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

Haematological Malignancy Clinical Trial

— NIVALLO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03146468
• Other study ID #: RMH 2016.281
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 8, 2017
• Est. completion date: March 1, 2022

Study information

• Verified date: September 2021
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Haematological Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital	Parkville	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft versus host disease	Cumulative incidence of graft versus host disease	8 weeks
Primary	Graft versus host disease	Cumulative incidence of graft versus host disease	24 weeks
Primary	Graft versus host disease	Cumulative incidence of graft versus host disease	48 weeks
Secondary	Overall response rate	Complete remission and partial remission	8 weeks
Secondary	Overall response rate	Complete remission and partial remission	16 weeks
Secondary	Overall response rate	Complete remission and partial remission	24 weeks
Secondary	Overall response rate	Complete remission and partial remission	48 weeks