RecruitingPhase 1NCT03969446

Pembrolizumab and Decitabine With or Without Venetoclax in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome That Is Newly-Diagnosed, Recurrent, or Refractory

Phase 1b Study of Pembrolizumab, Decitabine +/- Venetoclax Combination Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome


Sponsor

City of Hope Medical Center

Enrollment

54 participants

Start Date

May 4, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib trial studies the side effects and best dose of pembrolizumab and how well it works in combination with decitabine with or without venetoclax in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly-diagnosed, has come back (recurrent), or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. This trial may help doctors find the best dose of pembrolizumab that can be safely given in combination with decitabine with or without venetoclax, and to determine what side effects are seen with this treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study combines three drugs — pembrolizumab (an immunotherapy), decitabine (a chemotherapy), and venetoclax (a targeted therapy) — to treat blood cancers including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) that are newly diagnosed, have come back, or have stopped responding to treatment. **You may be eligible if...** - You have confirmed AML or MDS - Your AML has relapsed or is refractory (not responding) and you are not a candidate for stem cell transplant - Your MDS has not responded to previous treatments - Your general health and daily function level (ECOG) is 0 or 1 (able to carry out normal activities) **You may NOT be eligible if...** - You have acute promyelocytic leukemia (a specific subtype) - Your health status is too poor - Required lab values are not within acceptable range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDecitabine

Given IV

BIOLOGICALPembrolizumab

Given IV

DRUGVenetoclax

Given PO


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT03969446


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