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Trial record 1 of 1 for:    NCT02959944
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Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Subjects With New Onset cGVHD (iNTEGRATE)

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ClinicalTrials.gov Identifier: NCT02959944
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.

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

Condition or disease Intervention/treatment Phase
Chronic Graft Versus Host Disease Drug: ibrutinib Drug: Placebo Drug: Prednisone Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD) (INTEGRATE)
Study Start Date : December 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: Ibrutinib
Ibrutinib in combination with prednisone
Drug: ibrutinib
Ibrutinib capsules administered orally daily
Other Names:
  • IMBRUVICA®
  • PCI-32765

Drug: Prednisone
Prednisone administered daily

Placebo Comparator: Placebo
Placebo in combination with prednisone
Drug: Placebo
Placebo capsules administered orally daily

Drug: Prednisone
Prednisone administered daily




Primary Outcome Measures :
  1. Response rate at 24 weeks [ Time Frame: Response will be defined by the NIH Consensus Development Project Criteria (2014) ]
    Response will be defined by the NIH Consensus Development Project Criteria (2014)


Secondary Outcome Measures :
  1. Proportion of subjects with steroid dose reduction at 24 weeks [ Time Frame: 24 weeks ]
  2. Withdrawal of all immunosuppressants [ Time Frame: Approximately 3 years after the first subject is randomized ]
  3. Overall survival (OS) from time of randomization until the time of death due to any cause [ Time Frame: Approximately 3 years after the first subject is randomized ]
  4. Duration of response (DOR) [ Time Frame: Approximately 3 years after the first subject is randomized ]
  5. Number of participants with adverse events as a measure of safety and tolerability of ibrutinib and prednisone versus placebo in combination with prednisone [ Time Frame: Up to 30 days after the last participating subject discontinues study drug ]
  6. Lee cGVHD symptom scale improvement [ Time Frame: 24 Weeks ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959944


Contacts
Contact: PCYC1140 Study Team 1140@pcyc.com

  Show 76 Study Locations
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Investigators
Study Director: Justin Wahlstrom, MD Pharmacyclics LLC.

Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02959944     History of Changes
Other Study ID Numbers: PCYC-1140-IM
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

Keywords provided by Pharmacyclics LLC.:
chronic graft versus host disease
PCYC1140
PCYC1140IM
1140
Ibrutinib
GVHD
Steroid dependent
refractory
chronic
PCI32765
IMBRUVICA
Pharmacyclics
PCYC
graft versus host disease
immunology
new onset graft versus host disease
INTEGRATE
Corticosteroids
prednisone

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents