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NCT03150693 · ClinicalTrials.gov registry record · Phase 3
Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 303
- Enrollment target
NCT03150693: Recruiting Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT03150693 is a Phase 3 study that is actively recruiting participants, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 303 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03150693, a Phase 3 study, is actively recruiting participants, sponsored by Alliance for Clinical Trials in Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 303 participants
- Enrollment target
Study Summary
This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as \[intervention\], 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 with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.
Primary Outcome
The EFS distributions between the two arms will be compared using non-stratified log-rank tests. EFS curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model. with diagnostics test on proportional hazard assumptions first. The corresponding hazard ratio, 2- and 3-year EFS estimates will be assessed, and EFS medians along with their 95% confidence intervals for the two treatment arms.
Interventions
- DRUG Dexamethasone
- DRUG Cytarabine
- DRUG Allopurinol
- DRUG Daunorubicin Hydrochloride
- DRUG Vincristine Sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2017-09-20 |
| Est. Completion | 2027-08 |
| Phase | Phase 3 |
What NCT03150693 shows while recruiting
NCT03150693 is an interventional study that assigns participants to a tested intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 5 interventions - of which Dexamethasone is the first listed.
NCT03150693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03150693 about?
NCT03150693 is a clinical study titled "Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia". This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy dr...
What is the current status of trial NCT03150693?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 303 participants. The study started on 2017-09-20. Estimated completion is 2027-08.
What interventions are being tested in trial NCT03150693?
The interventions under investigation include: Dexamethasone (DRUG), Cytarabine (DRUG), Allopurinol (DRUG), Daunorubicin Hydrochloride (DRUG), Vincristine Sulfate (DRUG).
Who is sponsoring clinical trial NCT03150693?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03150693's enrollment target sits among peer trials
303 1119th of 2000 higher than 882 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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