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NCT03677596 · ClinicalTrials.gov registry record · Phase 4
A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 102
- Enrollment target
NCT03677596: Completed Phase 4 study, sponsored by Pfizer.
NCT03677596 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 102 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03677596, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 102 participants
- Enrollment target
Study Summary
This study will explore 2 different doses of inotuzumab ozogamicin including the dose that is approved and a lower dose. The main purpose of this study is to evaluate whether a dose of inotuzumab ozogamicin, lower than the approved dose, could be recommended for adult patient with relapsed or refractory ALL who may be at higher risk for severe liver problems after inotuzumab ozogamicin treatment and stem cell transplant (a potentially curative therapy that can replace cancer cells with healthy cells). Efficacy and safety of the 2 doses will be evaluated.
Primary Outcome
VOD happened when the small blood vessels that lead into the liver and were inside the liver become blocked. VOD is defined as: a. Classical VOD (first 21 days after HSCT): Bilirubin\>=2 mg/dL and 2 (or more) of the following criteria must also be present: 1. Painful hepatomegaly; 2. Weight gain \>5%; 3. Ascites. b. Late onset VOD (\>21 days after HSCT): Classical VOD beyond Day 21; or Histologically proven VOD; or Two or more of the following criteria must be present: 1. Bilirubin \>2 mg/dL; 2.
Interventions
- DRUG inotuzumab ozogamicin-dose level 2
- DRUG Inotuzumab ozogamicin-dose level 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2023-05-26 |
| Phase | Phase 4 |
What the finished NCT03677596 record still lists
NCT03677596 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which inotuzumab ozogamicin-dose level 2 is the first listed.
NCT03677596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03677596 about?
NCT03677596 is a clinical study titled "A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients". This study will explore 2 different doses of inotuzumab ozogamicin including the dose that is approved and a lower dose. The main purpose of this study is to evaluate whether a dose of inotuzumab ozogamicin, lower than the approved dose, could be recommended for adult patient with relapsed or refrac...
What is the current status of trial NCT03677596?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2019-07-01. Estimated completion is 2023-05-26.
What interventions are being tested in trial NCT03677596?
The interventions under investigation include: inotuzumab ozogamicin-dose level 2 (DRUG), Inotuzumab ozogamicin-dose level 1 (DRUG).
Who is sponsoring clinical trial NCT03677596?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03677596's enrollment target sits among peer trials
102 764th of 2000 higher than 1,235 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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