Study on Adding Pembrolizumab to Standard Chemotherapy for Treating Acute Myeloid Leukemia

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04214249

Provider View

This clinical trial is testing whether adding the immunotherapy drug pembrolizumab to standard chemotherapy can improve treatment outcomes for patients with newly diagnosed acute myeloid leukemia (AML).

Patient Parameters

Program Overview

This study is exploring if combining the immunotherapy drug pembrolizumab with standard chemotherapy drugs cytarabine and idarubicin or daunorubicin can better treat patients with newly diagnosed acute myeloid leukemia (AML). Chemotherapy works by killing cancer cells or stopping them from growing, while pembrolizumab helps the immune system attack cancer cells. The study aims to see if this combination is more effective than chemotherapy alone.

Description

The main goal of this study is to see how many patients achieve complete remission, meaning no detectable cancer, after receiving chemotherapy with pembrolizumab. Researchers will compare results between two groups: one receiving chemotherapy with pembrolizumab and the other receiving chemotherapy alone.

Secondary goals include evaluating the overall response to treatment, how long patients remain cancer-free, and the safety of the treatment. The study will also explore how the immune system responds to the treatment and whether certain biological markers can predict treatment success.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will receive chemotherapy with cytarabine and idarubicin or daunorubicin, along with pembrolizumab.
  • Group 2: Will receive chemotherapy with cytarabine and idarubicin or daunorubicin without pembrolizumab.

Both groups will undergo a series of treatment cycles, including an initial phase to reduce cancer cells and a consolidation phase to maintain remission. Some patients may also receive a stem cell transplant if deemed appropriate by their doctor.

Participants will have regular check-ups, including blood tests and bone marrow biopsies, to monitor their response to treatment and any side effects. After completing the study treatment, participants will be followed up for up to five years to track their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with acute myeloid leukemia (AML) confirmed by bone marrow or blood tests.
  • Aged between 18 and 75 years.
  • Able to receive intensive chemotherapy as determined by the doctor.
  • Previously untreated AML, except for certain allowed treatments like hydroxyurea.
  • Adequate kidney and liver function as shown by specific blood tests.
  • Stable HIV or hepatitis infections, if present, with undetectable viral loads.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study.
  • Men must agree to use contraception if they have partners of childbearing potential.
  • Willing to sign an informed consent form and follow study procedures.

Exclusion Criteria

  • Have another active cancer that requires treatment.
  • Have received certain cancer treatments recently, such as anthracyclines or immunotherapy.
  • Have a heart condition with reduced heart function.
  • Have a specific genetic mutation in the FLT3 gene.
  • Have not recovered from side effects of previous cancer treatments.
  • Have a history of severe allergic reactions to pembrolizumab or similar drugs.
  • Are currently using corticosteroids, except for low doses for non-cancer conditions.
  • Have active central nervous system disease or untreated brain metastases.
  • Have an active autoimmune disease requiring treatment.
  • Have an active, uncontrolled infection or tuberculosis.
  • Are pregnant or breastfeeding.
  • Have received a live vaccine recently.
  • Have certain blood disorders or no bone marrow involvement.

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