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Trial record 37 of 308 for:    IBRUTINIB

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

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ClinicalTrials.gov Identifier: NCT03790332
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.

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

Condition or disease Intervention/treatment Phase
Chronic Graft Versus Host Disease Drug: Ibrutinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : September 9, 2021
Estimated Study Completion Date : April 24, 2026


Arm Intervention/treatment
Experimental: Phase 1/2

Part A: Subjects ≥1 to <12 years of age with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, will receive oral ibrutinib once daily to determine Recommended Pediatric Equivalent Dose (RPED).

Part A Continuation: Subjects participating in Part A may continue receiving daily ibrutinib until the RPED is determined, at which time their dose may be adjusted to the RPED.

Part B: Subjects ≥1 to <12 years of age( upper age limit is < 22 years) with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy or with newly diagnosed moderate or severe cGVHD will be dosed at the RPED. Subjects ≥12 will be given 420mg orally ibrutinib once daily.

Drug: Ibrutinib
Ibrutinib capsule, tablet, or suspension administered orally once daily
Other Names:
  • IMBRUVICA®
  • PCI-32765




Primary Outcome Measures :
  1. Part A- PK (measured by AUC) will be reported descriptively [ Time Frame: Approximately 24 months ]
  2. Part B- PK (measured by AUC) will be reported descriptively [ Time Frame: Approximately 7 years ]
  3. Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Approximately 7 years ]

Secondary Outcome Measures :
  1. Part A- Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Approximately 24 months ]
  2. Part A- Pharmacodynamic effects as measured by in vitro BTK occupancy will be reported descriptively [ Time Frame: Approximately 24 months ]
  3. Part A continuation cohort and Part B-Response rate at 24 weeks [ Time Frame: Approximately 6 months after last subject in enrolled ]
  4. Part A continuation cohort and Part B- Duration of response (DOR) [ Time Frame: Up to 48 weeks ]
  5. Part A continuation cohort and Part B-Overall survival (OS) [ Time Frame: Approximately 5 years after last subject enrolled ]
  6. Part A continuation cohort and Part B-Late Effects Surveillance [ Time Frame: Up to 5 years post enrollment ]
  7. Growth Parameter height in meters will be reported descriptively [ Time Frame: Up to 5 years post enrollment ]
    Subjects will be monitored for growth and development

  8. Growth Parameter weight in kilograms will be reported descriptively. [ Time Frame: Up to 5 years post enrollment ]
    Subjects will be monitored for growth and development

  9. Available immune reconstitution laboratory parameters will be reported descriptively [ Time Frame: Up to 5 years post enrollment ]
    Subjects will be monitored for immune reconstitution

  10. Late effects (Adverse events suspected to be related to treatment) will be quantified and reported descriptively [ Time Frame: Up to 5 years post enrollment ]


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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT03790332


Contacts
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Contact: Alina Smith 408-215-3442 asmith@pcyc.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Mary Suarez    626-218-5795    masuarez@coh.org   
Contact: Ahmed Tahoun    626-218-4350 ext 84350    atahoun@coh.org   
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Mehrzad Milburn    858-966-8155    mmilburn@rchsd.org   
United States, Colorado
Children's Hospital Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Shalini Shenoy    314-454-6018    ShaliniShenoy@wustl.edu   
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Elana Smilow    551-996-5673    Elana.Smilow@Hackensackmeridian.org   
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Susan Prockop       prockops@mskcc.org   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105-2729
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Lori Jarrett    206-667-2063    ljarrett@fredhutch.org   
Australia, Victoria
The Royal Children's Hospital Recruiting
Parkville, Victoria, Australia, 3052
Canada, Quebec
CHU Sainte-Justine Recruiting
Montréal, Quebec, Canada, H3T1C5
Contact: Henrique Bittencourt       henrique.bittencourt.hsj@ssss.gouv.qc.ca   
Contact: Anthony Gallego       anthony.gallego@recherche-ste-justine.qc.ca   
France
CHU Nantes - Hopital Enfant Adolescent Recruiting
Nantes, France, 44093
Hôpital Robert-Debré Ap-Hp Recruiting
Paris, France, 75019
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Investigators
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Study Director: Justin Wahlstrom, MD Pharmacyclics LLC.

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Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT03790332     History of Changes
Other Study ID Numbers: PCYC-1146-IM
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pharmacyclics LLC.:
Imbruvica
Ibrutinib
PCI32765
cGVHD
chronic graft versus host disease
PCYC1146IM
Pediatric
GVHD
chronic
1146
Pharmacyclics
PCYC
Immunology
graft versus host disease
corticosteroids
prednisone
PCYC1146
refractory
new onset graft versus host disease
refractory graft versus host disease
moderate cGVHD
severe cGVHD
moderate chronic graft versus host disease
severe chronic graft versus host disease

Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases