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Closed (no longer recruiting)Last updated: 2 February 2024

PCYC-1146: This phase I/II trial is evaluating a targeted therapy to treat children and adolescents diagnosed with chronic graft versus host diseasePhase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

Clinical summary

Summary

This trial has two parts.

In Part A, patients that are ≥1 to <12 years of age and have moderate or severe chronic graft versus host disease (cGVHD), will receive oral ibrutinib once daily to determine the Recommended Pediatric Equivalent Dose (RPED). Patients in Part A of the trial may continue receiving daily ibrutinib until the RPED is determined, at which time their dose may be adjusted to the RPED. Patients  ≥1 to <12 years of age (upper age limit is < 22 years)  and enrolled in Part B will receive ibrutinib at the RPED dose. Patients aged 12 and over will receive oral ibrutinib once daily at a 420mg dose.

Conditions

This trial is treating patients with chronic Graft Versus Host Disease (cGVHD).

Cancer

Blood Cancers Haematological

Age

People1 - 21

Phase

I/II

Trial Acronym

PCYC-1146

More information

Trial Identifiers

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Trial sponsor

Pharmacyclics LLC. & Janssen Research & Development, LLC.

Scientific Title

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

Eligibility

Inclusion

  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

Exclusion

  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)

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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