We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Subjects With New Onset cGVHD (iNTEGRATE)

This study is currently recruiting participants.
Verified November 2017 by Pharmacyclics LLC.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02959944
First Posted: November 9, 2016
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.
  Purpose
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

Condition Intervention Phase
Chronic Graft Versus Host Disease Drug: ibrutinib Drug: Placebo Drug: Prednisone Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Pharmacyclics LLC.:

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


Secondary Outcome Measures:
  • Proportion of subjects with steroid dose reduction at 24 weeks [ Time Frame: 24 weeks ]
  • Withdrawal of all immunosuppressants at 48 weeks [ Time Frame: 48 weeks ]
  • 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 ]
  • Response rate at 48 weeks [ Time Frame: up to 48 weeks ]
  • 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 ]

Estimated Enrollment: 186
Study Start Date: December 2016
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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])
  • May be receiving other immunosuppressants for the prophylaxis or treatment of acute GVHD but the doses of these medications must have been stable for at least 2 weeks prior to Screening
  • Age ≥12 years old
  • Karnofsky or Lansky (subjects <16 years) performance status ≥60

Exclusion Criteria:

  • Received any previous systemic treatment for cGVHD
  • 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)
  Contacts and Locations
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 68 Study Locations
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Investigators
Study Director: Lori Styles, MD Pharmacyclics LLC.
  More Information

Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02959944     History of Changes
Other Study ID Numbers: PCYC-1140-IM
First Submitted: October 25, 2016
First Posted: November 9, 2016
Last Update Posted: November 17, 2017
Last Verified: November 2017

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