RecruitingPhase 1Phase 2NCT03104491

Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia


Sponsor

Leland Metheny

Enrollment

44 participants

Start Date

Jul 31, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called inotuzumab ozogamicin — a targeted antibody therapy — given to patients after a stem cell (bone marrow) transplant for a type of blood cancer called acute lymphoblastic leukemia (ALL), to try to eliminate any remaining cancer cells and prevent relapse. **You may be eligible if...** - You have been diagnosed with CD22-positive ALL (a specific type of leukemia) - You have already received a stem cell transplant from a donor for your leukemia - You are between 40 and 100 days after your transplant - There are still detectable leukemia cells in your body (minimal residual disease) OR you were in second or third remission at the time of transplant - Your blood counts have recovered sufficiently after the transplant - You are able to function reasonably well in daily life (ECOG performance status under 2) - You are willing and able to sign an informed consent **You may NOT be eligible if...** - You are more than 100 days past your transplant - Your blood counts have not recovered enough - You have significant liver, kidney, or other organ problems - You have active graft-versus-host disease (a complication where donor cells attack your body) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInotuzumab 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)


Locations(7)

The University of Kansas Cancer Center

Westwood, Kansas, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT03104491


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