Study on Chemotherapy-Free Treatment for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Using Inotuzumab Ozogamicin (InO)

Sponsor: University of Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04747912

Provider View

This clinical trial is exploring the addition of a drug called Inotuzumab Ozogamicin (InO) to the treatment plan for patients newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The aim is to see if InO can help achieve a complete remission faster, where the disease is undetectable even with sensitive tests.

Patient Parameters

Program Overview

The study is testing whether adding Inotuzumab Ozogamicin (InO) to the initial treatment for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) can lead to a quicker and complete remission. This means the disease would not be detectable even with very sensitive testing methods. The research aims to gather information on how effective InO is for patients who have just been diagnosed with Ph+ ALL and have not yet started treatment.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with Philadelphia chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ ALL) with CD22 present on at least 20% of cancer cells.
  • 18 years or older.
  • Cancer in the bone marrow with at least 20% lymphoblasts and confirmation of BCR-ABL1 through specific tests. Patients with more than 1000 lymphoblasts in the blood who cannot have a bone marrow biopsy due to health reasons are also eligible.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Adequate organ function as shown in medical records.
  • At least 2 weeks since major surgery, radiation, or participation in other trials, and recovery from any significant side effects of these treatments.
  • Must sign an informed consent form approved by an ethics committee before starting any study procedures.
  • Women who can have children must use effective birth control during treatment and for 8 months after the last dose. Men with partners who can have children must use effective birth control during treatment and for 5 months after the last dose.
  • Willing and able to attend scheduled visits, follow the treatment plan, and undergo tests and procedures required by the study.

Exclusion Criteria

  • Cancer that is only outside the bone marrow.
  • Burkitt's or mixed-lineage leukemia.
  • Active leukemia in the central nervous system.
  • Any previous treatment for ALL except for limited use of corticosteroids or hydroxyurea and one dose of intrathecal therapy. Patients on chronic steroids for other conditions are eligible.
  • Current or chronic hepatitis B or C infection, or known HIV positivity, unless HIV is controlled with an undetectable viral load.
  • Major surgery within 2 weeks before starting the study.
  • Unstable or severe uncontrolled medical conditions.
  • Another active cancer, except for certain skin cancers or localized prostate cancer treated with surgery or radiation.
  • Uncontrolled heart disease.
  • Specific heart rhythm issues (QTcF > 500 msec).
  • Chronic liver disease or suspected alcohol abuse.
  • History of certain liver conditions (VOD or SOS).
  • Uncontrolled serious infections.
  • Medications that increase the risk of heart rhythm problems are not allowed during the study.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Employees or relatives of the study site staff or Pfizer employees involved in the trial.
  • Participation in other studies during the active treatment phase.
  • Other severe medical or psychiatric conditions that could increase risk or interfere with the study.

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