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NCT03991884 · ClinicalTrials.gov registry record · Phase 1
Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia
A Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03991884: Completed Phase 1 study, sponsored by University of Washington.
NCT03991884 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03991884, a Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This phase I trial studies the best dose of inotuzumab ozogamicin in combination with chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin, work 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. Giving inotuzumab ozogamicin in combination with chemotherapy may kill more cancer cells than with chemotherapy alone in treating patients with recurrent or refractory B-cell acute lymphoblastic leukemia.
Primary Outcome
Will be defined as the highest dose of InO administered in which the incidence of dose limiting toxicities (DLTs) is \< 33%, assuming at least 6 patients have been treated at this dose. DLTs assessed by: * Non-hematologic toxicities \>= grade 3 evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 (except for febrile neutropenia/infection, unless felt to be a direct consequence of treatment-related toxicity \[e.g., intestinal
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Etoposide
- DRUG Vincristine
- DRUG Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-09-24 |
| Est. Completion | 2023-06-28 |
| Phase | Phase 1 |
What the finished NCT03991884 record still lists
NCT03991884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03991884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03991884 about?
NCT03991884 is a clinical study titled "Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia". This phase I trial studies the best dose of inotuzumab ozogamicin in combination with chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called i...
What is the current status of trial NCT03991884?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-09-24. Estimated completion is 2023-06-28.
What interventions are being tested in trial NCT03991884?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Etoposide (DRUG), Vincristine (DRUG), Prednisone (DRUG).
Who is sponsoring clinical trial NCT03991884?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03991884's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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