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Tyrosine Kinase Inhibitor

Imatinib for Tuberculosis (IMPACT-TB Trial)

Phase 2
Waitlist Available
Led By Edmund K. Waller, MD, PhD, FACP
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult age between 18 years and 55 years
Body mass index (BMI) greater than 18.5 kg/m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 7, 14, 21, 28, 42
Awards & highlights

IMPACT-TB Trial Summary

This trial will study the safety and effects of imatinib when given with and without isoniazid and rifabutin. The results will help determine the dose of imatinib to be studied in a future trial as an adjunctive therapy for drug-sensitive tuberculosis.

IMPACT-TB Trial Eligibility Criteria

Inclusion Criteria

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

IMPACT-TB Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 7, 14, 21, 28, 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 7, 14, 21, 28, 42 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Grade 3 or 4 Adverse Events (AEs)
Frequency of Serious Adverse Events (SAEs)
Number of Myelomonocytic Cells in the Blood
Secondary outcome measures
Area Under the Curve (AUC) for Imatinib
Area Under the Curve (AUC) for Isoniazid
Area Under the Curve (AUC) for Rifabutin
+10 more

Side effects data

From 2022 Phase 3 trial • 330 Patients • NCT03112603
34%
Anaemia
21%
Pyrexia
20%
Hypertension
19%
Alanine aminotransferase increased
18%
Blood creatinine increased
16%
Diarrhoea
15%
Pneumonia
15%
Neutropenia
15%
Cough
15%
Fatigue
13%
Thrombocytopenia
12%
Nausea
12%
Gamma-glutamyltransferase increased
12%
Dyspnoea
12%
Aspartate aminotransferase increased
12%
Upper respiratory tract infection
12%
Platelet count decreased
12%
Arthralgia
11%
Back pain
10%
Headache
10%
Influenza
10%
Nasopharyngitis
10%
Hypertriglyceridaemia
10%
Myalgia
9%
Vomiting
9%
Blood cholesterol increased
9%
Hypokalaemia
8%
Constipation
8%
Oedema peripheral
8%
Conjunctivitis
8%
Insomnia
8%
Urinary tract infection
8%
Hypercholesterolaemia
8%
Hyperglycaemia
7%
Amylase increased
7%
Blood alkaline phosphatase increased
7%
Blood creatine phosphokinase increased
7%
Dry eye
7%
Hyperkalaemia
6%
Leukopenia
6%
Pain in extremity
6%
Lipase increased
5%
COVID-19
5%
BK virus infection
5%
Rhinorrhoea
5%
Fibrin D dimer increased
5%
Hyperuricaemia
5%
Cytomegalovirus infection reactivation
5%
Hypomagnesaemia
4%
Bronchitis
4%
Tremor
4%
Abdominal pain
3%
Lower respiratory tract infection
2%
Dyspepsia
2%
Febrile neutropenia
2%
Bronchopulmonary aspergillosis
2%
COVID-19 pneumonia
2%
Sepsis
2%
Pulmonary embolism
2%
Herpes zoster
2%
Osteonecrosis
2%
Pneumothorax
2%
Pneumonia bacterial
2%
Cataract
2%
Asthenia
2%
Hypophosphataemia
1%
Skin squamous cell carcinoma recurrent
1%
Ileus
1%
Enterococcal infection
1%
Depressed level of consciousness
1%
Erysipelas
1%
Haematemesis
1%
Syncope
1%
Measles
1%
Pseudomonal sepsis
1%
Angle closure glaucoma
1%
Meningitis viral
1%
Acute respiratory distress syndrome
1%
Pyelonephritis
1%
Pancreatitis acute
1%
Stomatitis
1%
Catheter site haemorrhage
1%
Generalised oedema
1%
Multiple organ dysfunction syndrome
1%
Bacteraemia
1%
Bacterial translocation
1%
Brain abscess
1%
Fungal infection
1%
Mycobacterial infection
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia cytomegaloviral
1%
Respiratory syncytial virus infection
1%
Respiratory tract infection
1%
Respiratory tract infection bacterial
1%
Respiratory tract infection fungal
1%
Septic shock
1%
Systemic infection
1%
Tracheitis
1%
Dehydration
1%
Squamous cell carcinoma
1%
Squamous cell carcinoma of skin
1%
Spinal cord compression
1%
Completed suicide
1%
Acute kidney injury
1%
Alveolar proteinosis
1%
Hypoxia
1%
Respiratory failure
1%
Tachypnoea
1%
Upper respiratory tract inflammation
1%
Toxic epidermal necrolysis
1%
Loss of personal independence in daily activities
1%
Deep vein thrombosis
1%
Cardiac failure congestive
1%
Gastrointestinal ulcer
1%
Melaena
1%
Oral candidiasis
1%
Pneumococcal infection
1%
Respiratory tract infection viral
1%
Post transplant lymphoproliferative disorder
1%
Epilepsy
1%
Haemorrhage intracranial
1%
Confusional state
1%
Organising pneumonia
1%
Pleuritic pain
1%
Pneumonitis
1%
Pulmonary oedema
1%
Hypotension
1%
Pruritus
1%
General physical health deterioration
1%
Escherichia sepsis
1%
Anal abscess
1%
Cytomegalovirus infection
1%
Lower respiratory tract infection fungal
1%
Meningitis cryptococcal
1%
Anastomotic complication
1%
Infusion related reaction
1%
Spinal compression fracture
1%
Cytomegalovirus test positive
1%
SARS-CoV-2 test positive
1%
White blood cell count decreased
1%
Decreased appetite
1%
Tendon disorder
1%
Basal cell carcinoma
1%
Renal impairment
1%
Vulvovaginal inflammation
1%
Atrial flutter
1%
Splenic haemorrhage
1%
Corneal erosion
1%
Corneal perforation
1%
Adenovirus reactivation
1%
Muscular weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib
Best Available Therapy
Ruxolitinib Cross-Over Period

IMPACT-TB Trial Design

9Treatment groups
Experimental Treatment
Group I: Imatinib (400 mg)Experimental Treatment1 Intervention
Participants will receive 400 mg imatinib daily for 28 days.
Group II: Imatinib (200 mg)Experimental Treatment1 Intervention
Participants will receive 200 mg imatinib daily for 28 days.
Group III: Imatinib (100 mg)Experimental Treatment1 Intervention
Participants will receive 100 mg imatinib daily for 28 days.
Group IV: Cohort 2b: Imatinib + Rifabutin + IsoniazidExperimental Treatment3 Interventions
Participants will receive isoniazid and rifabutin for 14 days, followed by 14 days of combination isoniazid, rifabutin, and imatinib. Imatinib dose will be determined after analyzing data from Cohort 1.
Group V: Cohort 2a: Imatinib + Rifabutin + IsoniazidExperimental Treatment3 Interventions
Participants will receive isoniazid and rifabutin for 14 days, followed by 14 days of combination isoniazid, rifabutin, and imatinib. Imatinib dose will be determined after analyzing data from Cohort 1.
Group VI: Cohort 1d: Imatinib (400 mg) + Rifabutin + IsoniazidExperimental Treatment3 Interventions
Participants will receive 400 mg imatinib for 14 days, followed by 14 days of imatinib together with rifabutin and isoniazid.
Group VII: Cohort 1c: Imatinib (200 mg) + Rifabutin + IsoniazidExperimental Treatment3 Interventions
Participants will receive 200 mg imatinib for 14 days, followed by 14 days of imatinib together with rifabutin and isoniazid.
Group VIII: Cohort 1b: Imatinib (100 mg) + Rifabutin + IsoniazidExperimental Treatment3 Interventions
Participants will receive 100 mg imatinib for 14 days, followed by 14 days of imatinib together with rifabutin and isoniazid.
Group IX: Cohort 1a: Imatinib (50 mg) + Rifabutin + IsoniazidExperimental Treatment3 Interventions
Participants will receive 50 mg imatinib for 14 days, followed by 14 days of imatinib together with rifabutin and isoniazid.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib
2011
Completed Phase 3
~3940
Rifabutin
2003
Completed Phase 4
~890
Isoniazid
2004
Completed Phase 4
~14050

Find a Location

Who is running the clinical trial?

Aurum InstituteOTHER
15 Previous Clinical Trials
12,679 Total Patients Enrolled
9 Trials studying Tuberculosis
8,862 Patients Enrolled for Tuberculosis
University of PennsylvaniaOTHER
1,992 Previous Clinical Trials
42,875,336 Total Patients Enrolled
1 Trials studying Tuberculosis
18,696 Patients Enrolled for Tuberculosis
University of FloridaOTHER
1,333 Previous Clinical Trials
714,567 Total Patients Enrolled
9 Trials studying Tuberculosis
2,754 Patients Enrolled for Tuberculosis

Frequently Asked Questions

~5 spots leftby Mar 2025