We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Nivallo
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03146468
Recruitment Status : Active, not recruiting
First Posted : May 10, 2017
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Melbourne Health

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Haematological Malignancy Drug: Nivolumab Injection Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Tolerability of Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Haematopoietic Stem Cell Transplantation
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Nivolumab treatment arm
Nivolumab injection 3mg/kg intravenously every 2 weeks
 Drug: Nivolumab Injection
Human monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor
Other Name: Opdivo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Graft versus host disease [ Time Frame: 8 weeks ]
    Cumulative incidence of graft versus host disease

  2. Graft versus host disease [ Time Frame: 24 weeks ]
    Cumulative incidence of graft versus host disease

  3. Graft versus host disease [ Time Frame: 48 weeks ]
    Cumulative incidence of graft versus host disease


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: 8 weeks ]
    Complete remission and partial remission

  2. Overall response rate [ Time Frame: 16 weeks ]
    Complete remission and partial remission

  3. Overall response rate [ Time Frame: 24 weeks ]
    Complete remission and partial remission

  4. Overall response rate [ Time Frame: 48 weeks ]
    Complete remission and partial remission


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146468


Locations
Layout table for location information
Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Investigators
Layout table for investigator information
Principal Investigator: David Ritchie, FRACP, PhD Melbourne Health
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT03146468    
Other Study ID Numbers: RMH 2016.281
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared by researchers outside of this clinical trial

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Nivolumab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action