Study on Blinatumomab, Inotuzumab Ozogamicin, and Chemotherapy for Treating B Acute Lymphoblastic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02877303

Provider View

This clinical trial is testing a combination of immunotherapy and chemotherapy drugs to see if they work better together as a first treatment for patients with B acute lymphoblastic leukemia (ALL).

Patient Parameters

Program Overview

This study is exploring how well a combination of treatments, including immunotherapy drugs blinatumomab and inotuzumab ozogamicin, along with various chemotherapy drugs, can treat patients with B acute lymphoblastic leukemia (ALL). The goal is to see if this combination can stop the cancer from growing and spreading more effectively than chemotherapy alone.

Description

The main goal of this study is to see how well the combination of chemotherapy drugs (cyclophosphamide, vincristine, doxorubicin, and dexamethasone) with blinatumomab and inotuzumab ozogamicin works in preventing the return of B-cell acute lymphoblastic leukemia (ALL) after treatment. Researchers also want to see how long patients live without the cancer coming back and how safe this treatment is.

The study is divided into different phases:

Intensive Phase: Patients receive a mix of chemotherapy drugs and possibly other medications over several cycles, each lasting about three weeks. This phase aims to aggressively target the cancer cells.

Blinatumomab and Inotuzumab Ozogamicin Phase: Patients receive blinatumomab continuously for four weeks and inotuzumab ozogamicin on specific days during the treatment cycles. This phase lasts for up to four cycles, each six weeks long.

Maintenance Phase: Patients may receive ongoing treatment to help keep the cancer from returning. This includes taking certain medications regularly and receiving blinatumomab after every few cycles of maintenance therapy.

After completing the study treatment, patients will have follow-up visits once a month for up to two years to monitor their health and any signs of cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed or previously untreated B-lineage ALL or lymphoblastic lymphoma, or in complete remission after one course of chemotherapy.
  • Patients who needed steroids or other medications to manage symptoms before diagnosis are eligible.
  • Performance status score between 0 and 3, indicating varying levels of activity.
  • Kidney function with creatinine levels at or below 2.0 mg/dL, unless related to the tumor.
  • Liver function with bilirubin levels at or below 2.0 mg/dL, unless related to the tumor.
  • Adequate heart function based on medical history and physical exam.
  • No other active cancers with a life expectancy of less than 12 months.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Known HIV-positive status.
  • Philadelphia chromosome-positive ALL.
  • Active or uncontrolled infections or diseases as determined by the doctor.
  • Unable or unwilling to sign the consent form.
  • Current active liver or bile duct disease, except for certain stable conditions.
  • History of significant brain or nervous system disorders, except for leukemia affecting the brain.
  • Current or past autoimmune diseases that could affect the brain or nervous system.

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