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NCT04681105 · ClinicalTrials.gov registry record · Phase 1
Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT04681105: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT04681105 is a Phase 1 study that has completed, run by City of Hope Medical 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
NCT04681105, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This phase I trial studies the best dose and side effects of flotetuzumab for the treatment of patients with blood cancers (hematological malignancies) that have spread to other places in the body (advanced) and have come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Flotetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
Primary Outcome
Toxicity will be graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events version 5.0 except infusion-related reaction (IRR)/cytokine release syndrome (CRS) which will be by the modified criteria proposed by Lee et al. Safety and toxicity will be assessed for each cohort independently. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, attribution, time of onset, duration, probable associat
Interventions
- DRUG Acetaminophen
- DRUG Ibuprofen
- DRUG Dexamethasone
- DRUG Diphenhydramine
- BIOLOGICAL Flotetuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-11-18 |
| Est. Completion | 2025-08-05 |
| Phase | Phase 1 |
What the finished NCT04681105 record still lists
NCT04681105 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 5 interventions - of which Acetaminophen is the first listed.
NCT04681105 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04681105 about?
NCT04681105 is a clinical study titled "Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies". This phase I trial studies the best dose and side effects of flotetuzumab for the treatment of patients with blood cancers (hematological malignancies) that have spread to other places in the body (advanced) and have come back after a period of improvement (relapsed) or does not respond to treatment...
What is the current status of trial NCT04681105?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2020-11-18. Estimated completion is 2025-08-05.
What interventions are being tested in trial NCT04681105?
The interventions under investigation include: Acetaminophen (DRUG), Ibuprofen (DRUG), Dexamethasone (DRUG), Diphenhydramine (DRUG), Flotetuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04681105?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04681105'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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