Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:1 - 21
Updated:3/10/2019
Start Date:November 19, 2018
End Date:April 24, 2026
Contact:Alina Smith
Email:asmith@pcyc.com
Phone:408-215-3442

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Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus
Host Disease (cGVHD)


Key Eligibility:

Inclusion Criteria:

1. Part A: Subjects with moderate or severe cGVHD after failure of 1 or more lines of
systemic therapy

2. Part B: Subjects with moderate or severe cGVHD after failure of 1 or more lines of
systemic therapy, or subjects with new onset moderate or severe cGVHD and in need of
systemic immunosuppression

3. History of allogeneic stem cell transplantation

4. Age

- Part A: ≥1 to <12 years of age at the time of enrollment

- Part B: ≥1 to <22 years of age at the time of enrollment

5. Karnofsky or Lansky (subjects <16 years of age) performance status ≥60

Key Eligibility:

Exclusion Criteria:

1. Presence of single organ genito-urinary involvement as the only manifestation of cGVHD

2. Received an investigational agent within 28 days before enrollment.

3. Received donor lymphocyte infusion (DLI) within 56 days before enrollment

4. Progressive underlying malignant disease or active post-transplant lymphoproliferative
disease

5. Any uncontrolled infection or active infection requiring ongoing systemic treatment

6. Known bleeding disorders

7. Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
We found this trial at
4
sites
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Memphis, TN
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Duarte, California 91010
Phone: 626-218-5795
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Duarte, CA
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Phone: 551-996-5673
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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