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Trial record 1 of 1 for:    NCT03441061
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Inotuzumab Ozogamicin in Treating Participants With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease

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ClinicalTrials.gov Identifier: NCT03441061
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase II trial studies how well inotuzumab ozogamicin works in treating participants 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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Allogeneic Hematopoietic Stem Cell Transplantation Recipient B Acute Lymphoblastic Leukemia Minimal Residual Disease Philadelphia Chromosome Positive Recurrent B Acute Lymphoblastic Leukemia Biological: Inotuzumab Ozogamicin Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

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 OBJECTIVES:

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:

Participants receive inotuzumab ozogamicin intravenously (IV) over 1 hour on days 1, 8, and 15 of cycle 1 and days 1 and 8 of subsequent cycles. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Inotuzumab Ozogamicin in Patients With B-Cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2023


Arm Intervention/treatment
Experimental: Treatment (inotuzumab ozogamicin)
Participants receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15 of cycle 1 and days 1 and 8 of subsequent cycles. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Biological: Inotuzumab Ozogamicin
Given IV
Other Names:
  • Besponsa
  • CMC-544
  • Way 207294
  • WAY-207294




Primary Outcome Measures :
  1. Relapse-free survival (RFS) [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 4 years ]
    Will continuously monitor treatment-related toxicities using the Bayesian approach of Thall, Simon, Estey. For the purpose of toxicity monitoring, toxicities are defined as any treatment-related grade 3 or 4 non-hematologic adverse events occurring any time during the trial.

  2. Overall survival [ Time Frame: Up to 4 years ]
  3. Minimal residual disease (MRD) negativity rate [ Time Frame: Up to 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441061


Contacts
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Contact: Elias Jabbour, MD 713-792-4764 ejabbour@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Elias Jabbour    713-792-4764      
Principal Investigator: Elias Jabbour         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Elias Jabbour M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03441061     History of Changes
Other Study ID Numbers: 2015-0921
NCI-2018-00936 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-0921 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Philadelphia Chromosome
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Neoplastic Processes
Inotuzumab Ozogamicin
Antineoplastic Agents