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Tyrosine Kinase Inhibitor

Phase 1 Nilotinib in Steroid Dependent/Refractory Chronic Graft Versus Host Disease

Phase 1
Waitlist Available
Led By David Miklos
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

PRIMARY OBJECTIVES: Determine the safety and tolerability of nilotinib in steroid dependent / refractory cGVHD. SECONDARY OBJECTIVES: Determine the clinical efficacy of nilotinib in steroid dependent / refractory cGVHD.

Eligible Conditions
  • Peripheral T-Cell Lymphoma
  • Graft Failure
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2014 Phase 3 trial • 267 Patients • NCT01275196
28%
Thrombocytopenia
27%
Leukopenia
23%
Platelet count decreased
22%
Lipase increased
21%
White blood cell count decreased
19%
Nasopharyngitis
19%
Eyelid oedema
14%
Anaemia
14%
Neutropenia
14%
Diarrhoea
13%
Hypophosphataemia
13%
Rash
12%
Alanine aminotransferase increased
12%
Neutrophil count decreased
11%
Haemoglobin decreased
11%
Pyrexia
11%
Vomiting
11%
Nausea
10%
Upper respiratory tract infection
10%
Hypokalaemia
9%
Blood creatine phosphokinase increased
8%
Hypertriglyceridaemia
8%
Blood phosphorus decreased
8%
Face oedema
7%
Aspartate aminotransferase increased
7%
Arthralgia
7%
Cough
6%
Myalgia
6%
Blood bilirubin increased
6%
Dizziness
5%
Influenza
4%
Hyperglycaemia
3%
Headache
3%
Hyperbilirubinaemia
2%
Abdominal pain upper
2%
Bilirubin conjugated increased
2%
Low density lipoprotein increased
2%
Apolipoprotein B increased
2%
Gamma-glutamyltransferase increased
2%
Hypercholesterolaemia
1%
Oesophageal squamous cell carcinoma
1%
Ovarian rupture
1%
Thrombocytosis
1%
Anal abscess
1%
Ankle fracture
1%
Blast cell count increased
1%
Intervertebral disc protrusion
1%
Cervix carcinoma stage 0
1%
Non-Hodgkin's lymphoma recurrent
1%
Cerebral haemorrhage
1%
Hydrothorax
1%
Thrombocytopenic purpura
1%
Bone marrow failure
1%
Granulocytopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imatinib 400 mg qd
Nilotinib 300 mg Bid

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.
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: NilotinibExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nilotinib
FDA approved

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,270 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,131 Total Patients Enrolled
David MiklosPrincipal InvestigatorStanford University
4 Previous Clinical Trials
10,128 Total Patients Enrolled
George ChenPrincipal InvestigatorStanford University
2 Previous Clinical Trials
156 Total Patients Enrolled
~2 spots leftby Jan 2026
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