Clinical Trial 22114

• Overview

  Study Title:

  Randomized Phase II study of Belumosudil vs. Placebo for Preemptive Treatment of Chronic Graft vs. Host Disease

  Objective:

  Primary: Determine whether pre-emptive initiation of belumosudil prevents the need to start subsequent systemic immune suppressive therapy for cGVHD. Secondary: 1. Determine whether pre-emptive belumosudil therapy improves event-free survival (composite endpoint inclusive of death, malignancy relapse, or need to start subsequent systemic immune suppressive therapy - beyond randomized preemptive therapy - for cGVHD). 2. Assess the difference in overall survival between treatment groups. 3. Assess the difference in relapse between treatment groups.

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  Belumosudil (); KD025 (Belumosudil); Placebo ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • At least one diagnostic or distinctive cGVHD manifestation(s) with a clinical diagnosis of cGVHD, but patients do not need to meet NIH criteria for cGVHD.
  • If eye involvement only, cGVHD must be confirmed on exam by an ophthalmologist or optometrist.
  • No new immune suppressive therapy added within preceding 2 weeks prior to study enrollment for any indication.
  • Age 18 and older.
  • Karnofsky performance score greater than or equal to 70.
  • Able to take oral medications.
  • Signed informed consent.
  • ALT and AST less than or equal to 3 × ULN.
  • Total bilirubin less than or equal to 1.5 × ULN.
  • Glomerular filtration rate (GFR) greater than or equal to 30 mL/min/1.73 m2.
  • Female subjects of childbearing potential have a negative serum or urine pregnancy test at screening. Females of childbearing potential are defined as sexually mature females without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, females who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.
  • Sexually active females of childbearing potential enrolled in the study must agree to use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug.
  • For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug.
  • No evidence of active malignancy.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Any systemic immune suppressive treatment for cGVHD (topical or local therapies are allowed).
  • Plan to start systemic immune suppressive therapy for cGVHD or increase steroid dose within 14 days after planned start of study medication.
  • 0.25 mg/kg/day or higher prednisone dose at time of screening.
  • History of non-compliance that in the investigator's opinion would interfere with study participation.
  • Uncontrolled psychiatric illness.
  • Female subject who is pregnant or breast feeding.
  • Previous therapy with belumosudil.
  • Known allergy/sensitivity to belumosudil or any other ROCK2 inhibitor.
  • Treatment with another investigational agent within 28 days (or 5 half-lives, whichever is greater) of enrollment.

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