Actively Recruiting
Pembrolizumab and Decitabine With or Without Venetoclax in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome That Is Newly-Diagnosed, Recurrent, or Refractory
Led by City of Hope Medical Center · Updated on 2026-03-05
54
Participants Needed
1
Research Sites
373 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab and Decitabine With or Without Venetoclax in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome That Is Newly-Diagnosed, Recurrent, or Refractory
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent
- Allowed use of archival blood and marrow samples or approval from study investigator
- ECOG performance status of 0 or 1
- Histologically confirmed acute myeloid leukemia (excluding acute promyelocytic leukemia) or myelodysplastic syndrome
- Diagnosed with refractory or relapsed AML not eligible for stem cell transplant or curative chemotherapy, or MDS with failed or relapsed previous therapies
- Life expectancy of at least 3 months
- Fully recovered from prior anti-cancer therapy effects except hair loss
- Not eligible for allogeneic hematopoietic cell transplantation within 90 days of starting treatment
- Off pembrolizumab at least 30 days before possible transplantation after study
- White blood cell count less than or equal to 25 x 10^9/L before venetoclax; hydroxyurea allowed for cytoreduction
- Total bilirubin less than or equal to twice the upper normal limit unless Gilbert's disease
- AST and ALT less than or equal to 2.5 times the upper normal limit
- Creatinine clearance over 30 mL/min
- INR or prothrombin time less than or equal to 1.5 times the upper normal limit
- Activated partial thromboplastin time less than or equal to 1.5 times the upper normal limit
- Left ventricular ejection fraction of 50% or higher
- Lung diffusion capacity over 50% predicted
- Corrected QT interval less than or equal to 480 milliseconds
- Negative for HIV antigen/antibody, hepatitis C, and active hepatitis B
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during and after study
- Male participants agree to avoid sperm donation during and after study
You will not qualify if you...
- Previous allogeneic cell transplantation
- Previous treatment with pembrolizumab
- Refractory to decitabine plus venetoclax without at least partial response
- Current systemic steroid or other immunosuppressive therapy
- Live-virus vaccination within 30 days before treatment start
- Prior treatment with other anti-PD-1, PD-L1, PD-L2 agents, or related immuno-modulating antibodies
- Use of other investigational, antineoplastic, biological, or chemotherapeutic agents during or shortly before study (except allowed hydroxyurea)
- Use of strong or moderate CYP3A4 inducers within 14 days before venetoclax
- Consumption of grapefruit or related products within 3 days before venetoclax
- Radiotherapy within 2 weeks before study start unless recovered and without corticosteroids or pneumonitis
- Use of corticosteroids except nasal, topical, or replacement doses
- Use of granulocyte growth factors within 7 days before treatment
- History of allergic reactions to similar study agents
- Severe hypersensitivity to other monoclonal antibodies
- Active central nervous system disease
- Unstable angina, congestive heart failure (certain classes), recent acute coronary syndrome or revascularization
- Pulmonary dysfunction including pneumonitis, idiopathic pulmonary fibrosis, or uncontrolled lung disease
- Active autoimmune disease needing systemic treatment in past 2 years
- Uncontrolled infection
- Known active tuberculosis
- Symptomatic ascites or pleural effusion
- Clinically significant uncontrolled illness
- Pregnant or breastfeeding females
- Other conditions judged by investigator to contraindicate participation
- Inability to comply with study procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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