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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monthly over 7 months

Awards & highlights

IMPACT Trial Summary

This trial will test the effects of imatinib on sickle red blood cells. Imatinib will be given to patients following established guidelines, and the patients' red blood cells will be examined for changes. The trial will last six 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.Check my eligibility

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.See study design

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.

IMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

IMPACT Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline band 3 phosphorylation at 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Functional RBC analysis

Changes in Biochemical Effects - Band 3 Phosphorylation

Changes in Biochemical Effects - Microparticle Release

Secondary outcome measures

Acute Chest Syndrome (ACS)

Assessment toxicities of imatinib in patients with sickle cell anemia (SCA)

Hospitalizations

+2 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046

26%

Febrile neutropenia

17%

Sepsis

Mucositis oral

Upper gastrointestinal hemorrhage

Intracranial hemorrhage

Hypotension

Hypertension

Enterocolitis

Atrial fibrillation

Lower gastrointestinal hemorrhage

Delirium

Oropharyngeal pain

Gastric hemorrhage

Abdominal pain

Diarrhea

Fungemia

Typhlitis

Myocardial infarction

Fibrinogen decreased

Endophthalmitis

Multi-organ failure

Kidney infection

Peripheral motor neuropathy

Hypoxia

Sinus bradycardia

Edema limbs

Small intestinal obstruction

Aspiration

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy)

IMPACT 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

0 / 5Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

982,962 Total Patients Enrolled

Purdue UniversityOTHER

224 Previous Clinical Trials

72,744 Total Patients Enrolled

Children's Hospital Medical Center, CincinnatiOTHER

815 Previous Clinical Trials

6,531,571 Total Patients Enrolled

Media Library

Imatinib Mesylate (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03997903 — Phase 1 & 2

Sickle Cell Disease Research Study Groups: Imatinib Intervention

Sickle Cell Disease Clinical Trial 2023: Imatinib Mesylate Highlights & Side Effects. Trial Name: NCT03997903 — Phase 1 & 2

Imatinib Mesylate (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03997903 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase of this clinical trial still open to participants?

"Correct. According to the information available on clinicaltrials.gov, this medical experiment was posted on February 26th 2020 and is currently recruiting participants across 2 locations with a total of 20 needed individuals."

Answered by AI

What medical problems does Imatinib Mesylate typically address?

"Imatinib Mesylate is a common form of treatment for patients with newly diagnosed acute lymphoblastic leukaemia. Additionally, Imatinib Mesylate may be employed to help those suffering from refractory ALL, muscular dystrophy, and metastatic dermatofibrosarcoma protuberans."

Answered by AI

Is it possible to join this medical experiment?

"This medical trial is accepting 20 anemic sickle cell patients aged 18 to 25. To qualify, individuals must have experienced two episodes of vaso-occlusive pain in the past year and meet certain parameters for bone marrow, renal, liver and cardiac functioning. Further consent from either a legal guardian or patient will be required prior to qualification confirmation."

Answered by AI

What are the overarching goals of this experiment?

"This clinical study seeks to measure the biochemical alteration of Band 3 phosphorylation over a 7-month period. Secondary objectives involve assessing imatinib's toxicity on SCA patients, recording vaso-occlusive episodes through pain scales or Wong Baker Faces scale and documenting opioid consumption for both oral and parenteral administration."

Answered by AI

How many individuals are engaged in this experiment?

"Affirmative. Clinicaltrials.gov records suggest that recruitment is ongoing for this experiment, which was initially posted on February 26th 2020 and last modified on July 28th 2022. The researchers are intending to enroll 20 individuals at 2 different clinical sites."

Answered by AI

Are persons aged 25 and over eligible to participate in this trial?

"The parameters set out for this medical study require that participants are aged 18 to 25. Meanwhile, there are 140 separate trials available for minors and 130 studies suited to seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Imatinib for Pain in Sickle Cell Anemia

Seethal Jacob, MD, MS 2020. "Imatinib for Pain in Sickle Cell Anemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03997903.

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