Clinical Trial: Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Study of the Tolerability of Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Haematopoietic Stem Cell Transplantation

Brief Summary:

This is a prospective study of the safety and efficacy of nivolumab for the treatment of relapsed or residual haematological malignancies after allogeneic stem cell transplantation (alloSCT).

Eligible patients will receive nivolumab at a dose of 3mg/kg intravenously every 2 weeks. The primary objective is to evaluate the incidence, severity and treatment responsiveness of GVHD following nivolumab treatment post-alloSCT.

Detailed Summary:
Sponsor: Melbourne Health

Current Primary Outcome:

• Graft versus host disease [ Time Frame: 8 weeks ]
  Cumulative incidence of graft versus host disease
• Graft versus host disease [ Time Frame: 24 weeks ]
  Cumulative incidence of graft versus host disease
• Graft versus host disease [ Time Frame: 48 weeks ]
  Cumulative incidence of graft versus host disease

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Overall response rate [ Time Frame: 8 weeks ]
  Complete remission and partial remission
• Overall response rate [ Time Frame: 16 weeks ]
  Complete remission and partial remission
• Overall response rate [ Time Frame: 24 weeks ]
  Complete remission and partial remission
• Overall response rate [ Time Frame: 48 weeks ]
  Complete remission and partial remission

Original Secondary Outcome: Same as current

Information By: Melbourne Health

Dates:
Date Received: May 7, 2017
Date Started: May 8, 2017
Date Completion: June 1, 2020
Last Updated: May 7, 2017
Last Verified: May 2017