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Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia

NCT03104491 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-06-05

No results posted yet for this 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

  • Acute Lymphocytic Leukemia

Interventions

DRUG

Inotuzumab Ozogamicin

Inotuzumab ozogamicin, IV, 28 day cycles Phase 1 dosages: Dose Level -2 (0.1 mg/m\^2) Dose Level -1 (0.2 mg/m\^2) Dose Level 0 (0.3 mg/m\^2) Dose Level 1 (0.4 mg/m\^2) Dose Level 2 (0.5 mg/m\^2) Dose Level 3 (0.6 mg/m\^2)

Sponsors & Collaborators

  • Leland Metheny

    lead OTHER

Principal Investigators

  • Leland Metheny, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2025-11-30
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03104491 on ClinicalTrials.gov