Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Subjects With New Onset cGVHD



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:12 - Any
Updated:2/17/2019
Start Date:December 2016
End Date:March 2020
Contact:PCYC1140 Study Team
Email:1140@pcyc.com

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Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD) (INTEGRATE)

To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects
with newly diagnosed moderate to severe cGVHD.


Inclusion Criteria:

- New onset moderate or severe cGVHD as defined by the 2014 NIH Consensus Development
Project Criteria

- Need for systemic treatment with corticosteroids for cGVHD

- No previous systemic treatment for cGVHD (including extracorporeal photopheresis
[ECP])

- Participants may be receiving other immunosuppressants for the prophylaxis or
treatment of acute GVHD but if the subject is receiving prednisone for prophylaxis or
treatment of acute GVHD it must be at or below 0.5 mg/kg/d

- Age ≥12 years old

- Karnofsky or Lansky (subjects <16 years) performance status ≥60

Exclusion Criteria:

- Received any previous systemic treatment for cGVHD with the exception of
corticosteroids administered for cGVHD within the 72 hours prior to signing the
informed consent form.

- Inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cGVHD

- Any uncontrolled infection or active infection requiring ongoing systemic treatment

- Progressive underlying malignant disease or any post-transplant lymphoproliferative
disease

- Known bleeding disorders

- Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
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4100 John R
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740 South Limestone Street
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Miami, Florida 33124
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116th St and Broadway
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60 Crittenden Blvd # 70
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1100 Fairview Avenue North
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Bronx, New York 10461
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