Study on Inotuzumab Ozogamicin and Combination Chemotherapy for Treating Acute Lymphoblastic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01371630

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment combining inotuzumab ozogamicin with chemotherapy for patients with acute lymphoblastic leukemia (ALL). The study aims to find the best dose and see how well this combination works in treating the disease.

Patient Parameters

Program Overview

This study is exploring a new treatment for acute lymphoblastic leukemia (ALL) that combines a drug called inotuzumab ozogamicin with chemotherapy. Inotuzumab ozogamicin is a special type of drug that targets cancer cells and delivers a toxic substance to kill them. The study aims to find the safest and most effective dose of this drug when used with chemotherapy and to see how well it works in treating ALL. The trial is divided into two phases: Phase I focuses on finding the best dose, while Phase II evaluates the treatment's effectiveness and side effects.

Description

The study has several goals:

  • Phase I: To find the highest dose of inotuzumab ozogamicin that can be safely given with low-intensity chemotherapy to older patients (60 years and older) with acute lymphoblastic leukemia (ALL).
  • Phase II: To see how well the treatment works in older patients and those who cannot undergo intensive therapy. It also looks at the treatment's side effects and its effectiveness in patients whose ALL has returned or not responded to previous treatments.

The study also explores genetic changes in ALL that might predict how well patients respond to the treatment and uses advanced tests to measure minimal residual disease (MRD).

Study Design: The trial is conducted in two phases. In Phase I, the dose of inotuzumab ozogamicin is gradually increased to find the safest dose. In Phase II, the treatment's effectiveness is evaluated. Patients are divided into three groups based on their treatment history and health status.

  • Group 1 (Untreated): Patients receive a combination of chemotherapy drugs and inotuzumab ozogamicin in cycles, followed by maintenance therapy for up to three years.
  • Group 2 (Relapsed/Refractory): Patients whose cancer has returned or not responded to previous treatments receive a similar combination of drugs, with adjustments based on their condition.
  • Group 3 (70 Years and Older): Older patients receive a modified treatment plan with a focus on safety and tolerability.

After completing the study treatment, patients are monitored regularly to assess their health and the treatment's long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Patients aged 60 or older with newly diagnosed acute lymphoblastic leukemia (ALL) that is either Philadelphia chromosome positive or negative.
  • Patients aged 18 to 59 who are not fit for intensive therapy and have newly diagnosed ALL.
  • Patients aged 60 and older who cannot undergo intensive chemotherapy due to other health conditions.
  • Patients with a performance status score of 0 to 3, indicating varying levels of activity.
  • Adequate liver and kidney function as determined by specific blood tests.
  • Patients in their first remission or with certain types of relapsed or refractory ALL and related lymphomas.
  • Willingness to provide written informed consent to participate in the study.

Exclusion Criteria

  • Patients with newly diagnosed Burkitt's leukemia or lymphoma, T-cell ALL, or lymphoblastic lymphoma.
  • Patients with severe heart disease or a heart ejection fraction below 40%.
  • Patients with active hepatitis.
  • Pregnant or breastfeeding women.

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