Home
Clinical Trials
Study Evaluating the Safety a...

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

Last Updated: 2009-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2003-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

NCT00037596

Acute Myeloid Leukemia

COMPLETED PHASE2

Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm

NCT03531918

Acute Myeloid Leukemia

COMPLETED PHASE1/PHASE2

Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome

NCT03672539

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia High Risk Myelodysplastic Syndrome +3 more

ACTIVE_NOT_RECRUITING PHASE2

Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

NCT00006122

Leukemia

COMPLETED PHASE2

Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy

NCT00070174

Leukemia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myeloid Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gemtuzumab Ozogamicin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers