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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: Completed Phase 1 study, sponsored by Medical College of Wisconsin.
NCT03441048 is a Phase 1 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Dose-escalation will be conducted according to a 3+3 design with a five-patient expansion cohort at the recommended phase 2 dose. The initial dose of Lintuzumab-Ac225 will be 0.25 micro-Curie (μCi)/kg (Dose level 1), and the highest dose administered will be 1.25 μCi/kg. * if 0/3 pts have no dose-limiting toxicity (DLT), new patients enter next dose level. * if 1/3 pts has DLT, 3 pts treated at same dose level. * if 0/3 pts at that dose level has DLT, new pts enter higher level. * if 1 or more
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 |
What the finished NCT03441048 record still lists
NCT03441048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 5 interventions - of which Cladribine is the first listed.
NCT03441048 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03441048's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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