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

Primary Purpose

Haematological Malignancy

Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Nivolumab Injection
Sponsored by
Melbourne Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Haematological Malignancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Royal Melbourne Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nivolumab treatment arm

Arm Description

Nivolumab injection 3mg/kg intravenously every 2 weeks

Outcomes

Primary Outcome Measures

Graft versus host disease
Cumulative incidence of graft versus host disease
Graft versus host disease
Cumulative incidence of graft versus host disease
Graft versus host disease
Cumulative incidence of graft versus host disease

Secondary Outcome Measures

Overall response rate
Complete remission and partial remission
Overall response rate
Complete remission and partial remission
Overall response rate
Complete remission and partial remission
Overall response rate
Complete remission and partial remission

Full Information

First Posted
May 7, 2017
Last Updated
September 21, 2021
Sponsor
Melbourne Health
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1. Study Identification

Unique Protocol Identification Number
NCT03146468
Brief Title
Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation
Acronym
NIVALLO
Official Title
Pilot Study of the Tolerability of Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Haematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melbourne Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haematological Malignancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab treatment arm
Arm Type
Experimental
Arm Description
Nivolumab injection 3mg/kg intravenously every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Nivolumab Injection
Other Intervention Name(s)
Opdivo
Intervention Description
Human monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor
Primary Outcome Measure Information:
Title
Graft versus host disease
Description
Cumulative incidence of graft versus host disease
Time Frame
8 weeks
Title
Graft versus host disease
Description
Cumulative incidence of graft versus host disease
Time Frame
24 weeks
Title
Graft versus host disease
Description
Cumulative incidence of graft versus host disease
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Overall response rate
Description
Complete remission and partial remission
Time Frame
8 weeks
Title
Overall response rate
Description
Complete remission and partial remission
Time Frame
16 weeks
Title
Overall response rate
Description
Complete remission and partial remission
Time Frame
24 weeks
Title
Overall response rate
Description
Complete remission and partial remission
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ritchie, FRACP, PhD
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared by researchers outside of this clinical trial

Learn more about this trial

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

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