NCT00037596

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2000

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2002

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

2.7 years

First QC Date

May 17, 2002

Last Update Submit

February 11, 2013

Conditions

Acute Myeloid Leukemia

Interventions

Gemtuzumab OzogamicinDRUG
cytarabine.DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Morphologic diagnosis of AML from bone marrow aspirate and biopsy
  • Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33+, based on local laboratory criteria
  • Age 18 years or older for relapsed or refractory patients for Phase I of this study

You may not qualify if:

  • Patients with de novo AML of the M3 subtype
  • AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of \> 2 months duration
  • AML secondary to exposure to chemotherapy or radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30062662DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

GemtuzumabCytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2002

First Posted

May 20, 2002

Study Start

August 1, 2000

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

February 13, 2013

Record last verified: 2013-02