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NCT03441048 · ClinicalTrials.gov registry record · Phase 1
Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03441048 is a Phase 1 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 26 participants.
The verdict
NCT03441048, a Phase 1 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is a prospective, single-center phase I clinical study aimed at determining the maximum-tolerated dose, recommended phase 2 dose and safety of Lintuzumab-Ac225 in combination with CLAG-M chemotherapy in the management of relapsed/refractory acute myeloid leukemia. This study uses a 3+3 design with a five-patient cohort at the recommended phase 2 dose.
Interventions
- DRUG Cladribine
- DRUG G-CSF
- DRUG Cytarabine
- DRUG Mitoxantrone
- BIOLOGICAL Lintuzumab-Ac-225
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-05-22 |
| Est. Completion | 2024-05-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03441048
The ClinicalTrials.gov registry entry for NCT03441048 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cladribine is the first listed.
NCT03441048 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03441048 about?
NCT03441048 is a clinical study titled "Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia". This is a prospective, single-center phase I clinical study aimed at determining the maximum-tolerated dose, recommended phase 2 dose and safety of Lintuzumab-Ac225 in combination with CLAG-M chemotherapy in the management of relapsed/refractory acute myeloid leukemia. This study uses a 3+3 design w...
What is the current status of trial NCT03441048?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2018-05-22. Estimated completion is 2024-05-22.
What interventions are being tested in trial NCT03441048?
The interventions under investigation include: Cladribine (DRUG), G-CSF (DRUG), Cytarabine (DRUG), Mitoxantrone (DRUG), Lintuzumab-Ac-225 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03441048?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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