Study on Pembrolizumab and Blinatumomab for Treating Recurrent or Resistant Acute Lymphoblastic Leukemia

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03512405

Provider View

This clinical trial is testing the safety and effectiveness of two drugs, pembrolizumab and blinatumomab, in treating patients with acute lymphoblastic leukemia (ALL) that has returned or not responded to previous treatments. These drugs are monoclonal antibodies that may help stop cancer cells from growing and spreading.

Patient Parameters

Program Overview

This study is exploring the use of pembrolizumab and blinatumomab to treat acute lymphoblastic leukemia (ALL) that has come back or hasn't responded to treatment. The trial aims to understand the side effects and how well these drugs work together. Pembrolizumab and blinatumomab are types of monoclonal antibodies that may help prevent cancer cells from growing and spreading.

Description

The study is divided into two phases. In Phase I, the focus is on assessing the safety and side effects of the combination of pembrolizumab and blinatumomab. Researchers will look at the types, frequency, and severity of any side effects. They will also determine the best schedule for giving these drugs together. In Phase II, the study will evaluate how effective the treatment is in reducing leukemia, looking at the overall response rate, which includes complete response or complete response with incomplete recovery.

Secondary goals include estimating how quickly patients respond to the treatment and how long the response lasts, overall survival rates, and the number of patients who undergo stem cell transplantation after treatment. The study will also look at how many patients continue pembrolizumab treatment for up to a year and the rate of minimal residual disease.

Participants will receive pembrolizumab through an IV on specific days of the treatment cycle and blinatumomab continuously for 28 days. The treatment cycles repeat every 35-42 days for up to 5 cycles, unless the disease progresses or side effects become unacceptable. Patients who achieve a complete response may receive additional cycles of blinatumomab.

After completing the study treatment, participants will have follow-up visits at 30 days and then every 3 months for a year.

Eligibility Criteria

Inclusion Criteria

  • Have been previously treated for acute lymphoblastic leukemia (ALL), including Philadelphia chromosome-positive ALL.
  • Diagnosed with CD19-positive B-cell ALL.
  • Have leukemia that did not respond to initial treatment or has returned after treatment.
  • Have detectable cancer cells in the bone marrow or other areas that can be measured and biopsied.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have a heart function with an ejection fraction over 45%.
  • Have adequate lung function with a DLCO over 50%.
  • Have normal kidney function or creatinine clearance over 60 ml/min.
  • Have normal liver function tests within specified limits.
  • Have adequate blood clotting function.
  • Test negative for pregnancy, HIV, hepatitis B, and hepatitis C.
  • Have stopped all previous cancer treatments for a specified period before starting the study.
  • Be willing to use effective contraception during the study and for a specified period after the last dose.
  • Be able to understand and sign a written informed consent form.

Exclusion Criteria

  • Have a diagnosis of mature B-cell ALL or lymphoid blast crisis of chronic myelogenous leukemia.
  • Have a life-threatening illness or medical condition that could interfere with the study.
  • Have active or symptomatic central nervous system disease.
  • Have uncontrolled illnesses, such as unstable angina or psychiatric conditions.
  • Have a history of myelodysplastic syndrome or organ transplantation.
  • Have a history of other cancers, except for certain non-threatening types.
  • Have known allergies to pembrolizumab or blinatumomab.
  • Have ongoing liver disease or infections like hepatitis or HIV.
  • Have had a prior bone marrow transplant.
  • Be pregnant or breastfeeding.
  • Have a history of non-infectious pneumonitis.
  • Be participating in another investigational drug trial.
  • Have had recent chemotherapy, targeted therapy, or radiation therapy.
  • Have active autoimmune disease requiring treatment in the past 2 years.
  • Have known psychiatric or substance abuse disorders that interfere with the study.
  • Have received prior therapy with similar drugs or a live vaccine recently.

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