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RecruitingLast updated: 26 February 2024

ROCKnrol-1: This study is evaluating how safe and effective Belumosudil in combination with corticosteroids is in people aged 12 years and over with newly diagnosed chronic Graft Versus Host disease (cGVHD)A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease (cGVHD)

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms.

In the Experimental Arm, participants will receive Belumosudil in combination with oral corticosteroids (either Prednisone or Prednisolone). Belumosudil will be administered as 200mg oral tablets once daily.

In the Placebo Comparator Arm, participants will receive an oral placebo tablet once daily in combination with oral corticosteroids (either Prednisone or Prednisolone).

Conditions

This trial is treating patients with newly diagnosed, moderate to severe, chronic Graft Versus Host disease

Cancer

Blood Cancers Haematological

Age

People12+

Phase

III

Trial Acronym

ROCKnrol-1

More information

Trial Identifiers

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Trial sponsor

Sanofi

Scientific Title

A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease (cGVHD)

Eligibility

Inclusion

  • Patients must be at least 12 years of age inclusive, at the time of signing the informed consent
  • Participants who have undergone allogenic HCT with newly diagnosed moderate to severe cGVHD according to NIH consensus diagnosis and staging criteria (2014)
  • Participants who require systemic treatment with corticosteroids for cGVHD
  • Participants who have not received any prior systemic treatment for cGVHD (including ECP)
  • If participants are receiving other immunosuppressive agents for the prophylaxis or treatment of acute GVHD, the dose should be under the threshold pre-defined in protocol
  • Body weight ≥ 40kg
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Participants or their legally authorized representative must be capable of giving signed informed consent

Exclusion

Participants are excluded from the study if any of the following criteria apply:

Medical conditions

  • Histological relapse of the underlying disease after most recent allogeneic HCT
  • Post-transplant lymphoproliferative disease within 4 weeks prior to randomization
  • Female participants who are pregnant or breastfeeding
  • Unable to tolerate a prednisone equivalent dose of corticosteroids ≥ 1 mg/kg/day Prior/concomitant therapy
  • Participant has had previous exposure to belumosudil.
  • Received any previous systemic treatment for cGVHD with the following exception: Corticosteroids for cGVHD received within 7 days prior to the planned administration of IMP only if in the interest of participant.

Prior/concurrent clinical study experience

  • Received any investigational agents, or any investigational device or procedure, or prohibited therapy for this study within 28 days or 5 elimination half-lives prior to randomization, whichever is longer Diagnostic assessments
  • Karnofsky (if aged ≥16 years)/Lansky (if aged <16 years) Performance Score of < 60
  • Platelets <50 x 109/L. Platelet transfusion is not allowed within 3 days before the screening hematological test
  • Absolute neutrophil count (ANC) <1.0 x 109/L. The use of granulocyte-colony stimulating factor (G-CSF) is not allowed to reach this level during screening
  • Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m2 using the MDRD-4 variable formula (if aged ≥18 years) or using the Bedside Schwartz formula (if aged <18 years)
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 x ULN without liver cGVHD (or >5 × ULN if due to cGVHD with liver cGVHD)
  • Total bilirubin >1.5 × (ULN) (>3 × ULN if Gilbert syndrome)
  • Participant has forced expiratory volume in 1 second (FEV1) of predicted ≤39% or has lung score of 3 according to NIH consensus diagnostic and staging criteria (2014)
  • History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease or coronary artery disease)
  • Known history of human immunodeficiency virus (HIV)
  • Active viral disease including hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Active uncontrolled cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of infection worsening are present according to Investigator's judgement
  • Diagnosed or treated for another malignancy other than the underlying disease allogeneic HCT was indicated for, within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy
  • Unable to swallow tablets
  • Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures

Inclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • 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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