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Tyrosine Kinase Inhibitor
Imatinib for Sickle Cell Anemia (IMPACT Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
a. Adequate bone marrow function defined as i. Peripheral absolute neutrophil count (ANC) ≥1000/µL ii. Platelet count ≥100,000/ µL (transfusion independent) b. Adequate renal function defined as i. Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥70 mL/min/1.73 m2 or ii. A serum creatinine based on age/gender c. Adequate Liver Function Defined As: i. Total bilirubin (sum of conjugated + unconjugated) ≤1.5 times upper limit of normal (ULN) for age, and ii. serum glutamate pyruvate transaminase (SGPT or ALT) <2.5 upper limit of normal. For the purpose of this study, the ULN for SGPT is 45 U/L iii. Serum albumin ≥2 g/dL d. Adequate cardiac function defined as: i. Shortening fraction or ejection fraction greater than the institutional norm, and ii. Corrected QT interval ≤450 msec
Performance Level: Karnofsky ≥80 for patients >10 years of age and Lansky ≥80 for patients ≤10 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
Must not have
The following CYP3A4 inducers are prohibited 14 days before the start of imatinib and during the study with imatinib: rifampin, rifabutin, carbamazepine, Phenobarbital, phenytoin, St. John's wort, efavirenz, and tipranavir.
a. Patients currently on a chronic transfusion protocol are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline band 3 phosphorylation at 7 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group
Summary
This trial tests a pill used for other diseases on patients with sickle cell disease. The goal is to see if it can lower harmful proteins and particles in their blood. Researchers hope this will reduce pain crises and other complications over several months.
Who is the study for?
This trial is for individuals aged 18-25 with sickle cell disease who've had at least two vaso-occlusive pain episodes in the past year. They must have a certain level of organ function, no severe unrelated medical conditions, not be pregnant or breastfeeding, and agree to use contraception. Those on certain medications or with a history of other cancers or major surgery within two weeks are excluded.
What is being tested?
The trial tests Imatinib Mesylate's effects on sickle red blood cells by oral administration. It aims to reduce band 3 tyrosine phosphorylation levels and RBC-derived microparticles, potentially decreasing vaso-occlusive crises and acute chest syndrome over six months.
What are the potential side effects?
Possible side effects include digestive issues, liver problems, muscle cramps or pain, headache, dizziness, swelling around eyes or lower legs; difficulty breathing; weight gain; fatigue; nausea/vomiting; rash/skin reactions; anemia (low red blood cell count); infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly active and can carry out daily activities with little to no help.
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I have had at least 2 painful episodes in the last year due to blocked blood vessels that needed strong painkillers.
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I am between 18 and 25 years old.
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I have been diagnosed with sickle cell disease through specific blood tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not taken any prohibited medications like rifampin or carbamazepine in the last 14 days.
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I am not on a long-term blood transfusion plan.
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I am currently not taking any other cancer treatments.
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I have a long-term liver condition like hepatitis or cirrhosis.
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I do not have severe heart problems like recent heart failure or heart attack.
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I do not have severe diseases like uncontrolled diabetes or infections.
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I do not have any infections that are currently uncontrolled.
Select...
My family has a history of sudden cardiac death.
Select...
I don't have a history of heart rhythm problems or need medications that affect heart rhythm.
Select...
I am on a long-term blood transfusion plan.
Select...
I have never taken Imatinib for my condition.
Select...
I cannot take hydroxyurea because it lowers my blood cell counts too much.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline band 3 phosphorylation at 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline band 3 phosphorylation at 7 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Functional RBC analysis
Changes in Biochemical Effects - Band 3 Phosphorylation
Changes in Biochemical Effects - Microparticle Release
Secondary study objectives
Acute Chest Syndrome (ACS)
Assessment toxicities of imatinib in patients with sickle cell anemia (SCA)
Hospitalizations
+2 moreSide effects data
From 2022 Phase 2 trial • 54 Patients • NCT0302304626%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Hypotension
4%
Hypertension
4%
Intracranial hemorrhage
4%
Enterocolitis
2%
Peripheral motor neuropathy
2%
Small intestinal obstruction
2%
Lower gastrointestinal hemorrhage
2%
Fungemia
2%
Typhlitis
2%
Oropharyngeal pain
2%
Multi-organ failure
2%
Abdominal pain
2%
Hypoxia
2%
Kidney infection
2%
Edema limbs
2%
Sinus bradycardia
2%
Gastric hemorrhage
2%
Myocardial infarction
2%
Diarrhea
2%
Fibrinogen decreased
2%
Aspiration
2%
Atrial fibrillation
2%
Delirium
2%
Endophthalmitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Imatinib InterventionExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib
FDA approved
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Sickle Cell Disease (SCD) include hydroxyurea, voxelotor, and investigational therapies like imatinib mesylate. Hydroxyurea increases fetal hemoglobin (Hb F) levels, which reduces the polymerization of sickle hemoglobin (Hb S) and decreases vaso-occlusive events.
Voxelotor works by keeping Hb S in its oxygenated form, preventing polymerization and subsequent sickling of red blood cells. Imatinib mesylate, a tyrosine kinase inhibitor, is being studied for its potential to reduce band 3 tyrosine phosphorylation and RBC-derived microparticles, which may decrease the frequency of vaso-occlusive crises.
These treatments are crucial for SCD patients as they target the underlying mechanisms of the disease, reducing pain episodes, improving quality of life, and potentially preventing severe complications.
Advances in the management of sickle cell disease.
Advances in the management of sickle cell disease.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,035 Previous Clinical Trials
1,218,959 Total Patients Enrolled
Purdue UniversityOTHER
230 Previous Clinical Trials
70,994 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiOTHER
833 Previous Clinical Trials
6,564,945 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mostly active and can carry out daily activities with little to no help.I am taking other medications.I have not taken any prohibited medications like rifampin or carbamazepine in the last 14 days.I have had at least 2 painful episodes in the last year due to blocked blood vessels that needed strong painkillers.I am not on a long-term blood transfusion plan.I am currently not taking any other cancer treatments.My organs are functioning well.I have a long-term liver condition like hepatitis or cirrhosis.I had major surgery less than 2 weeks ago.I do not have severe heart problems like recent heart failure or heart attack.I do not have severe diseases like uncontrolled diabetes or infections.I am between 18 and 25 years old.I do not have any infections that are currently uncontrolled.You are unable to tolerate or have had a bad reaction to hydroxyurea.I have not taken certain medications like azole antifungals or clarithromycin in the last 7 days.My family has a history of sudden cardiac death.I don't have a history of heart rhythm problems or need medications that affect heart rhythm.I am on a long-term blood transfusion plan.I have never taken Imatinib for my condition.I have been cancer-free for less than 5 years and have no other cancer.I cannot take hydroxyurea because it lowers my blood cell counts too much.I have been diagnosed with sickle cell disease through specific blood tests.
Research Study Groups:
This trial has the following groups:- Group 1: Imatinib Intervention
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 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.
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