NCT00037583

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

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

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
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
Last Updated

August 21, 2009

Status Verified

August 1, 2009

First QC Date

May 17, 2002

Last Update Submit

August 20, 2009

Conditions

Acute Myeloid Leukemia

Keywords

AcuteMyeloidLeukemia

Interventions

Gemtuzumab OzogamicinDRUG

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

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, AcuteLeukemia

Interventions

Gemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

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

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

August 21, 2009

Record last verified: 2009-08