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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: Recruiting Phase 1 study of Acute Lymphocytic Leukemia, sponsored by Leland Metheny.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined post hematopoietic stem cell transplantation MTD
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 |
What NCT03104491 shows while recruiting
NCT03104491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 127-participant average among 24 other Acute Lymphocytic Leukemia trials with a reported enrollment target (65% lower).
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 lists 7 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Acute Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03104491's enrollment target sits among peer trials
44 10th of 24 higher than 15 of 24 other Acute Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lymphocytic Leukemia 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.
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