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NCT03531918 · ClinicalTrials.gov registry record · Phase 1
Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT03531918 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 66 participants.
The verdict
NCT03531918, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dosing frequency of gemtuzumab ozogamicin when given in combination with granulocyte colony stimulating factor (G-CSF), cladribine, cytarabine and mitoxantrone (GCLAM) and to see how well they work in treating participants with acute myeloid leukemia or high-grade myeloid tumors (neoplasms) that have not been previously treated. Antibody-drug conjugates, such as gemtuzumab ozogamicin, act by directly delivering toxic chemotherapy to cancer cells. Granulocyte colony stimulating factor is a growth factor used to stimulate leukemia cells and render them more sensitive to chemotherapy drugs. Drugs used in chemotherapy, such as cladribine, cytarabine and mitoxantrone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving gemtuzumab ozogamicin in combination with G-CSF, cladribine, cytarabine and mitoxantrone hydrochloride may work better in treating participants with acute myeloid leukemia or high-grade myeloid neoplasm.
Interventions
- DRUG Cladribine
- DRUG Gemtuzumab Ozogamicin
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Recombinant Granulocyte Colony-Stimulating Factor
- DRUG Cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2018-09-14 |
| Est. Completion | 2021-11-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03531918
The ClinicalTrials.gov registry entry for NCT03531918 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cladribine is the first listed.
NCT03531918 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03531918 about?
NCT03531918 is a clinical study titled "Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm". This phase I/II trial studies the side effects and best dosing frequency of gemtuzumab ozogamicin when given in combination with granulocyte colony stimulating factor (G-CSF), cladribine, cytarabine and mitoxantrone (GCLAM) and to see how well they work in treating participants with acute myeloid le...
What is the current status of trial NCT03531918?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2018-09-14. Estimated completion is 2021-11-01.
What interventions are being tested in trial NCT03531918?
The interventions under investigation include: Cladribine (DRUG), Gemtuzumab Ozogamicin (DRUG), Laboratory Biomarker Analysis (OTHER), Recombinant Granulocyte Colony-Stimulating Factor (BIOLOGICAL), Cytarabine (DRUG).
Who is sponsoring clinical trial NCT03531918?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
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