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NCT02311998 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT02311998: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT02311998 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02311998, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of bosutinib when given together with inotuzumab ozogamicin and to see how well it works in treating patients with acute lymphoblastic leukemia or chronic myeloid leukemia that has come back or does not respond to treatment. Bosutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells. Giving bosutinib together with inotuzumab ozogamicin may be a better treatment for acute lymphoblastic leukemia or chronic myeloid leukemia.
Primary Outcome
Maximum tolerated dose of bosutinib defined as the highest dose level in which \< 2 patients of 6 develop first course dose limiting toxicity (Phase I). Dose levels assessed were dose 1 = 300 mg, dose 2 = 400 mg, and dose 3 = 500 mg.
Interventions
- DRUG Bosutinib
- BIOLOGICAL Inotuzumab Ozogamicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2015-04-16 |
| Est. Completion | 2022-03-23 |
| Phase | Phase 1 |
What the finished NCT02311998 record still lists
NCT02311998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Bosutinib is the first listed.
NCT02311998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02311998 about?
NCT02311998 is a clinical study titled "Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML". This phase I/II trial studies the side effects and best dose of bosutinib when given together with inotuzumab ozogamicin and to see how well it works in treating patients with acute lymphoblastic leukemia or chronic myeloid leukemia that has come back or does not respond to treatment. Bosutinib may ...
What is the current status of trial NCT02311998?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2015-04-16. Estimated completion is 2022-03-23.
What interventions are being tested in trial NCT02311998?
The interventions under investigation include: Bosutinib (DRUG), Inotuzumab Ozogamicin (BIOLOGICAL).
Who is sponsoring clinical trial NCT02311998?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02311998's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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