Inotuzumab Ozogamicin in Treating Patients With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease

Launched by M.D. ANDERSON CANCER CENTER · Feb 15, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called inotuzumab ozogamicin for patients with a type of blood cancer known as B-cell acute lymphoblastic leukemia (ALL). Specifically, it focuses on patients who still have signs of the disease after previous treatment, known as minimal residual disease (MRD). Inotuzumab ozogamicin works by attaching to cancer cells and delivering a toxic agent that helps kill those cells. This trial is currently recruiting participants, and anyone between the ages of 65 and 74 years who has had difficulty achieving a clear status from their leukemia treatments may be eligible.

To participate, patients should have a form of B-cell ALL that has not fully responded to earlier therapies, and they must meet specific health criteria. For example, they should not have other serious health conditions that could interfere with the study. Participants can expect regular check-ups and monitoring while receiving the treatment, and they will be helping researchers understand how well this new therapy works in fighting their leukemia. It’s important to note that women who are pregnant or breastfeeding, and those with certain infections or active diseases, will not be able to join the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with B-lineage ALL in hematologic complete remission (CR) with molecular failure (ie, had never achieved an MRD-negativity status before inotuzumab ozogamicin) or had a molecular relapse (ie, became MRD positive after having been MRD negative) starting at any time point after 3 months of frontline therapy. Molecular disease or minimal residual disease is defined by any level of measurable residual disease identified by multicolor flow cytometry, PCR and/or next-generation sequencing (NGS).
• • Patients with B-lineage ALL in at least marrow CR in salvage 1 and beyond with MRD failure at any time point after 1 month of salvage therapy are allowed, including patients who received prior allogeneic stem cell transplantation.
• • Patients with Ph+ ALL can be enrolled in CR1 or CR2 and beyond. A TKI will be added at the discretion of the treating physician. MRD for these patients will be defined by either 1.) a ratio of BCR-ABL1 to ABL1 by PCR of ≥ 0.01% according to the International Scale for patients with p210 transcript or a ratio of BCR-ABL1 to ABL1 by PCR of ≥ 0.01% for patients with non-p210 transcripts, or 2.) detectable MRD at any level of measurable residual disease identified by multicolor flow cytometry and/or by NGS.
• • Performance status of 0, 1, or 2
• • Creatinine clearance \>= 15 ml/min
• • Bilirubin \< 1.5 X upper limit of normal (ULN)
• • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 X ULN
• • No active or co-existing malignancy with life expectancy less than 12 months
• Exclusion Criteria:
• • Pregnant or nursing women
• • Known to be human immunodeficiency virus positive (HIV+)
• • Active and uncontrolled disease/infection as judged by the treating physician
• • Unable or unwilling to sign the consent form
• • Active central nervous system (CNS) or extramedullary disease
• • Monoclonal antibodies therapy within 2 weeks before study entry
• • Radiotherapy or cancer chemotherapy (except for intrathecal prophylaxis and/or low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, steroids) or any investigational drug within 2 weeks before study entry