Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation
NCT ID: NCT03146468
Last Updated: 2021-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
14 participants
INTERVENTIONAL
2017-05-08
2022-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nivolumab treatment arm
Nivolumab injection 3mg/kg intravenously every 2 weeks
Nivolumab Injection
Human monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor
Interventions
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Nivolumab Injection
Human monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Melbourne Health
OTHER
Responsible Party
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Principal Investigators
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David Ritchie, FRACP, PhD
Role: PRINCIPAL_INVESTIGATOR
Melbourne Health
Locations
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Royal Melbourne Hospital
Parkville, Victoria, Australia
Countries
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Other Identifiers
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RMH 2016.281
Identifier Type: -
Identifier Source: org_study_id
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