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

Melbourne Health

Status and phase: Unknown; Phase 2

Conditions: Haematological Malignancy

Treatments: Drug: Nivolumab Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03146468

RMH 2016.281

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Nivolumab treatment arm

Experimental group

Description:

Nivolumab injection 3mg/kg intravenously every 2 weeks

Treatment:

Drug: Nivolumab Injection