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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.

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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

FieldValue
Enrollment Target 44 participants
Start Date 2017-07-31
Est. Completion 2027-05
Phase Phase 1
Leland Metheny

3 total trials

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.

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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03104491, the US trial registry maintained by the National Library of Medicine. NCT03104491 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.