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NCT03878927 · ClinicalTrials.gov registry record · Phase 1
CPX-351+GO in Subjects 55 Years Old, or Older, With AML
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03878927 is a Phase 1 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 11 participants.
The verdict
NCT03878927, a Phase 1 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is an open label study to assess the safety and efficacy of CPX-351 in combination with gemtuzumab ozogamicin (GO) as first intensive therapy in older (age \>55 years) subjects with newly diagnosed AML who are eligible for intensive induction chemotherapy, or AML subjects who previously failed low-intensity therapy but who would be eligible for high-intensity chemotherapy, with companion cognitive function testing to determine whether this contributes to outcome in these subjects. Subjects may have received prior AML treatment with non-intensive regimens, e.g. hypomethylating agents, low-dose cytarabine, or lenalidomide or a clinical trial drug in combination with hypomethylating agents or low-dose cytarabine, but may not have received intensive AML treatment with anthracyclines and/or infusional cytarabine prior to enrollment on this trial. Subjects may not have been treated with GO or other antibody targeting CD 33 prior to enrollment on this trial. The cohort will include 30 subjects treated with the combination of CPX-351 and GO and is designed to establish the safety and feasibility of the combination. These subjects will be assessed for efficacy and safety. Quality of life will be assessed using the FACT-LEU in all subjects. Cognitive function will be assessed using the Blessed Orientation-Memory-Concentration Test and the Montreal Cognitive Assessment.
Interventions
- DRUG Gemtuzumab Ozogamicin
- DRUG CPX-351
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-08-23 |
| Est. Completion | 2022-09-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03878927
The ClinicalTrials.gov registry entry for NCT03878927 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Gemtuzumab Ozogamicin is the first listed.
NCT03878927 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03878927 about?
NCT03878927 is a clinical study titled "CPX-351+GO in Subjects 55 Years Old, or Older, With AML". This is an open label study to assess the safety and efficacy of CPX-351 in combination with gemtuzumab ozogamicin (GO) as first intensive therapy in older (age \>55 years) subjects with newly diagnosed AML who are eligible for intensive induction chemotherapy, or AML subjects who previously failed ...
What is the current status of trial NCT03878927?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2019-08-23. Estimated completion is 2022-09-01.
What interventions are being tested in trial NCT03878927?
The interventions under investigation include: Gemtuzumab Ozogamicin (DRUG), CPX-351 (DRUG).
Who is sponsoring clinical trial NCT03878927?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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