Safety and Efficacy of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation (REACH2)

Official Title

A Phase III Randomized Open-label Multi-center Study of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation

Summary:

To evaluate the safety and efficacy of ruxolitinib compared to Best Available Therapy in patients with corticosteroid-refractory acute graft vs. host disease after allogeneic stem cell transplantation

Trial Description

Primary Outcome Measures :

  • Overall Response Rate (ORR)

Secondary Outcome Measures :

  • Durable Overall Response Rate
  • ORR
  • Duration of response (DOR)
  • Cumulative steroid dose
  • Overall Survival (OS)
  • Event-free survival
  • Failure-Free survival (FFS)
  • Non Relapse Mortality (NRM)
  • Malignancy Relapse/Progression (MR)
  • Incidence of chronic Graft versus Host Disease (cGvHD)
  • Pharmacokinetic (PK) parameter: Plasma concentration at peak (CMax) after single dose and at steady state of ruxolitinib in corticosteroid refractory acute GvHD patients
  • Exposure-efficacy relationship of ruxolitinib in corticosteroid refractory aGvHD
  • Patient Reported Outcomes (PROs): Change in Functional Assesment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) from baseline
  • Patient Reported Outcomes (PROs): Change in EuroQol-5D (EQ-5D) from baseline
  • Pharmacokinetic (PK) parameter: Area Under the Curve (AUC) after single dose and at steady state of ruxolitinib in corticosteroid refractory acute GvHD patients
  • AUC from time zero to the last measurable concentration sampling time and from time zero to infinity, and Accumulation ratio (Racc). Ruxolitinib after a single dose and at steady state. AUC at end of a dosing interval (AUC tau) at steady state.
  • Pharmacokinetic (PK) parameter: total body clearance of ruxolitinib from the plasma after single dose and at steady state of ruxolitinib in corticosteroid refractory acute GvHD patients
  • Pharmacokinetic (PK) parameter: apparent volume of distribution during terminal phase after single dose and at steady state of ruxolitinib in corticosteroid refractory acute GvHD patients

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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