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Phase II Evaluation of Gemtuzumab Ozogamicin in Combination With Cytarabine in Untreated Patients Above the Age of 60 Years With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome


Phase 2
60 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia, Myelodysplastic Syndrome

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Trial Information

Phase II Evaluation of Gemtuzumab Ozogamicin in Combination With Cytarabine in Untreated Patients Above the Age of 60 Years With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome


To evaluate the safety and efficacy of gemtuzumab ozogamicin in combination with cytarabine
in inducing complete remission in patients with AML and advanced MDS over the age of 60
years.

Patients eligible for treatment will receive the following:

Mylotarg at 6 mg/m2 on day 1 as a 2 hour intravenous infusion

Cytarabine at 100 mg/m2/day as a continuous intravenous infusion daily for 7 days


Inclusion Criteria:



- Histologic diagnosis of AML or advanced MDS

- No prior cytotoxic treatment for AML. (patients may have been treated with prior
biologic therapy) Patients with MDS or AML that has evolved from MDS, could have
received prior low-dose cytotoxic therapy (i.e. azacytidine or low-dose ara-C).

Exclusion Criteria:

- Uncontrolled or severe cardiovascular disease or pulmonary disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the safety and efficacy of gemtuzumab ozogamicin (Mylotarg) in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years.

Outcome Time Frame:

From entry until 30 days post treatment.

Safety Issue:

Yes

Principal Investigator

Eric Feldman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Food and Drug Administration

Study ID:

0403-762

NCT ID:

NCT00195000

Start Date:

May 2003

Completion Date:

February 2008

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Weill Medcial College of Cornell UniversityNew York, New York  10021