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E-selectin Antagonist
Uproleselan + Chemotherapy for Acute Myeloid Leukemia
Phase 3
Waitlist Available
Led By Daniel J DeAngelo, MD, PhD
Research Sponsored by GlycoMimetics Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years and ≤75 years in age
No more than one prior stem cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will compare the effects of adding the drug uproleselan to standard chemotherapy in patients with relapsed or refractory acute myeloid leukemia.
Who is the study for?
Adults aged 18-75 with relapsed or refractory Acute Myeloid Leukemia (AML) who haven't had more than one stem cell transplant and are medically eligible for chemotherapy. Excluded are those with recent use of certain growth factors, immunotherapy, radiotherapy, or chemotherapy; inadequate organ function; active hepatitis or HIV; moderate kidney dysfunction; uncontrolled infections; major surgery within the last month; specific types of leukemia other than AML.Check my eligibility
What is being tested?
The trial is testing Uproleselan (GMI-1271), an E-selectin antagonist drug, combined with standard chemotherapy against a placebo plus chemotherapy in patients with relapsed/refractory AML. The goal is to see if Uproleselan improves treatment outcomes compared to the usual approach.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, changes in blood counts leading to increased risk of infection or bleeding, nausea and vomiting from chemotherapy, liver function abnormalities, fatigue and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I have had only one stem cell transplant.
Select...
My AML cancer has returned or is not responding to treatment.
Select...
I have not received the specific chemotherapy planned for this trial before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Overall response rate
Rate of severe oral mucositis
Other outcome measures
Adverse events
Duration of remission
Event-free survival
+2 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%
Enterocolitis Infectious
12%
Alanine aminotransferase increased
12%
Blood bilirubin increased
12%
Musculoskeletal and Connective Tissue Disorder - other
12%
Gastroesophageal Reflux Disease
12%
Eye Disorders - other
12%
Dehydration
12%
Hyperglycemia
12%
Activated partial thromboplastin time prolonged
12%
Skin Infection
8%
Wheezing
8%
Anxiety
8%
Pain in Extremity
8%
Hyperphosphatemia
8%
Periorbital Edema
8%
Hypoglycemia
8%
Generalized Muscle Weakness
8%
Peripheral Sensory Neuropathy
8%
Bruising
8%
Dyspnea
8%
Skin and Subcutaneous Tissue Disorders - other
8%
Febrile neutropenia
8%
Creatinine increased
8%
Bloating
8%
Flatulence
8%
Headache
8%
Hypernatremia
8%
Aspartate aminotransferase increased
8%
Infusion Site Extravasation
4%
Adrenal Insufficiency
4%
Respiratory, Thoracic, and Mediastinal Disorders - other
4%
Facial Pain
4%
Vision Decreased
4%
Nervous System Disorders - other
4%
Dysphagia
4%
Hyperkalemia
4%
Lethargy
4%
Insomnia
4%
Allergic Rhinitis
4%
Chills
4%
Localized Edema
4%
Bacteremia
4%
Sepsis
4%
Urinary Tract Infection
4%
Muscle Cramp
4%
Restlessness
4%
Hematuria
4%
Testicular Pain
4%
Cough
4%
Hypertension
4%
Lung Infection
4%
Papulopustular Rash
4%
Neoplasms benign, malignant, and unspecified (incl cysts and polyps) - other
4%
Psychiatric 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Uproleselan (GMI-1271)Experimental Treatment1 Intervention
Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
Group II: Placebo (Saline, 0.9% Sodium Chloride)Placebo Group1 Intervention
Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Uproleselan
2018
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
GlycoMimetics IncorporatedLead Sponsor
22 Previous Clinical Trials
1,124 Total Patients Enrolled
Daniel J DeAngelo, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 75 years old.I have had only one stem cell transplant.I haven't used G-CSF, GM-CSF, or plerixafor in the last 7 days.My leukemia is one of the specific types not eligible for this trial.My cancer is affecting my brain or spinal cord.I had a stem cell transplant less than 4 months ago.I haven't had immunotherapy, radiotherapy, or any experimental treatments in the last 28 days.My kidneys are not working well.My AML cancer has returned or is not responding to treatment.I do not have an active hepatitis A, B, C, or HIV infection.I do not have any severe, uncontrolled infections.I have not had major surgery in the last 4 weeks.I have not received the specific chemotherapy planned for this trial before.My doctor says I can handle the chemotherapy for this trial.I have a serious heart condition.My organs are not functioning properly.My liver isn't working properly.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo (Saline, 0.9% Sodium Chloride)
- Group 2: Uproleselan (GMI-1271)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has Uproleselan been cleared by the FDA?
"Uproleselan is being tested in a Phase 3 clinical trial, so there is some evidence of efficacy and multiple rounds of data supporting safety."
Answered by AI
Are other hospitals in this state conducting this research?
"There are 33 sites enrolling patients in this trial, with locations in Oklahoma City, Cleveland, and Dallas. To minimize travel requirements, patients are encouraged to enroll at the closest site."
Answered by AI
What is the total number of people allowed to participate in this test phase of the treatment?
"Although this clinical trial was last updated on 4/5/2022, it is not currently enrolling patients. If you are looking for other active trials, there are 1591 trials for leukemia, myelocytic, acute and 6 trials for Uproleselan that are still recruiting."
Answered by AI
Are young people still being allowed to enroll in this experiment?
"This trial is only for people aged 18-75. If you're looking for trials for people under 18, there are 462 options. For those over 65, 1281 trials are available."
Answered by AI
Which patients would be the best candidates to sign up for this type of research?
"This study is enrolling 388 patients with acute myelocytic leukemia who meet the following additional criteria: being between 18-75 years old, being eligible for the study's chemotherapy regimen, having had no more than one prior stem cell transplant, and not having received the chemotherapy regimen to be used for induction in this trial."
Answered by AI
What other medical studies have included Uproleselan as a testing subject?
"Uproleselan was first studied in 2018. Since then, there have been 18268 completed trials, with 6 more presently underway. The majority of these latter trials are based in Oklahoma City, Oklahoma."
Answered by AI
What precedent does this clinical trial set?
"Since 2018, there has been an ongoing effort to study the effects of Uproleselan. In 2018, the first trial was completed with the sponsorship of GlycoMimetics Incorporated. There are now 6 active trials in 41 cities and 10 countries."
Answered by AI
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