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


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

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


Inclusion Criteria:



- 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);

- 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.

Exclusion Criteria:

- 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.

- 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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

duration of study

Safety Issue:

Yes

Principal Investigator

Joseph Scandura, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Institutional Review Board

Study ID:

0704009108

NCT ID:

NCT00538876

Start Date:

July 2007

Completion Date:

December 2009

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021