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NCT03104491 · ClinicalTrials.gov registry record · Phase 1
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
A Phase 1 study of Acute Lymphocytic Leukemia, sponsored by Leland Metheny.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 7
- Study locations
NCT03104491 is a Phase 1 study of Acute Lymphocytic Leukemia that is actively recruiting participants, run by Leland Metheny. The registered enrollment target is 44 participants, below the 127-participant average among 24 other Acute Lymphocytic Leukemia trials with a reported enrollment target (65% lower). The trial reports 7 study locations across 5 states.
The verdict
NCT03104491, a Phase 1 study of Acute Lymphocytic Leukemia, is actively recruiting participants, sponsored by Leland Metheny.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 7
- Study locations
Study Summary
This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects. The Phase II portion of this study is to see what side effects are seen with medication after transplant. Inotuzumab ozogamicin is a combination of an antibody and chemotherapy which has been shown to have significant activity against relapsed/refractory acute lymphocytic leukemia (ALL). Inotuzumab ozogamicin is considered experimental in this study.
Conditions Studied
Interventions
- DRUG Inotuzumab Ozogamicin
Study Locations (7)
Ohio
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center - Cleveland
- The James Cancer Hospital and Solove Research Institute - Columbus
Kansas
- The University of Kansas Cancer Center - Westwood
Massachusetts
- Dana-Farber Cancer Institute - Boston
Nebraska
- University of Nebraska Medical Center - Omaha
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2017-07-31 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03104491
The ClinicalTrials.gov registry entry for NCT03104491 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 127-participant average among 24 other Acute Lymphocytic Leukemia trials with a reported enrollment target (65% lower). The listed sponsor is Leland Metheny, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Inotuzumab Ozogamicin is the first listed.
NCT03104491 reports 7 study locations spanning 5 distinct geographic areas - top geographies include Ohio, Kansas, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03104491 about?
NCT03104491 is a clinical study titled "Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia". This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects. The Phase II portion of this study is to see what side effect...
What is the current status of trial NCT03104491?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2017-07-31. Estimated completion is 2027-05.
What conditions does trial NCT03104491 study?
This clinical trial studies the following conditions: Acute Lymphocytic Leukemia.
What interventions are being tested in trial NCT03104491?
The interventions under investigation include: Inotuzumab Ozogamicin (DRUG).
Who is sponsoring clinical trial NCT03104491?
This trial is sponsored by Leland Metheny, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03104491 being conducted?
This trial has 7 study locations across Kansas, Massachusetts, Nebraska, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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