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Anti-metabolites
Uproleselan + Azacitidine + Venetoclax for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Brian A Jonas
Research Sponsored by Brian Jonas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Cardiac history of congestive heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) =< 50% or chronic stable angina
White blood cell (WBC) =< 25,000/mm^3 at the start of study therapy (leukapheresis and hydroxyurea are allowed to meet this criteria). No other hematologic parameters
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat leukemia in patients who are older or unable to have standard treatment.
Who is the study for?
This trial is for adults with newly diagnosed acute myeloid leukemia who are older or unfit for intensive chemotherapy. They must understand and consent to the study, have a certain level of physical function (ECOG status), and agree to use contraception if necessary. Exclusions include other recent cancers, prior treatments for AML, active infections like HIV or hepatitis, severe medical conditions that could interfere with treatment, or pregnancy.Check my eligibility
What is being tested?
The trial tests uproleselan combined with azacitidine and venetoclax in patients who haven't been treated before for acute myeloid leukemia. Uproleselan may prevent cancer growths; azacitidine stops cancer cells from growing by various means; venetoclax blocks proteins essential for cancer cell survival.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to the drugs, possible organ inflammation due to uproleselan, blood cell count changes from azacitidine affecting oxygen transport and clotting risk, as well as fatigue and digestive issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a heart condition like CHF, LVEF ≤ 50%, or stable angina.
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My white blood cell count is less than or equal to 25,000/mm^3.
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I have not received any treatment and am eligible for venetoclax plus HMA therapy.
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I am 18 years old or older.
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My condition is officially diagnosed as AML according to WHO 2016 criteria.
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My kidneys are functioning well, with a creatinine clearance rate of at least 45 mL/min.
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I have not had my uterus or both ovaries removed.
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I have had a menstrual period in the last 12 months.
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I need some help with daily activities due to my health condition.
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I am 75 years old or older.
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I can swallow and keep down pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 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
Recommended phase II dose
Secondary outcome measures
Duration of CR/CRi and CR/CRh (DoR)
Event-free survival (EFS)
Overall response rate (ORR)
+5 moreSide effects data
From 2022 Phase 2 trial • 51 Patients • NCT04682405100%
White blood cell decreased
100%
Neutrophil count decreased
100%
Hypocalcemia
100%
Diarrhea
100%
Platelet count decreased
96%
Anemia
96%
Nausea
92%
Lymphocyte count decreased
88%
Fatigue
88%
Hypoalbuminemia
81%
Abdominal Pain
81%
Hypophosphatemia
81%
INR increased
69%
Hypokalemia
65%
Vomiting
50%
Esophageal Pain
50%
Mucositis oral
38%
Esophagitis
35%
Enterocolitis
35%
Constipation
35%
Fever
35%
Malaise
31%
Hyponatremia
31%
Hypotension
27%
Thrush
23%
Gastritis
23%
Dizziness
19%
Back Pain
19%
Hemorrhoids
15%
Proctitis
15%
Edema Limbs
15%
Anorexia
12%
Infections and Infestations - other
12%
Musculoskeletal and Connective Tissue Disorder - other
12%
Enterocolitis Infectious
12%
Alanine aminotransferase increased
12%
Blood bilirubin increased
12%
Gastroesophageal Reflux Disease
12%
Eye Disorders - other
12%
Dehydration
12%
Hyperglycemia
12%
Activated partial thromboplastin time prolonged
12%
Skin Infection
8%
Skin and Subcutaneous Tissue Disorders - other
8%
Generalized Muscle Weakness
8%
Anxiety
8%
Pain in Extremity
8%
Wheezing
8%
Hyperphosphatemia
8%
Periorbital Edema
8%
Hypoglycemia
8%
Peripheral Sensory Neuropathy
8%
Bruising
8%
Dyspnea
8%
Febrile neutropenia
8%
Creatinine increased
8%
Bloating
8%
Flatulence
8%
Headache
8%
Hypernatremia
8%
Aspartate aminotransferase increased
8%
Infusion Site Extravasation
4%
Urinary Tract Infection
4%
Neoplasms benign, malignant, and unspecified (incl cysts and polyps) - other
4%
Nervous System Disorders - other
4%
Adrenal Insufficiency
4%
Facial Pain
4%
Vision Decreased
4%
Dysphagia
4%
Hyperkalemia
4%
Lethargy
4%
Insomnia
4%
Allergic Rhinitis
4%
Chills
4%
Localized Edema
4%
Bacteremia
4%
Sepsis
4%
Muscle Cramp
4%
Restlessness
4%
Hematuria
4%
Testicular Pain
4%
Cough
4%
Hypertension
4%
Lung Infection
4%
Papulopustular Rash
4%
Psychiatric Disorders - other
4%
Respiratory, Thoracic, and Mediastinal Disorders - other
4%
Delirium
4%
Sinus Tachycardia
4%
Encephalopathy
4%
Dysuria
4%
Toothache
4%
Sinusitis
4%
Dry Mouth
4%
Fall
4%
Pulmonary Edema
4%
Non-cardiac Chest Pain
4%
Alkaline phosphatase increased
4%
Nasal Congestion
4%
Otitis Externa
4%
Extraocular Muscle Paresis
4%
Blurred Vision
4%
Generalized Edema
4%
Confusion
4%
Hallucinations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Uproleselan + Standard of Care Melphalan
Placebo + Standard of Care Melphalan
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (uproleselan, azacitidine, venetoclax)Experimental Treatment3 Interventions
Patients receive uproleselan IV over 1 hour Q12H on days 1-7, azacitidine IV or SC QD on days 1-7, and venetoclax PO QD on days 1-28. Beginning cycle 5, patients achieving MLFS or better response, may receive azacitidine IV or SC QD and uproleselan IV over 1 hour QD on days 1-6 and 8 or days 1-5 and 8-9 or days 1-5. Treatment with uproleselan repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Cycles with azacitidine and venetoclax repeat every 28 days in the absence of disease progression and unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
Uproleselan
Not yet FDA approved
Venetoclax
FDA approved
Find a Location
Who is running the clinical trial?
Brian JonasLead Sponsor
4 Previous Clinical Trials
65 Total Patients Enrolled
GlycoMimetics IncorporatedIndustry Sponsor
22 Previous Clinical Trials
1,487 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,829 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 74 years old and have at least one health condition.I haven't taken any strong or moderate CYP3A inducers in the last week.My heart condition limits my physical activity significantly.I have had cancer before, but it was either treated successfully over a year ago, was a non-melanoma skin cancer, or was localized prostate or cervical cancer that is now cured.I am not pregnant or nursing.I have a heart condition like CHF, LVEF ≤ 50%, or stable angina.My white blood cell count is less than or equal to 25,000/mm^3.I agree to use effective birth control during and 90 days after the study.My AML has not been treated before, except for specific prior treatments allowed.I am a woman who could potentially become pregnant.I am 75 or older with a health status score of 0 to 2.I have not received any treatment and am eligible for venetoclax plus HMA therapy.I am 18 years old or older.My condition is officially diagnosed as AML according to WHO 2016 criteria.My kidneys are functioning well, with a creatinine clearance rate of at least 45 mL/min.I have not had my uterus or both ovaries removed.I have been diagnosed with acute promyelocytic leukemia.I am between 18 and 74 years old.I have had a menstrual period in the last 12 months.I do not have active HIV or hepatitis A, B, or C, or if I do, my viral load has been undetectable for the last 3 months.I am a woman who can have children and have a negative pregnancy test before starting the study drug.I haven't had cancer treatments or investigational therapy within the last 14 days or 5 half-lives, and no biologic agents in the last 30 days.I am over 65 and my kidney function, measured by creatinine clearance or serum creatinine, meets the required levels.I don't have any severe illnesses that would stop me from following the study's treatment plan.My acute myeloid leukemia has spread to my brain or spinal cord.You are currently using or planning to use other experimental drugs.I cannot take medicine by mouth due to a digestive condition.I need some help with daily activities due to my health condition.I am 75 years old or older.I do not have an ongoing infection that needs treatment.I can swallow and keep down pills.You have eaten grapefruit, grapefruit products, Seville oranges, or starfruit within the last 3 days before starting the study treatment.You have had allergic reactions to similar medicines or substances like the ones used in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (uproleselan, azacitidine, venetoclax)
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Is there a documented history of research into the therapeutic effects of Uproleselan?
"Currently, there are 345 ongoing trials for Uproleselan with 56 studies in the third phase. Although several of these tests occur out of Edmonton, Alberta; a total of 11265 locations around the globe are running clinical trials involving Uproleselan."
Answered by AI
What is the main focus of this investigation?
"According to the research sponsor, GlycoMimetics Incorporated, this trial will be measuring a Recommended Phase II Dose as its primary outcome over an interval of up to thirty days. The secondary outcomes include Duration of CR/CRi and CR/CRh (DoR), Rate of Transfusion-Independence (TI) and Rate of Multiparameter Flow Cytometry (MFC) Measurable/Minimal Residual Disease (MRD)-Negative Complete Remission plus CR with Incomplete Count Recovery. Descriptive statistics such as means, medians and percentiles alongside Exact 95%"
Answered by AI
What conditions tend to be treated with Uproleselan?
"Uproleselan is generally used in induction chemotherapy, but can also prove effective for refractory anemias, various forms of leukemia and dysplasias involving multiple lineages."
Answered by AI
Are there still opportunities to enroll in this experiment?
"Clinicaltrials.gov shows that this clinical experiment is currently recruiting participants. It was initially uploaded on July 2nd 2021 and was recently revised on August 12th 2022."
Answered by AI
What evidence is there to support the safety of Uproleselan when administered to humans?
"There is limited evidence surrounding its safety and efficacy, so Uproleselan received a rating of 1."
Answered by AI
How many participants are allowed to join this research endeavor?
"Affirmative. Clinicaltrials.gov documentation indicates that this experiment, which was introduced on July 2nd 2021, is actively recruiting subjects. Approximately 25 people need to be enrolled from 1 medical facility."
Answered by AI
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