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NCT01363297 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT01363297: Completed Phase 2 study, sponsored by Pfizer.
NCT01363297 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01363297, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule. The Phase 2 portion of the study will evaluate the efficacy of inotuzumab ozogamicin as measured by hematologic remission rate (CR + CRi) in patients in second or later salvage status.
Primary Outcome
DLT was any of the following in the first cycle \& attributable to inotuzumab ozogamicin: any greater than or equal to (≥) Grade 4 non-hematologic toxicity except nausea/vomiting (if manageable with supportive care), alopecia, \& toxicities secondary to neutropenia \& sepsis; prolonged myelosuppression (absolute neutrophil count \[ANC\] less than \[\<\] 500 per microliter \[/µL\] or platelet count \<25,000/µL in bone marrow with \<5 percent (%) blasts \& no evidence of leukemia more than 45 days
Interventions
- DRUG Inotuzumab Ozogamicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
What the finished NCT01363297 record still lists
NCT01363297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 1 intervention - of which Inotuzumab Ozogamicin is the first listed.
NCT01363297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01363297 about?
NCT01363297 is a clinical study titled "Study Evaluating Inotuzumab Ozogamicin In Acute Lymphocytic Leukemia". The Phase 1 portion of this study will assess the safety, tolerability and efficacy at increasing dose levels of inotuzumab ozogamicin in subjects with CD22-positive relapsed or refractory adult acute lymphocytic leukemia (ALL) in order to select the recommended phase 2 dose (RP2D) and schedule. The...
What is the current status of trial NCT01363297?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2011-08. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01363297?
The interventions under investigation include: Inotuzumab Ozogamicin (DRUG).
Who is sponsoring clinical trial NCT01363297?
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 NCT01363297's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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