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NCT01564784 · ClinicalTrials.gov registry record · Phase 3
A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 326
- Enrollment target
NCT01564784: Completed Phase 3 study, sponsored by Pfizer.
NCT01564784 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 326 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01564784, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 326 participants
- Enrollment target
Study Summary
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
Primary Outcome
CR was the disappearance of leukemia indicated by less than (\<) 5 percent (%) marrow blasts \& absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) \& platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable \& non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all n
Interventions
- DRUG inotuzumab ozogamicin
- DRUG FLAG (fludarabine, cytarabine and G-CSF)
- DRUG HIDAC (high dose cytarabine)
- DRUG cytarabine and mitoxantrone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2012-08-02 |
| Est. Completion | 2017-01-04 |
| Phase | Phase 3 |
What the finished NCT01564784 record still lists
NCT01564784 is an interventional study that assigns participants to a tested intervention. The registered 326 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 (58% lower).
The record links to 0 conditions, and to 4 interventions - of which inotuzumab ozogamicin is the first listed.
NCT01564784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01564784 about?
NCT01564784 is a clinical study titled "A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia". This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
What is the current status of trial NCT01564784?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2012-08-02. Estimated completion is 2017-01-04.
What interventions are being tested in trial NCT01564784?
The interventions under investigation include: inotuzumab ozogamicin (DRUG), FLAG (fludarabine, cytarabine and G-CSF) (DRUG), HIDAC (high dose cytarabine) (DRUG), cytarabine and mitoxantrone (DRUG).
Who is sponsoring clinical trial NCT01564784?
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 NCT01564784's enrollment target sits among peer trials
326 1075th of 2000 higher than 925 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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