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

Sponsor
Melbourne Health
Study ID
NCT03146468
Phase
PHASE2
Status
Unknown

Conditions

  • Haematological Malignancy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab Injection — DRUG
    Human monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor

Study Details

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.

Key Dates

Start date
May 8, 2017
Status verified
Sep 2021
Primary completion
Mar 1, 2022
Completion
Mar 1, 2022

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab treatment arm
    Nivolumab injection 3mg/kg intravenously every 2 weeks

Primary Outcome Measure

Graft versus host disease [ Time Frame: 8 weeks ]

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