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A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
This study has been completed.
Sponsor:
Kanisa Pharmaceuticals
Information provided by:
Kanisa Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00233909
First received: October 4, 2005
Last updated: March 28, 2008
Last verified: March 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Leukemia, Myeloid | Drug: Zosuquidar Drug: gemtuzumab ozogamicin | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Phase I/II Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
core binding factor acute myeloid leukemia
cytogenetically normal acute myeloid leukemia
familial acute myeloid leukemia with mutated CEBPA
Genetic and Rare Diseases Information Center resources:
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Non Lymphoblastic Leukemia
U.S. FDA Resources
Further study details as provided by Kanisa Pharmaceuticals:
| Estimated Enrollment: | 55 |
| Study Start Date: | October 2005 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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)
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Morphologic evidence of acute myeloid leukemia in first relapse.
- Phase I: 18 years or older, Phase II: 50 years or older
Exclusion Criteria:
- Prior treatment with zosuquidar
- Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents
- History of stem cell transplant
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
No Contacts or Locations Provided
More Information
| ClinicalTrials.gov Identifier: | NCT00233909 History of Changes |
| Other Study ID Numbers: |
KAN-979-02 |
| Study First Received: | October 4, 2005 |
| Last Updated: | March 28, 2008 |
Keywords provided by Kanisa Pharmaceuticals:
|
Leukemia, Myeloid Relapse Chemotherapy Zosuquidar gemtuzumab ozogamicin (GO) |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type |
Neoplasms Gemtuzumab Antineoplastic Agents |
ClinicalTrials.gov processed this record on August 16, 2017