A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia

An Open-Label, Phase I/II Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00233909

Enrollment

Registered

2005-10-06

Start date

2005-10-31

Completion date

2008-03-31

Last updated

2008-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myeloid

Keywords

Leukemia, Myeloid, Relapse, Chemotherapy, Zosuquidar, gemtuzumab ozogamicin (GO)

Brief summary

Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO) is more effective with or without zosuquidar in treating acute myeloid leukemia.

Detailed description

Purpose: Phase I: Determine the optimal dose and schedule of GO and zosuquidar when used in combination. Phase II: Determine the complete remission rate (CR+CRp)

Interventions

DRUGZosuquidar

DRUGgemtuzumab ozogamicin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Morphologic evidence of acute myeloid leukemia in first relapse. 2. Phase I: 18 years or older, Phase II: 50 years or older

Exclusion criteria

1. Prior treatment with zosuquidar 2. Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents 3. History of stem cell transplant

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026