With Induction Chemotherapy in AML

A Phase 1 study testing decitabine in people with Acute Myeloid Leukemia, run by Weill Medical College of Cornell University 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 is an open label phase I study designed to explore the feasibility, safety and biologic activity of epigenetic priming with decitabine prior to standard cytarabine, daunorubicin induction chemotherapy in younger patients with less-than-favorable risk AML. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
decitabine
Type of treatment
Injection or infusion
How many people
30 participants
Where
1 siteUnited States
Study dates
Jul 2007to Dec 2009
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Patients must have histologically or cytologically confirmed diagnosis of Acute Myelogenous Leukemia (AML)
  • Patient is >18 and ≤ 60 years of age.
  • AML subgroup is associated with less-than-favorable risk as defined by:
  • The absence of good risk molecular features: t(8;21), inv(16), t(16;16), or t(15;17) translocations identified by FISH or standard metaphase karyotyping or evidence for the corresponding fusion transcripts, AML1-ETO, CBFβ-SMMHC, or PML-RARα, as identified by RT-PCR or suggested by the FAB M3 phenotype;
  • A history of an antecedent myelodysplastic syndrome;
  • A history of an antecedent Philadelphia-chromosome negative myeloproliferative disorder (e.g., polycythemia vera, essential thrombocythemia, primary myelofibrosis);
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  • Treatment-related AML believed secondary to prior cytotoxic chemotherapy for an unrelated disease.
  • Patient has adequate cardiac function as defined by:
  • An echocardiogram or MUGA scan demonstrating an ejection fraction within normal limits.
  • ECOG performance status > = 2.
  • Patient has adequate hepatic/renal function as defined by:
  • Total bilirubin ≤ 2 mg/dL. Patients with documented evidence of Gilbert's Syndrome resulting in elevated total bilirubin levels will be eligible, provided all other eligibility criteria are met.
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤1.5 x the ULN.
  • Creatinine ≤ 2 mg/dL (or a creatinine clearance >50 mL/min/1.73 m2, by direct measure).
  • Patient is not childbearing:
  • Female subjects must be surgically sterile, postmenopausal, or have a β-HCG indicating that they are not pregnant at the time screening is performed.
  • Female patients of childbearing potential must agree to take appropriate measures to ensure that they do not become pregnant while enrolled on protocol (i.e., within 2 months of administration of chemotherapy).
  • Male patients must agree to take appropriate measures to ensure that they do not father a child while enrolled on protocol (i.e., within 2 months following administration of chemotherapy).
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • AML with "good risk" molecular features: karyotype demonstrating the presence of t(8;21), inv(16), t(16;16), or t(15;17) translocations identified by FISH or standard metaphase karyotyping or evidence for the corresponding fusion transcripts, AML1-ETO, CBFβ-SMMHC, or PML-RARα, as identified by RT-PCR or suggested by the FAB M3 phenotype.
  • Patient has a history of chronic myelogenous leukemia or has molecular evidence of the t(9;22) translocation by FISH, metaphase karyotype or RT-PCR for the BCR-ABL fusion transcript.
  • Patient has received chemotherapy (other than hydroxyurea) or radiation within the 2 weeks prior to planned therapy on this study.
  • Patient has an active second malignancy.
  • Patient has a medical condition or illness considered by the Investigator to constitute an unwarranted high risk for investigational drug treatment.
  • Patient has an uncontrolled serious infection.
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  • Patient is pregnant or nursing an infant.
  • Patient has a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies.
  • Patient has an inability or unwillingness, in the opinion of the Investigator, to comply with the protocol requirements.
  • Patients with central nervous system (CNS) (or leptomeningeal) involvement by their AML may be considered for treatment at the Investigator's discretion and following discussion with the Medical Monitor, in order to allow for appropriate management.
  • Patient has circulating blast count > 50,000/μL (patients may be enrolled if circulating blast count is controlled by hydroxyurea and/or, if clinically indicated, by leukopheresis).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Medical College of Cornell University

    New York, New York, 10021

Other trials in United States

About this study

Official title: Phase I Study of Epigenetic Priming Using Decitabine With Induction Chemotherapy in Patients With Acute Myelogenous Leukemia (AML)

This is an open label phase I study designed to explore the feasibility, safety and biologic activity of epigenetic priming with decitabine prior to standard cytarabine, daunorubicin induction chemotherapy in younger patients with less-than-favorable risk AML.

Primary Objective: To find an appropriate dose level for decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML.

Read more

Secondary Objectives:

  1. To establish the safety and expected toxicities of decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML.
  2. To establish the optimal dose schedule of decitabine required to broadly demethylate cytosine residues in genomic regulatory regions.
  3. To investigate, in selected cases, the molecular and cellular consequences of decitabine-induced hypomethylation by a) establishing the extent and degree of hypomethylation at specific genomic loci required to reactivate the expression of repressed genes and by b) determining the effect of hypomethylation on the differentiation and/or apoptosis of leukemic blasts.
Being tested
decitabine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • decitabineDrug

    Decitabine will be administered by intravenous injection at a dose of 20 mg/m2/day as a daily 1hr infusion (Arm A) or by continuous infusion (Arm B) for 3, 5 or 7 days. On the day following the final dose of decitabine, standard "7+3" induction chemotherapy will begin.

What is being measured

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

  1. To establish the safety and expected toxicities of decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML

    Measured: duration of study

Timeline

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

  1. First posted3 Oct 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionDec 2009
  4. Study completionDec 2009

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00538876
Sponsor's protocol ID
0704009108
Status last verified
Jun 2011
First submitted
2 Oct 2007
Last updated
30 Jun 2011
Results posted
No

Publications

  • Scandura JM, Roboz GJ, Moh M, Morawa E, Brenet F, Bose JR, Villegas L, Gergis US, Mayer SA, Ippoliti CM, Curcio TJ, Ritchie EK, Feldman EJ. Phase 1 study of epigenetic priming with decitabine prior to standard induction chemotherapy for patients with AML. Blood. 2011 Aug 11;118(6):1472-80. doi: 10.1182/blood-2010-11-320093. Epub 2011 May 25.

    PubMed 21613261

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing decitabine in people with Acute Myeloid Leukemia, run by Weill Medical College of Cornell University 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 19 inclusion and 11 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 30 Jun 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To establish the safety and expected toxicities of decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML (time frame: duration of study). 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 NCT00538876, 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 30 Jun 2011.

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