Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation
- Registration Number
- NCT03146468
- Lead Sponsor
- Melbourne Health
- 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 Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Prior allogeneic stem cell transplant for a haematological malignancy
- Confirmed relapse of haematological malignancy or persistent disease post-alloSCT
- Immunosuppression cessation for minimum of 2 weeks
- Life expectancy > 2 months
- ECOG performance status 0-2
- Greater than or equal to 30% CD3+ donor chimerism
- Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 40mL/min
- AST and ALT ≤ 3 times upper limit of normal
- Total bilirubin ≤ 1.5 times upper limit of normal (except patients with Gilbert Syndrome)
- Signed written informed consent
Exclusion Criteria
- Current evidence of any grade of GVHD
- Prior history of grade 2 or higher acute GVHD
- Moderate chronic GVHD within the previous 6 months or any prior history of severe chronic GVHD
- Active, known or suspected autoimmune disease (excluding vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger)
- Positive hepatitis B virus surface antigen
- Positive hepatitis C virus antibody
- Known human immunodeficiency virus infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nivolumab treatment arm Nivolumab Injection Nivolumab injection 3mg/kg intravenously every 2 weeks
- Primary Outcome Measures
Name Time Method Graft versus host disease 48 weeks Cumulative incidence of graft versus host disease
- Secondary Outcome Measures
Name Time Method Overall response rate 48 weeks Complete remission and partial remission
Trial Locations
- Locations (1)
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia