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Trial record 11 of 1333 for:    Hematologic neoplasm

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

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ClinicalTrials.gov Identifier: NCT03146468
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Melbourne Health

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
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 : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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




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



Information from the National Library of Medicine

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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

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


Contacts
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Contact: David Ritchie, FRACP, PhD +61 3 93422520 david.ritchie@mh.org.au
Contact: Eric Wong, FRACP +61 3 93427000 eric.wong@mh.org.au

Locations
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Australia, Victoria
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: David Ritchie, FRACP, PhD    +61 3 93422520    david.ritchie@mh.org.au   
Contact: Eric Wong, FRACP    +61 3 93427000    eric.wong@mh.org.au   
Principal Investigator: David Ritchie, FRACP, PhD         
Principal Investigator: Eric Wong, FRACP         
Sponsors and Collaborators
Melbourne Health
Investigators
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Principal Investigator: David Ritchie, FRACP, PhD Melbourne Health

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Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT03146468     History of Changes
Other Study ID Numbers: RMH 2016.281
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
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

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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:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents