Study on Inotuzumab Ozogamicin and Blinatumomab for Treating CD22-Positive B-Lineage Acute Lymphoblastic Leukemia

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03739814

Provider View

This clinical trial is testing two drugs, inotuzumab ozogamicin and blinatumomab, to see how well they work in treating patients with a type of leukemia called CD22-positive B-lineage acute lymphoblastic leukemia. The study includes patients who are newly diagnosed, have had a recurrence, or whose cancer has not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of two drugs, inotuzumab ozogamicin and blinatumomab, in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia (ALL). These drugs are a type of immunotherapy that may help the immune system attack cancer cells and prevent them from growing and spreading. The study includes patients who are newly diagnosed, have had a recurrence, or whose cancer has not responded to previous treatments.

Description

This study is divided into two groups of patients:

  • Cohort 1: Patients who are older and cannot undergo a transplant. They will receive inotuzumab ozogamicin first, followed by blinatumomab. The study aims to see if this treatment can help them live longer without the cancer returning.
  • Cohort 2: Patients whose cancer has come back or has not responded to previous treatments. They will also receive inotuzumab ozogamicin followed by blinatumomab to see if this combination can help control their cancer.

The study will also look at how safe and tolerable the treatment is, and how it affects patients' overall survival and quality of life. Researchers will monitor patients for side effects and track their progress over time.

Patients will receive the treatment in several courses, with each course involving specific doses of the drugs given over a set period. After completing the treatment, patients will have regular follow-up visits to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of CD22-positive B-lineage acute lymphoblastic leukemia (ALL).
  • Must be Philadelphia chromosome/BCR-ABL1-negative.
  • No active central nervous system (CNS) leukemia.
  • Must not be pregnant or nursing.
  • Must have a good performance status (ECOG 0-2).
  • Must not have unstable heart disease or impaired heart function.
  • Must not have a history of significant neurological disorders.
  • Must not have other active cancers, except for certain skin cancers or cancers in remission for at least 2 years.
  • Must not have uncontrolled infections or recent serious infections.
  • Must meet specific blood and organ function criteria.
  • Cohort 1: Must be 60 years or older and have not received prior treatment for ALL, except for certain allowed therapies.
  • Cohort 2: Must be 18 years or older with relapsed or refractory disease, and have completed any prior treatments for ALL at least 14 days before starting the study treatment.

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