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Anti-metabolites
Pembrolizumab + Chemotherapy for Acute Myeloid Leukemia
Phase 2
Recruiting
Led By Amer M Zeidan
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 and <= 75 years
Cardiac risk assessment of class 2B or better
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to failure to achieve cr/cri, relapse or death from any cause, assessed up to 5 years
Awards & highlights
Study Summary
This trial is testing how well cytarabine, idarubicin, and daunorubicin work with or without pembrolizumab to treat patients with newly-diagnosed acute myeloid leukemia.
Who is the study for?
Adults aged 18-75 with newly diagnosed acute myeloid leukemia (AML) can join this trial. They must be healthy enough for intensive chemotherapy, have good organ function, and not have other active cancers or certain blood disorders. Pregnant women and those with a history of severe allergies to study drugs are excluded.Check my eligibility
What is being tested?
The trial is testing if adding pembrolizumab, an immune system booster, to standard AML chemotherapy (cytarabine and idarubicin or daunorubicin) is more effective than chemo alone in treating patients who are new to treatment.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in various organs, infusion reactions, fatigue, skin rash, digestive issues and increased risk of infections. Standard chemo can cause hair loss, nausea/vomiting, low blood cell counts leading to bleeding/infection risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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My heart health is assessed to be at low to moderate risk.
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I am mostly bedridden due to my health condition.
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I can take care of myself but might not be able to do heavy physical work.
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I have hepatitis B but my viral load is undetectable due to treatment.
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I am not pregnant.
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I am between 18 and 75 years old.
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I was treated for hepatitis C and am now cured or have an undetectable viral load.
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My kidney function, measured by creatinine or clearance, is within normal limits.
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I am 18 years or older and interested in a study involving pembrolizumab.
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I have been recently diagnosed with acute myeloid leukemia.
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I am fit for intensive chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to failure to achieve cr/cri, relapse or death from any cause, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to failure to achieve cr/cri, relapse or death from any cause, assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients with minimal residual disease - complete response (MRD-CR)
Rate of MRD-negative CR
Secondary outcome measures
Duration of response (DOR)
Event-free survival
Incidence of adverse events
+5 moreOther outcome measures
Genomic deoxyribonucleic acid (DNA) of tumor cells
Gut microbiome
Immune cell subsets
+6 moreSide effects data
From 2010 Phase 2 trial • 21 Patients • NCT0006042448%
Neutropenia
10%
Death following disease progression post transplant
10%
Thrombocytopenia
10%
Hyperbilirubinemia
10%
Hypoxia
5%
Typhlitis & Bowel Perforation
5%
Death following progression of GVHD
5%
Cardiac Arrhythmia and Seizure
5%
Death: Sepsis/Renal failure/ with history of GVHD
5%
Severe abnormal pain due to gut GVH
5%
Acute Pulmonary Embolism
5%
Perforated sigmoid diverticulitis
5%
Minimal hydronephosis
5%
Cholecystectomy
5%
Hypotension
5%
Increased creatinine
5%
Neurotoxicity
5%
Renal failure
5%
Tumor lysis syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (cytarabine, idarubicin, daunorubicin, HSCT)Experimental Treatment12 Interventions
See Detailed Description.
Group II: Arm II (cytarabine, idarubicin, daunorubicin, HSCT)Active Control11 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Biospecimen Collection
2004
Completed Phase 2
~1730
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Computed Tomography
2017
Completed Phase 2
~2720
Cytarabine
2016
Completed Phase 3
~3310
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5070
Echocardiography
2013
Completed Phase 4
~11670
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Idarubicin Hydrochloride
2013
Completed Phase 1
~50
Pembrolizumab
2017
Completed Phase 2
~2010
Punch Biopsy
2017
N/A
~40
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,663 Previous Clinical Trials
40,925,781 Total Patients Enrolled
Amer M ZeidanPrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
104 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active brain tumors or cancer in the lining of my brain.I am using hydroxyurea or leukapheresis for high white blood cell count.I am between 18 and 75 years old.I've used hydroxyurea or leukapheresis for high white blood cell count but can stop hydroxyurea before starting chemotherapy.My heart health is assessed to be at low to moderate risk.I haven't had chemotherapy or radiotherapy in the last 4 weeks.I have an active tuberculosis infection.I am mostly bedridden due to my health condition.I am still experiencing side effects from previous cancer treatments.I can take care of myself but might not be able to do heavy physical work.My doctor thinks I can handle strong chemotherapy.I have been newly diagnosed with AML, not from a prior cancer, and have not just extramedullary disease.I am on medication for an autoimmune disease.You have a mental health condition or other situations that may make it difficult for you to follow the study requirements.I have previously been treated with specific cancer drugs or experimental treatments.I have hepatitis B but my viral load is undetectable due to treatment.I am not pregnant.I have hepatitis B and am not on suppressive therapy.My kidney function, measured by creatinine or clearance, is within the required range.I am between 18 and 75 years old.You are currently enrolled in another study testing a new treatment.I was treated for hepatitis C and am now cured or have an undetectable viral load.I have another cancer that is getting worse or needs treatment.My kidney function, measured by creatinine or clearance, is within normal limits.I do not have any health issues that could affect the trial's results.I have lung inflammation not caused by infection, needing steroids.I am 18 years or older and interested in a study involving pembrolizumab.I have been recently diagnosed with acute myeloid leukemia.I have used specific treatments for my MDS but my AML is untreated, except for certain exceptions.I do not have any other active cancer.I am currently on medication for an infection.I am being treated for anemia that causes my red blood cells to break down.My leukemia is FLT3-mutated.I have been diagnosed with acute promyelocytic leukemia.I have had a transplant from another person.I have not received a live vaccine in the last 30 days.My heart's pumping ability is below 50%.I have a blood clotting disorder that can't be controlled with treatment.My cancer has not spread to my bone marrow.The level of creatinine in your blood will be measured to ensure it is within a safe range according to the hospital's standards.I am fit for intensive chemotherapy.I have used specific treatments for my previous MDS condition.I do not have any unmanaged ongoing illnesses.I am currently taking corticosteroids.You are currently pregnant or breastfeeding.My kidney function, measured by GFR, is within acceptable limits.I have recovered from any major surgery complications.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (cytarabine, idarubicin, daunorubicin, HSCT)
- Group 2: Arm II (cytarabine, idarubicin, daunorubicin, HSCT)
Awards:
This trial has 1 awards, including:- 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.
What maladies has Hematopoietic Cell Transplantation proven to be a successful cure for?
"Hematopoietic Cell Transplantation is a useful intervention for managing refractory, relapsed mediastinal large b-cell lymphoma. It has also been employed to effectively treat other diseases such as leukemia, myelocytic malignancies and various types of lymphomas."
Answered by AI
Is enrollment available for this clinical experiment at the moment?
"Affirmative, the clinical trial is actively enrolling patients according to information available on clinicaltrials.gov. Originally posted on June 1st 2020 and recently updated on September 30th 2022, this medical experiment seeks 124 participants from 7 different sites."
Answered by AI
Has Hematopoietic Cell Transplantation been granted official authorization by the FDA?
"The safety of Hematopoietic Cell Transplantation was rated a 2 due to the limited clinical evidence that exists in support of its efficacy, while there are some data points affirming its security."
Answered by AI
What is the geographic distribution of this trial?
"Clinical centres in New Haven, Orange and Chicago are actively recruiting for this study along with several other medical sites."
Answered by AI
What is the upper limit of participants in this clinical trial?
"Affirmative, the information hosted on clinicaltrials.gov attests that this study is in search of participants. Initially posted in June 2020 and last updated in September 2022, it calls for 124 volunteers to be recruited from 7 centres."
Answered by AI
Is this clinical research available to those over 45 years of age?
"This clinical trial is recruiting those aged 18 and older but under the age of 75."
Answered by AI
Is there an opportunity for me to participate in this trial?
"This medical trial is currently recruiting 124 patients of ages 18 to 75 with an acute myelocytic leukemia diagnosis. The patient must have had no prior use of HMA, lenalidomide, ESAs or growth factors – except if used for MDS treatment – and hydroxyurea/leukapheresis can be utilised to control hyperleukocytosis; however, it should stop before chemotherapy begins. Creatinine levels should not exceed 1.5x the Upper Limit Normal (ULN) or a CrCl score must be equal to at least 60mL/min for those with greater than ULN"
Answered by AI
What evidence exists to support the effectiveness of Hematopoietic Cell Transplantation?
"At present, there are 1220 clinical trials exploring Hematopoietic Cell Transplantation. Of those active studies, 187 have progressed to the third phase of testing. Although Scottsdale in Arizona is home to a concentration of these tests, 48065 sites across the world are carrying out research on this form of treatment."
Answered by AI
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