Overview

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

Status:
Active, not recruiting
Trial end date:
2022-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Melbourne Health
Treatments:
Antibodies, Monoclonal
Nivolumab
Criteria
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