Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia

NCT03104491 · View on ClinicalTrials.gov ↗

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

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

Sponsor

Leland Metheny

3 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Leland Metheny, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03104491 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Ohio, Kansas, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03104491?

The interventions under investigation include: Inotuzumab Ozogamicin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03104491?

This trial is sponsored by Leland Metheny, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial