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Phase 2 Study Of AG-013736 In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)

Phase 2
18 Years
Not Enrolling
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome

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Trial Information

Phase 2 Study Of AG-013736 In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)

Inclusion Criteria:

- Poor prognosis AML or MDS

- Histological confirmation of diagnosis

- White blood cell count less than or equal to 30,000/mm3

- Adequate hepatic and renal function documented within 14 days prior to registration

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- No evidence of preexisting uncontrolled hypertension

- Not a suitable candidate for chemotherapy

- No prior systemic chemotherapy treatment for AML or MDS or treatment with an
anti-angiogenesis agent

Exclusion Criteria:

- Patients must not have exclusion criteria.

- Candidate for chemotherapy

- Patients with AML M3 (acute promyelocytic leukemia)

- Conditions that might confound the evaluation of safety or efficacy or increase
patient risk.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Objective Response (OR)

Outcome Description:

Participants with OR based on a assessment of confirmed complete remission (CR) or partial remission (PR) according to Cheson criteria for Acute myeloid leukemia (AML) and Myelodysplastic syndrome (MDS). CR: those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood value lasting at least 1 month and 2 months for AML and MDS respectively. PR : those with all criteria for CR except 5-25 % blasts in bone marrow and at least 50% decrease in blast over pretreatment for AML and MDS respectively.

Outcome Time Frame:

Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 4 weeks up to 35 weeks

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2003

Completion Date:

July 2004

Related Keywords:

  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndrome
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia



Pfizer Investigational Site Houston, Texas  77030