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A Phase I Study Using Bortezomib (Velcade, Formerly Known as PS-341) With Weekly Idarubicin for the Treatment of Elderly (>/= 60 Years) and Relapsed Patients With Acute Myelogenous Leukemia

Phase 1
18 Years
Not Enrolling
Acute Myelogenous Leukemia

Thank you

Trial Information

A Phase I Study Using Bortezomib (Velcade, Formerly Known as PS-341) With Weekly Idarubicin for the Treatment of Elderly (>/= 60 Years) and Relapsed Patients With Acute Myelogenous Leukemia

Inclusion Criteria:

- Age: > 60 years of age for newly diagnosed/transformed disease; > 18 years of age for
relapsed disease.

- AML with or without antecedent hematologic disorder diagnosed by morphologic,
histochemical, or cell surface marker criteria - as defined by the WHO classification

- Newly diagnosed, elderly patients who are considered unsuitable for intensive
chemotherapy induction -- antecedent hematologic disorders, pre-existing
myelodysplasia, trilineage dyspoiesis, unfavorable cytogenetics, or pre-existing

- Untreated conditions meeting criteria the first and third criteria or patients with
diagnosis as in criteria 2 who have relapsed after at least one successful induction
therapy. (Relapsed patients treated on this protocol will be patients without a
suitable donor for transplant or for whom transplant is not an option for other

- Karnofsky performance status >60.

- Adequate cardiac function as evidenced by an ejection fraction on MUGA >/= 40, as
well as no evidence of uncontrolled hypertension, New York Heart Class III/IV
congestive heart failure, angina pectoris, or ventricular dysrhythmias.

- Adequate renal function as evidenced by a calculated creatinine clearance >/=
30ml/min (Cockcroft-Gault formula).

- Adequate pulmonary function as evidenced by room air and exercise saturations >/= 92
or DLCO >/= 40% or FEV1 >/= 60% of predicted.

- Adequate liver function as evidenced by SGOT/SGPT less than 5 times the ULN and total
Bilirubin less than 2 times the ULN except where abnormalities are directly
attributable to leukemia.

- Adequate neurologic function -- patients must be currently free of active CNS
leukemia as evidenced by cytospin of CSF from lumbar puncture if there is any
clinical suspicion for CNS leukemia. As well, patients must not have >/= grade 2
neuropathy by NCI common toxicity criteria (CTC), Version 3.0.

- Prior anthracycline dose in relapsed patients must not exceed 72 mg/m^2 of idarubicin
or any dose equivalent to 300 mg/m^2 of adriamycin.

- Patients must be informed and sign a written consent.

Exclusion Criteria:

- Patients with acute promyelocytic leukemia. Patients with uncontrolled systemic

- Patients who are known to be HIV seropositive.

- Patients with evidence of CNS leukemia.

- Patients who are pregnant or lactating.

- Patients with primarily refractory disease unresponsive to a standard induction

- Patients with a new diagnosis as per inclusion criteria 2, but for whom standard
induction chemotherapy would be expected to be well tolerated and a preferred option
in the opinion of the principal investigator.

- Patients with relapsed AML, but for whom a suitable donor of stem cells exists and in
whom high-dose chemotherapy with hematopoietic stem cell transplant is felt to be a
better immediate alternative.

- Patients with any clinically significant abnormality in screening blood chemistry,
hematology or urinalysis results that, in the judgment of the investigator, would
impede adequate evaluation of adverse events and/or response to treatment, or that
requires aggressive intervention.

- Patients with hypersensitivity to Bortezomib, boron, or mannitol.

Type of Study:


Study Design:

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

Outcome Measure:

Maximum tolerated dose of bortezomib & idarubicin given in combination, with idarubicin given once weekly for 4 consecutive weeks & bortezomib given twice weekly over the same time.

Outcome Time Frame:

week 4

Safety Issue:


Principal Investigator

Dianna Howard, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kentucky


United States: Institutional Review Board

Study ID:




Start Date:

February 2004

Completion Date:

October 2008

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Myelogenous Leukemia
  • AML
  • Relapse
  • Elderly
  • Velcade
  • Idarubicin
  • Bortezomib
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



University of Rochester Rochester, New York  14642
University of Kentucky Lexington, Kentucky  40536-0098