Study on Combining Inotuzumab Ozogamicin with Lower Dose Chemotherapy Versus Standard Chemotherapy for Adults with B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05303792

Provider View

This clinical trial is comparing a new treatment combination of inotuzumab ozogamicin and lower dose chemotherapy to the usual chemotherapy for adults with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. The goal is to see if the new combination can better shrink the cancer and prevent it from coming back.

Patient Parameters

Program Overview

This study is testing whether a combination of inotuzumab ozogamicin, a targeted therapy, with lower dose chemotherapy is more effective than the usual chemotherapy alone in treating adults with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin works by attaching to specific molecules on cancer cells and delivering a drug to kill them. The study aims to find out if this combination can help reduce the cancer and stop it from returning.

Description

The main goal of this study is to compare how well the new treatment combination works in keeping the cancer from coming back compared to the standard treatment. Researchers will look at how long patients remain free of cancer and how well they respond to the treatment.

Secondary goals include:

  • Checking the overall response rate to the treatments at different stages.
  • Measuring how many patients have no detectable cancer cells after treatment.
  • Comparing different methods of measuring cancer response and their outcomes.
  • Evaluating the safety and side effects of the treatments.
  • Understanding how the treatments affect patients' quality of life and any symptoms they report.

Participants will be randomly assigned to one of two groups:

Group A (New Treatment):

  • Receive a combination of inotuzumab ozogamicin and lower dose chemotherapy drugs in cycles.
  • Treatment cycles repeat every 28 days, with adjustments based on age and health.
  • After initial treatment, patients will continue with maintenance therapy for up to 2 years.

Group B (Standard Treatment):

  • Receive the usual chemotherapy drugs in cycles.
  • Treatment cycles repeat every 28 days, with adjustments based on age and health.
  • After initial treatment, patients will continue with maintenance therapy for up to 2 years.

After completing the study treatment, patients will have regular follow-up visits to monitor their health and any signs of cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Must provide a bone marrow or blood sample before starting the study.
  • Diagnosed with B-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) with at least 5% cancer cells in the bone marrow or blood.
  • Cancer cells must have the CD22 marker.
  • No prior chemotherapy for ALL, except for certain allowed treatments.
  • Age 50 years or older.
  • Good overall health with a performance status score of 2 or less.
  • Adequate kidney and liver function as indicated by specific blood tests.
  • No significant liver disease that would make the study unsafe.
  • Women and men of reproductive potential must agree to use effective birth control during the study.

Exclusion Criteria

  • Medical conditions that are not well-controlled, such as diabetes, heart disease, or lung disease.
  • Patients with HIV who are on effective treatment and have an undetectable viral load are eligible.
  • No other active cancers, except for certain non-threatening types.
  • Patients with symptomatic central nervous system (CNS) disease are not eligible.

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