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CompletedNCT00037583Updated Aug 21, 2009

Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia

A Phase 2 interventional study of Gemtuzumab Ozogamicin in Acute Myeloid Leukemia, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2009-08-21.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
69
Ages
18 Years to 59 Years
Sex
All
01

Study summary

The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.

02

Conditions studied

  • Acute Myeloid Leukemia

Keywords

  • Acute
  • Myeloid
  • Leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 69 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study
  • Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study
  • Phase II will only allow enrollment of younger de novo AML

Exclusion criteria

Exclusion Criteria:

  • AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration
  • De novo patients with M3 AML
  • AML secondary to exposure to chemotherapy or radiation
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Enrollment
69 participants (actual)

Interventions

  • DrugGemtuzumab Ozogamicin
06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Hibma J, Knight B. Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia. Clin Pharmacokinet. 2019 Mar;58(3):335-347. doi: 10.1007/s40262-018-0699-5. PubMed 30062662 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00037583
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
May 20, 2002
Primary completion
Sep 2003
Completion
Sep 2003
Last update
Aug 21, 2009
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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