Study on Inotuzumab Ozogamicin for Treating Young Patients with B-Lymphoblastic Lymphoma or Relapsed/Refractory CD22 Positive B Acute Lymphoblastic Leukemia

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02981628

Provider View

This clinical trial is testing how well the drug inotuzumab ozogamicin works in young patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has returned or is not responding to treatment. The drug targets and kills cancer cells by attaching to them and delivering a toxic agent.

Patient Parameters

Program Overview

This study is exploring the effectiveness of inotuzumab ozogamicin, a drug that targets and kills specific cancer cells, in young patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back or is not responding to treatment. The drug works by attaching to cancer cells and delivering a toxic substance to destroy them.

Description

The main goal of this study is to see how well inotuzumab ozogamicin works after one cycle of treatment in children with relapsed or refractory CD22 positive B acute lymphoblastic leukemia (B-ALL). Researchers will also look at the response after two cycles, the safety of the drug, and the level of remaining cancer cells in patients who respond to the treatment. They will also study the side effects on the liver and the long-term survival of patients.

The study is divided into two groups:

  • Cohort 1: Patients receive inotuzumab ozogamicin through an IV on specific days of each cycle, repeating every 28 days for up to 6 cycles if the disease does not progress or cause unacceptable side effects.

  • Cohort 2: Patients receive inotuzumab ozogamicin along with other chemotherapy drugs. This treatment repeats every 42 days for up to 2 cycles if the disease does not progress or cause unacceptable side effects.

Patients will undergo various tests, including bone marrow aspiration, lumbar puncture, and blood sample collection throughout the trial. Imaging tests will also be conducted at the start and during the study. After completing the study treatment, patients will be followed up at 30 days, every 3 months for a year, and then yearly for four years.

Eligibility Criteria

Inclusion Criteria

  • Age between 1 and 22 years.
  • Diagnosed with B-ALL or B-lymphoblastic lymphoma with a certain percentage of cancer cells in the bone marrow.
  • Cancer cells must show CD22 markers at relapse.
  • Specific conditions for relapse or refractory disease, including previous treatments and relapses.
  • Patients with Down syndrome are eligible for Cohort 1 only.
  • Must have recovered from previous cancer treatments.
  • Meet specific health criteria, including kidney and liver function.
  • Must not have had certain treatments recently, such as stem cell transplants or CAR T-cell therapy, unless specified.
  • Must be able to provide informed consent and follow study procedures.

Exclusion Criteria

  • History of severe liver condition called sinusoidal obstruction syndrome (SOS).
  • Cancer relapse in specific areas like the central nervous system or testicles.
  • Previous treatment with inotuzumab ozogamicin.
  • Certain genetic syndromes or active infections.
  • Pregnant or breastfeeding women, or those not using effective contraception.
  • Patients currently on other investigational drugs or treatments not allowed by the study.
  • Known allergies to study drugs or similar compounds.

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