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Post-Transplant Drug Study for ALL

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Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia

  • Sex: Any
  • Age: Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: Phase I
  • Conditions Being Studied: Cancer - Leukemia

Study Purpose

The purpose of this study is to evaluate overall disease free survival post stem cell transplant. There are two phases of this study using a drug called inotuzumab ozogamicin. Inotuzumab ozogamicin is a combination of an antibody and chemotherapy which targets and delivers chemotherapy directly to residual cancer cells in acute lymphocytic leukemia (ALL). Phase I of this study aims to identify what doses of inotuzumab ozogamicin can safely be given to subjects post-stem cell transplant without having too many side effects. Phase II of this study aims to further identify what side effects are seen with inotuzumab ozogamicin post-transplant.

Who Can Participate

Participants must be between 16 and 75 years of age and diagnosed with CD22-positive ALL. Participants with these conditions who are expecting to have or who have recently received a stem cell transplant may be eligible to participate in this study.

Principal Investigator
Leland Metheny MD
Department/Division
Cancer (Bone Marrow Transplant)
  • UH IRB: 12-16-39C; 17-569
  • StudyID: CASE1916
  • ClinicalTrials.gov: NCT03104491
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