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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    40
  • sponsor
    M.D. Anderson Cancer Center
Updated on 21 March 2022
cancer
remission
stem cell transplantation
lymphoid leukemia
tyrosine
philadelphia chromosome
flow cytometry
monoclonal antibodies
cell transplantation
leukemia
lymphocytic leukemia
minimal residual disease
b-cell acute lymphoblastic leukemia
residual tumor
kinase inhibitor
monoclonal antibody therapy
tyrosine kinase inhibitor
monoclonal protein
inotuzumab
salvage therapy

Summary

This phase II trial studies how well inotuzumab ozogamicin works in treating patients with B-cell acute lymphocytic leukemia with positive minimal residual disease. Inotuzumab ozogamicin is a monoclonal antibody called inotuzumab linked to a toxic agent called ozogamicin. Inotuzumab ozogamicin attaches to B cell-specific CD22 cancer cells in a targeted way and kills them.

Description

PRIMARY OBJECTIVE:

I. To evaluate the clinical efficacy of inotuzumab ozogamicin in patients B-cell acute lymphoblastic leukemia (ALL) in complete morphologic remission with positive minimal residual disease (MRD) in terms of relapse-free survival (RFS).

SECONDARY OBJECTIVE:

I. To evaluate other efficacy endpoints such as overall survival and MRD negativity rate by flow cytometry and/or polymerase chain reaction (PCR) overall and after the first cycle, as well as safety of inotuzumab ozogamicin in this setting.

OUTLINE

Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on days 1 and 8. Treatment repeats every 21-28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 day and then periodically every 6 months.

Details
Condition Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Recurrent B Acute Lymphoblastic Leukemia
Treatment Inotuzumab Ozogamicin
Clinical Study IdentifierNCT03441061
SponsorM.D. Anderson Cancer Center
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with B-lineage ALL in hematologic complete remission (CR) with molecular failure (i.e., had never achieved an MRD-negativity status before inotuzumab ozogamicin) or had a molecular relapse (i.e., 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 a value of at least of 10^-4 (0.01%) 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 Philadelphia chromosome (Ph)+ ALL can be enrolled in CR1 or CR2 and beyond. A tyrosine kinase inhibitor (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 a level of at least 1x10^-4 (0.01%) 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
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