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Trial record 1 of 1 for:    NIVINIHO
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Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients With Classical Hodgkin Lymphoma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03580408
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

Brief Summary:

This study is a multicentric phase II open-label trial consisting of 6 cycles Nivolumab (2 weeks interval) followed by a PET-CT scan. The treatment will be allocated according to PET and CT scan responses. :

  • In case of CMR according to Lugano Classification (Cheson et al.2014, PET-CT based response), patients will receive 18 additional cycles of Nivolumab, according to CT-based response at Cycle 12.
  • In case of Partial Metabolic Response (PMR) or No Metabolic Response(NMR), according to Lugano Classification (Cheson et al.2014, PET-CT based response) patients will receive 12 to 18 cycles of Nivolumab combined with Vinblastin according to CT-based response at Cycle 12.
  • In case of progressive disease, according to Lugano Classification (Cheson et al.2014, PET-CT scan based response) patients will be considered in treatment failure.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Coexisting Medical Conditions Drug: Nivolumab Drug: Vinblastin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Phase II Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients Aged 61 Years And Older, With Classical Hodgkin Lymphoma And Coexisting Medical Conditions.
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2023


Arm Intervention/treatment
Experimental: Experimental

Induction treatment :Nivolumab will be given alone at 240 mg flat dose every 2 weeks (i.e. one cycle) Patients will be assessed after 3 months of therapy (after 6 injections of Nivolumab)

Consolidation treatment:

It depends on the induction evaluation by PET-CT and CT-scan (Lugano 2014 criteria) :

  • For patients achieving CMR according to Lugano Classification : treatment by nivolumab 240 mg every 2 weeks for 9 months.
  • Patients who reach PMR and NMR after 3 months (according to Lugano Classification) will be treated by the Nivolumab+Vinblastin regimen every 2 weeks for 9 additional months: Vinblastin(6 mg/m2 (IV) + Nivolumab 240 mg (IV)
  • In case of progressive disease , patients will be considered in treatment failure.
Drug: Nivolumab
240 mg

Drug: Vinblastin
6mg/m²




Primary Outcome Measures :
  1. Complete Metabolic Response (CMR) rate (Deauville scale 1-3) at the end of treatment [ Time Frame: 12 months ]
    by the Lugano classification 2014


Secondary Outcome Measures :
  1. Quantity of drug taken [ Time Frame: 12 months ]
  2. Number of Serious Adverse Event [ Time Frame: 12 months ]
  3. Progression-free survival (PFS) [ Time Frame: 5 years ]
  4. Event-free survival (EFS) [ Time Frame: 5 years ]
  5. Overall survival (OS) [ Time Frame: 5 years ]
  6. Complete Metabolic Response (CMR) rate [ Time Frame: 3 months ]
    by the Lugano classification 2014 at the end of induction treatment



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.


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Ages Eligible for Study:   61 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first diagnosis of classical Hodgkin lymphoma according to World Health Organization (WHO) criteria excluding nodular lymphocyte predominant subtype
  • Age 61 years or older
  • Unfit for poly chemotherapy because of co-morbidities evaluated by a Cumulative Illness Rating Scale (CIRS) score ≥6)
  • No previous treatment for Hodgkin lymphoma
  • Ann Arbor stages: I-IV
  • Baseline 18-fluoro-2-deoxy-D-glucose (18F-FDG) PET-CT (PET0) performed before any treatment with at least one hypermetabolic lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-3
  • minimum life expectancy of 3 months
  • covered by a social security system
  • Men who are sexually active with women with childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug and for at least 7 months after the last drug administration.

Exclusion Criteria:

  • Contra-indication to Nivolumab and /or Vinblastin
  • Subjects with active interstitial pneumonitis
  • Subjects with active infectious disease
  • Subjects with active, known or suspected autoimmune disease. Are permitted to enroll: subjects with vitiligo, type I 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.
  • Any serious active disease, severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment (according to the investigator's decision)
  • Any of the following abnormal laboratory values (unless due to underlying HL) :

    1. Calculated creatinine clearance < 30 mL/min (MDRD formula)
    2. aspartate transaminase (AST) or alanine transaminase (ALT) > 2.5 times the upper limit of normal (ULN)
    3. Serum total bilirubin > 30µmol/L
    4. Neutrophils<1 G/L or Platelets<50 G/L, (unless related to bone infiltration by lymphoma)
  • Any history of cancer evolution requiring therapy during the last 3 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if :

    1. Their disease was T1-T2a, N0, M0, with a Gleason score ≤ 7, and a prostate specific antigen (PSA) ≤ 10 ng/mL prior to initial therapy,
    2. They had definitive curative therapy (ie, prostatectomy or radiotherapy) ≥ 2 years before Day 1 of Cycle 1,
    3. At a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
  • Uncontrolled diabetes mellitus leading to impossibility to perform PET scan
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
  • Adult person under legal protection
  • Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
  • Subjects with know Human Immunodeficiency Virus (HIV) positivity
  • Subjects with known active hepatitis B (HB) infection (positive Ag HB s or positive DNA polymerase chain reaction (PCR) or positive antibody anti-HB c with lack of antibody against HBs) or active hepatitis C infection (patients with positive HCV serology are eligible only if PCR is negative for known hepatitis C virus (HCV RNA)
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration except for adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease.

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): NCT03580408


Contacts
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Contact: Chloé GOURC BERTHOD +334 72 66 93 33 chloe.gourc-berthod@lysarc.org

Locations
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Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Investigators
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Study Chair: Vincent RIBRAG Institut Gustave Roussy Cancer, Villejuif, France - LYSA
Study Chair: Julien LAZAROVICI Institut Gustave Roussy Cancer, Villejuif, France - LYSA
Study Chair: Marc ANDRE CHU Dinant Godinne, UCL Namur, Yvoir - Belgium - LYSA

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Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT03580408    
Other Study ID Numbers: NIVINIHO
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Lymphoma Academic Research Organisation:
Nivolumab
Lymphoma
Anti-PD1
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Nivolumab
Vinblastine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action