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Hodgkin LymphomaPhase 2NCT03580408

Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients With Classical Hodgkin Lymphoma

A Phase 2 study testing Nivolumab and Vinblastin in people with Hodgkin Lymphoma and Coexisting Medical Conditions, run by The Lymphoma Academic Research Organisation at 51 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 61 years and older
What is being tested?
Nivolumab and Vinblastin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
51 sitesin 2 countries
Study dates
31 Aug 2018to 12 Aug 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 61 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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) :
Show all 21Show fewer
  • Calculated creatinine clearance < 30 mL/min (MDRD formula)
  • aspartate transaminase (AST) or alanine transaminase (ALT) > 2.5 times the upper limit of normal (ULN)
  • Serum total bilirubin > 30µmol/L
  • 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 :
  • 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,
  • They had definitive curative therapy (ie, prostatectomy or radiotherapy) ≥ 2 years before Day 1 of Cycle 1,
  • 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.

Trial locations and contacts

51 sites in 2 countries.

51 sites in 2 countries

France42 sites

  • CHU d'Amiens

    Amiens

  • CH d'Avignon - Hôpital Henri Duffaut

    Avignon

  • CH Côte Basque

    Bayonne

  • CHU de Besançon - Hôpital Jean Minjoz

    Besançon

  • Institut Bergonié - Bordeaux

    Bordeaux

  • Institut d'Hématologie de Basse Normandie - CHU Côte de Nacre

    Caen

  • CH Métropole Savoie

    Chambéry

  • CHU de Clermont Ferrand

    Clermont-Ferrand

  • CH Sud Francilien de Corbeil

    Corbeil-Essonnes

  • APHP-Hôpital Henri Mondor

    Créteil

  • CHU de Dijon - Hôpital le Bocage

    Dijon

  • CHU de Grenoble

    Grenoble

  • CHD de Vendée

    La Roche-sur-Yon

  • CH La Rochelle

    La Rochelle

  • CH du Mans

    Le Mans

  • CH Saint Vincent de Paul

    Lille

  • CHRU de LILLE - Claude Huriez

    Lille

  • CHU de Limoges

    Limoges

  • Centre Leon Berard

    Lyon

  • Institut Paoli Calmette

    Marseille

  • CHRU de Metz-Thionville

    Metz

  • CHU de Montpellier - Saint Eloi

    Montpellier

  • CHU de Nantes - Hôtel Dieu

    Nantes

  • CHU de Nîmes - Caremeau

    Nîmes

  • APHP - Hopital Necker

    Paris

  • APHP - Hôpital de la Pitié Salpetrière

    Paris

  • APHP - Hôpital Saint Louis

    Paris

  • Centre François Magendie - Hôpital du Haut Lévêque

    Pessac

  • CHU Lyon Sud

    Pierre-Bénite

  • CHU de Poitiers - Hôpital de La Milétrie

    Poitiers

  • Ch Rene Dubos

    Pontoise

  • Centre Hospitalier Annecy-Genevois - Site d'Annecy

    Pringy

  • CHU Robert Debré

    Reims

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes

  • CH de Roubaix

    Roubaix

  • Centre Henri Becquerel

    Rouen

  • CH de Saint Brieuc

    Saint-Brieuc

  • CHRU de Strasbourg

    Strasbourg, 67100

  • IUCT Toulouse

    Toulouse

  • CHU Bretonneau

    Tours

  • CHU Brabois

    Vandœuvre-lès-Nancy

  • Institut Gustave Roussy

    Villejuif

Other trials in France

Belgium9 sites

  • ZNA Stuivenberg

    Antwerp

  • Az Sint Jan

    Bruges

  • Clinique Universitaire Saint LUC

    Brussels

  • Institut Jules Bordet

    Brussels

  • Hopital Jolimont

    Haine-Saint-Paul

  • Az Groeninge

    Kortrijk

  • CHU de Liege

    Liège

  • CHU Dinant Godinne

    Yvoir

  • CHU UCL Namur

    Yvoir

Other trials in Belgium

About this study

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.

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.
Being tested
Nivolumab, Vinblastin
Keywords
Nivolumab, Lymphoma, Anti-PD1
Medical subject headings
Hodgkin Disease, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03580408
Study groupRoleWhat they receive
ExperimentalExperimentalInduction 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.
Receives: Drug: Nivolumab; Drug: Vinblastin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Metabolic Response (CMR) rate (Deauville scale 1-3) at the end of treatment

    by the Lugano classification 2014

    Measured: 12 months

Secondary outcomes (6)

  1. Quantity of drug taken

    Measured: 12 months

  2. Number of Serious Adverse Event

    Measured: 12 months

  3. Progression-free survival (PFS)

    Measured: 5 years

  4. Event-free survival (EFS)

    Measured: 5 years

  5. Overall survival (OS)

    Measured: 5 years

  6. Complete Metabolic Response (CMR) rate

    by the Lugano classification 2014 at the end of induction treatment

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2018
  2. Study start31 Aug 2018
  3. Primary completion19 Feb 2021
  4. Study completion12 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03580408
Sponsor's protocol ID
NIVINIHO
Status last verified
Aug 2022
First submitted
26 Jun 2018
Last updated
19 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lazarovici J, Amorim S, Bouabdallah K, Fournier M, Guidez S, Molina L, Morschhauser F, Delapierre B, Gastinne T, Laribi K, Launay V, Slama B, Belmecheri N, Casasnovas RO, Corby A, Durot E, Feugier P, Nicolas-Virelizie E, Sibon D, Berriolo-Riedinger A, Edeline V, Borght TV, Damotte D, Traverse-Glehen A, Ribrag V, Andre M. Nivolumab with or without vinblastine for first-line treatment of elderly patients with Hodgkin lymphoma and coexisting medical conditions: the Niviniho phase II Lysa study. Haematologica. 2026 May 28. doi: 10.3324/haematol.2025.300166. Online ahead of print.

    PubMed 42206423

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Vinblastin in people with Hodgkin Lymphoma and Coexisting Medical Conditions, run by The Lymphoma Academic Research Organisation at 51 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Metabolic Response (CMR) rate (Deauville scale 1-3) at the end of treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03580408, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.

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