NCT02959944

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT02959944

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)

Summary

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

Eligibility

Key Inclusion Criteria:

* New onset moderate or severe cGVHD as defined by the 2014 National Institutes of Health (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

Key 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)

Disease(s) and\or Condition(s)

Chronic Graft Versus Host Disease

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: ibrutinib
- Description: Ibrutinib capsules administered orally daily
- Arm Group Labels: Ibrutinib + Prednisone
- Type: DRUG
- Name: Placebo
- Description: Placebo capsules administered orally daily
- Arm Group Labels: Placebo + Prednisone
- Type: DRUG
- Name: Prednisone
- Description: Prednisone administered daily
- Arm Group Labels: Ibrutinib + Prednisone, Placebo + Prednisone

Sponsor

Pharmacyclics LLC.