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Hypomethylation Agent
Pembrolizumab + Decitabine with or without Venetoclax for Acute Myeloid Leukemia or Myelodysplastic Syndrome
Phase 1
Recruiting
Led By Guido Marcucci
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Childbearing potential is defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
Refractory/relapsed AML by World Health Organization (WHO) classification, who are not candidates for allogeneic stem cell transplantation or potentially curative chemotherapy (Extramedullary disease is allowed).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the combination of the immunotherapy drug pembrolizumab with the drugs decitabine and venetoclax, to see if it is safe and effective in treating patients with newly-diagnosed, recurrent, or refractory acute myeloid leukemia or myelodysplastic syndrome.
Who is the study for?
This trial is for adults with newly-diagnosed, recurrent, or treatment-resistant acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants must be in good physical condition (ECOG status <=1), have a life expectancy of at least 3 months, and cannot be candidates for stem cell transplantation within the next 90 days. They should not have had certain previous treatments that were unsuccessful and must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dosage of pembrolizumab combined with decitabine, with or without venetoclax. Pembrolizumab is an immunotherapy drug; decitabine helps produce normal blood cells by affecting DNA; venetoclax targets proteins essential for cancer cell survival. The goal is to see how well these drugs work together against AML/MDS.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from the antibodies used in treatment, fatigue, digestive issues like nausea or constipation, low blood counts increasing infection risk, liver function changes and potential heart rhythm abnormalities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am capable of becoming pregnant or fathering a child.
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My AML has returned or didn't respond to treatment, and I can't have a stem cell transplant or curative chemo.
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My condition is confirmed as AML or MDS, not including a specific subtype.
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I am fully active and can carry on all pre-disease activities without restriction.
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I will not donate sperm during and for 6 months after treatment.
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My MDS has not improved or has returned after treatment.
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I am a woman who can have children and my pregnancy test is negative.
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I have recovered from side effects of cancer treatment, except for hair loss.
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My kidneys are functioning well enough to clear creatinine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum-tolerated dose (MTD)
Response to treatment
Secondary outcome measures
Overall survival
Progression-free survival
Response duration
Other outcome measures
Change in PD-1, PD-L1, and PD-L2 levels
Change in T cell receptor repertoire
Change in T cell subset distribution
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort II (pembrolizumab, decitabine)Experimental Treatment2 Interventions
Patients with MDS receive pembrolizumab IV over 30 minutes on days 1 and 22 and decitabine over 1 hour on days 1-5. Treatment repeats every 42 days for up to 8 cycles or 1 year from start of therapy, whichever comes first, in the absence of disease progression or unacceptable toxicity.
Group II: Cohort I Arm II (pembrolizumab, decitabine, venetoclax)Experimental Treatment3 Interventions
Patients with pembrolizumab IV over 30 minutes on days 1 and 22 and decitabine IV over 1 hour on days 1-10 or 1-5. Patients who achieve a CR receive decitabine on days 1-5. Patients also receive venetoclax PO QD on days 1-14. Treatment repeats every 42 days for up to 8 cycles or 1 year from start of therapy, whichever comes first, in the absence of disease progression or unacceptable toxicity.
Group III: Cohort I Arm I (pembrolizumab, decitabine)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on days 1 and 22 and decitabine IV over 1 hour on days 1-10. Patients who achieve a CR receive decitabine on days 1-5. Treatment repeats every 42 days for up to 8 cycles or 1 year from start of therapy, whichever comes first, in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Pembrolizumab
2017
Completed Phase 2
~2010
Venetoclax
FDA approved
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,606 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,800 Total Patients Enrolled
Guido MarcucciPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
7 Previous Clinical Trials
710 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My AML or MDS has not responded to previous treatments and I am not a candidate for a stem cell transplant or curative chemotherapy.I haven't taken strong or moderate CYP3A4 inducers in the last 14 days.I have a heart condition.I am capable of becoming pregnant or fathering a child.I have not been treated with drugs targeting PD-1, PD-L1, PD-L2, or similar.My AML has returned or didn't respond to treatment, and I can't have a stem cell transplant or curative chemo.I haven't taken GMCSF or GCSF in the last 7 days.I am not eligible for a specific stem cell transplant within 3 months of starting the study and have not taken pembrolizumab in the last month.I have fluid buildup in my abdomen or around my lungs causing symptoms.I have previously received treatments targeting the immune system.I had radiotherapy over 2 weeks ago, with no ongoing side effects.I am not using corticosteroids, except for nasal, topical, or as replacement therapy.I haven't had a recent heart attack or heart surgery in the last 6 months.I have an active tuberculosis infection.I have an active brain or spinal cord disease.I am not using, nor plan to use, other experimental drugs or cancer treatments during the study.My condition worsened despite treatment with decitabine and venetoclax.I am not pregnant or breastfeeding.My condition is confirmed as AML or MDS, not including a specific subtype.My heart's electrical activity is normal as per my recent ECG.I am fully active and can carry on all pre-disease activities without restriction.I do not have any uncontrolled serious illnesses.I will not donate sperm during and for 6 months after treatment.I have taken hydroxyurea for my leukemia and may continue it through cycle 2 with venetoclax.I am currently fighting an infection that needs treatment.My MDS has not improved or has returned after treatment.I am a woman who can have children and my pregnancy test is negative.I have recovered from side effects of cancer treatment, except for hair loss.I have unstable chest pain.I have a specific diagnosis.I agree to use effective birth control or abstain from sex during and up to 4 months after the study.I have severe heart failure or my moderate heart failure has recently worsened.I have had a stem cell transplant from a donor.I have an autoimmune disease but haven't needed systemic treatment in the last 2 years, except for hormone replacements.My white blood cell count is low enough to start treatment.My kidneys are functioning well enough to clear creatinine.I am not on steroids or any immunosuppressive medications.I have been treated with pembrolizumab before.I have not received a live-virus vaccine within the last 30 days.I have mild COPD, controlled asthma, or had pneumonia/PE that's now resolved.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort II (pembrolizumab, decitabine)
- Group 2: Cohort I Arm II (pembrolizumab, decitabine, venetoclax)
- Group 3: Cohort I Arm I (pembrolizumab, decitabine)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies in this research endeavor for participants?
"Affirmative. Clinicaltrials.gov shows that this research endeavour, first posted on May 4th 2020, is still actively recruiting patients. The trial seeks 54 participants between two sites."
Answered by AI
What is the intake capacity for this experiment?
"Indeed, the details on clinicaltrials.gov demonstrate that this research is actively looking for test subjects. The trial was initially posted in May of 2020 and underwent a revision as recently as March 2022. 54 individuals need to be recruited from 2 different medical centres."
Answered by AI
Is Pembrolizumab currently being tested in other research studies?
"Currently, 1058 Pembrolizumab-focused clinical trials are in progress with 137 of them being Phase 3 trials. Most of the studies are located near Houston, Texas but there are 37199 different sites around the world participating in these experiments."
Answered by AI
What medicinal applications is Pembrolizumab commonly utilized for?
"Patients with unresectable melanoma, high microsatellite instability, and a heightened risk of relapse can be aided by Pembrolizumab."
Answered by AI
Has the FDA sanctioned Pembrolizumab for medical use?
"This drug is currently in the early stages of clinical research, so its safety was estimated to be a 1. As such, there is only limited data available which can attest to both efficacy and safety."
Answered by AI
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