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NCT03904251 · ClinicalTrials.gov registry record · Phase 1
CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia
A Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT03904251: Clinical Trial Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
NCT03904251 is a Phase 1 study that was terminated before completion, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03904251, a Phase 1 study, was terminated before completion, sponsored by Jonsson Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This phase Ib trial studies the best dose of gemtuzumab ozogamicin when given together with CPX-351 in treating patients with acute myeloid leukemia that has come back after it was previously in remission. CPX-351 is a chemotherapy, which works in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to chemotherapy called calicheamicin. Gemtuzumab attaches to CD33 (transmembrane receptor) positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving CPX-351 and gemtuzumab ozogamicin may work better in treating patients with acute myeloid leukemia, compared to giving only one of these therapies alone.
Primary Outcome
MTD is defined as the cohort of participants one cohort below the cohort that develop dose-limiting toxicity (DLT) in at least 2 participants.
Interventions
- DRUG Gemtuzumab Ozogamicin
- DRUG Liposome-encapsulated Daunorubicin-Cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-07-18 |
| Est. Completion | 2023-10-25 |
| Phase | Phase 1 |
Why NCT03904251 stopped before completion
NCT03904251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemtuzumab Ozogamicin is the first listed.
NCT03904251 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03904251 about?
NCT03904251 is a clinical study titled "CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia". This phase Ib trial studies the best dose of gemtuzumab ozogamicin when given together with CPX-351 in treating patients with acute myeloid leukemia that has come back after it was previously in remission. CPX-351 is a chemotherapy, which works in different ways to stop the growth of cancer cells, e...
What is the current status of trial NCT03904251?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2019-07-18. Estimated completion is 2023-10-25.
What interventions are being tested in trial NCT03904251?
The interventions under investigation include: Gemtuzumab Ozogamicin (DRUG), Liposome-encapsulated Daunorubicin-Cytarabine (DRUG).
Who is sponsoring clinical trial NCT03904251?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03904251's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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