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NCT04337138 · ClinicalTrials.gov registry record
A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World
A clinical trial of Leukemia, Myeloid, Acute, sponsored by Pfizer.
- Completed
- Registry status
- 32
- Enrollment target
- 1
- Study location
NCT04337138: Completed study of Leukemia, Myeloid, Acute, sponsored by Pfizer.
NCT04337138 is a study of Leukemia, Myeloid, Acute that has completed, run by Pfizer. The registered enrollment target is 32 participants, below the 115-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04337138, a study of Leukemia, Myeloid, Acute, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this observational study is to describe treatment patterns and effectiveness outcomes in a sample of oncology patients treated for AML with Mylotarg through up to two additional relapsed/refractory (R/R)-based lines of therapy (through third-line therapy). The study will use United States oncology electronic medical record (EMR) data. All study data are secondary data and will have been collected retrospectively from existing clinical data originally collected as part of routine care.
Primary Outcome
rwEFS defined as time from treatment initiation date (for first line of Mylotarg-containing therapy) to date of treatment failure (TF), relapse from complete response (CR) or better, death from any cause, whichever came first. TF defined as failure to achieve CR or better following up to 3 cycles of Mylotarg. Time origin for rwEFS was start of Mylotarg in first line of therapy in which it was used. Terminal event for analysis of rwEFS was earlier of treatment failure, relapse from CR or better,
Conditions Studied
Interventions
- DRUG Gemtuzumab Ozogamicin
Study Locations (1)
New York
- Pfizer Investigational Site - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-04-07 |
| Est. Completion | 2020-07-31 |
What the finished NCT04337138 record still lists
NCT04337138 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 115-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Leukemia, Myeloid, Acute appearing as the primary indexed condition, and to 1 intervention - of which Gemtuzumab Ozogamicin is the first listed.
NCT04337138 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04337138 about?
NCT04337138 is a clinical study titled "A Study Of Treatment Patterns And Clinical Outcomes In Patients Diagnosed With Acute Myeloid Leukemia Who Received Mylotarg in the Real-World". The aim of this observational study is to describe treatment patterns and effectiveness outcomes in a sample of oncology patients treated for AML with Mylotarg through up to two additional relapsed/refractory (R/R)-based lines of therapy (through third-line therapy). The study will use United States...
What is the current status of trial NCT04337138?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2020-04-07. Estimated completion is 2020-07-31.
What conditions does trial NCT04337138 study?
This clinical trial studies the following conditions: Leukemia, Myeloid, Acute.
What interventions are being tested in trial NCT04337138?
The interventions under investigation include: Gemtuzumab Ozogamicin (DRUG).
Who is sponsoring clinical trial NCT04337138?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04337138 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04337138's enrollment target sits among peer trials
32 22nd of 30 higher than 9 of 30 other Leukemia, Myeloid, Acute trials
participants (enrollment target), bucketed by value
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