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Classical Hodgkin LymphomaPhase 2PVABNCT02414568

Bendamustine Study in Classical Hodgkin Lymphoma Patients Over 60 Treated by Prednisone, Vinblastine and Doxorubicin

A Phase 2 study testing Bendamustine, Prednisone and Vinblastine in people with Classical Hodgkin Lymphoma, run by The Lymphoma Academic Research Organisation at 40 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This study evaluates bendamustine in patients aged over 60 years with classical Hodgkin Lymphoma treated by prednisone, vinblastine and doxorubicin. 90 patients will be enrolled in this study. Read more about this study

Who is it for?
Ages 61 years and older
Conditions the study is for
Classical Hodgkin Lymphoma
What is being tested?
Bendamustine, Prednisone and Vinblastine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
40 sitesin 2 countries
Study dates
17 Jul 2015to 10 Nov 2020
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

  • Patient with a first diagnosis of classical Hodgkin lymphoma according to the World Health Organization (WHO) criteria excluding nodular lymphocyte predominant subtype
  • Age of 61 years or older
  • No previous treatment for Hodgkin lymphoma
  • Ann Arbor stages:
  • II with mediastinum/thorax ≥0.33 or extranodal localization and with B symptoms
  • Or III
Show all 17Show fewer
  • Or IV
  • Baseline 18-FluoroDeoxyGlucose (FDG) PET scan (PET0) performed before any treatment with at least one hypermetabolic lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate cardio-pulmonary function with Left Ventricular Ejection Fraction (LVEF) ≥ 50%
  • Adequate renal function with creatinine clearance ≥ 40 mL/mn (MDRD formula)
  • For patients aged 70 years old and more, a Mini Nutritional Assessment (MNA) ≥ 17
  • A minimum life expectancy of 3 months
  • Negative Human Immunodeficiency Virus, Hepatitis B (HB) Virus (anti-HB c negativity) and Hepatitis C Virus serologies tests ≤ 30 days before inclusion (except after vaccination)
  • Having previously signed a written informed consent
  • The patient must be covered by a social security system, if applicable
  • Men patient must agree to use an adequate method of contraception during the study treatment and until 6 months after the end of the study treatment.

Who cannot join

  • Any other type of lymphoma including nodular lymphocyte predominant subtype
  • Any history of treated Hodgkin lymphoma
  • Contra-indication to any drug contained in the chemotherapy regimens
  • Any serious active disease (according to the investigator's decision)
  • Poor hepatic function (total bilirubin level > 30 μmol/L or transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma
  • Poor bone marrow reserve as defined by leukocytes < 2 G/L or platelets < 100 G/L, unless related to bone marrow infiltration
Show all 13Show fewer
  • Any history of cancer 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 they fulfil all the followings:
  • 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 (i.e. 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
  • Severe metabolic disease interfering with normal application of protocol treatment as 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 under tutelage

Trial locations and contacts

40 sites in 2 countries.

40 sites in 2 countries

France36 sites

  • CHU d'Amiens - Groupe Hospitalier Sud

    Amiens, 80054

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • CHRU de Brest - Hôpital Morvan

    Brest, 29609

  • CHU de Caen

    Caen, 14000

  • Médipôle de Savoie

    Challes-les-Eaux, 73190

  • CH Sud Francilien

    Corbeil-Essonnes, 91106

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU Dijon - Hôpital d'Enfants

    Dijon, 21000

  • CHU de Grenoble - Hôpital Albert Michallon

    Grenoble, 38043

  • CH Départemental Vendée

    La Roche-sur-Yon, 85925

  • CH de Versailles

    Le Chesnay, 78157

  • CH du Mans

    Le Mans, 72000

  • CHRU de Lille

    Lille, 59037

  • CHU de Limoges

    Limoges, 87042

  • Centre Léon Bérard

    Lyon, 69373

  • CHR de Metz-Thionville - Hôpital de Mercy

    Metz, 57085

  • Hôpital Lapeyronie

    Montpellier, 34295

  • CH de Mulhouse

    Mulhouse, 68070

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093

  • CHRU de Nîmes

    Nîmes, 30029

  • Hôpital de la Pitié-Salpêtrière

    Paris, 75013

  • Hôpital Saint Louis

    Paris, 75475

  • Hôpital Necker

    Paris, 75743

  • CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

    Pessac, 33604

  • CHU Lyon Sud

    Pierre-Bénite, 69310

  • CHU Poitiers

    Poitiers, 86000

  • CH Rene Dubos

    Pontoise, 95303

  • Centre Hospitalier Annecy-Genevois - Site d'Annecy

    Pringy, 74374

  • CHU de Reims

    Reims, 51092

  • Hôpital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • CHU de Strasbourg

    Strasbourg, 67098

  • CHU de Tours - Hôpital Bretonneau

    Tours, 37044

  • CH de Valenciennes

    Valenciennes, 59322

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Belgium4 sites

  • A. Z. Sint-Jan

    Bruges, 8000

  • Clinique Universitaire St Luc

    Brussels, 1200

  • CHU de Liège

    Liège, 4000

  • UCL Mont Godinne

    Yvoir, 5530

Other trials in Belgium

About this study

Official title: A Prospective Phase II Study of Bendamustine in Patients Aged Over 60 Years With Classical Hodgkin Lymphoma Treated by Prednisone, Vinblastine and Doxorubicin

This study evaluates bendamustine in patients aged over 60 years with classical Hodgkin Lymphoma treated by prednisone, vinblastine and doxorubicin. 90 patients will be enrolled in this study.

Read the detailed description

The usual treatment for Hodgkin lymphoma is chemotherapy Adriamycin (also known as doxorubicin) + Bleomycin + Vinblastine + Dacarbazine (ABVD). Studies have shown that patients aged over 60 years have a lower tolerance and efficiency during this treatment than younger patients. There are particular pulmonary toxicities with bleomycin included in the ABVD treatment.

Alternative treatment strategies have been proposed removing bleomycin in the Prednisone + Vinblastine + Adriamycin/Doxorubicin +Gemcitabine (PVAG) protocol evaluated in more than 60 patients. Compared to ABVD treatment, PVAG treatment presented a more favorable toxicity profile. The quality of response between the two treatments is substantially equal.

Bendamustine was evaluated in four studies in patients with Hodgkin lymphoma in relapse and showed higher efficacy than gemcitabine with an acceptable toxicity profile.

In this study, the Sponsor and the coordinating investigator propose to replace dacarbazine in the standard ABVD protocol by bendamustine and to stop using bleomycin.

The main objective of this study is to evaluate the safety and efficacy of bendamustine in patients treated with prednisone, vinblastine and doxorubicin. This is the PVAB treatment with which LYSARC and the coordinating investigator expect better tolerability and quality response.

Being tested
Bendamustine, Prednisone, Vinblastine, Doxorubicin

What participants receive

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

  • BendamustineDrug

    Also called LEVACT

    Bendamustine 120 mg/m2 (IV) Day 1

  • PrednisoneDrug

    Also called CORTANCYL

    Prednisone 40 mg/m² PO

  • VinblastineDrug

    Also called VELBE

    Vinblastine 6 mg/m² IV

  • DoxorubicinDrug

    Also called ADRIBLASTINE

    Doxorubicin 40 mg/m² IV

Study groups in NCT02414568
Study groupRoleWhat they receive
PVAB regimenExperimentalPrednisone 40 mg/m2 (PO) Days 1-5 ; Vinblastine 6 mg/m2 (IV) Day 1 ; Doxorubicin 40 mg/m2 (IV) Day 1 ; Bendamustine 120 mg/m2 (IV) Day 1
Receives: Drug: Bendamustine; Drug: Prednisone; Drug: Vinblastine; Drug: Doxorubicin

What is being measured

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

  1. Complete Metabolic Response rate at the end of study treatment (after 6 cycles of study treatment or at premature treatment discontinuation) defined according to Lugano Classification

    Complete Metabolic Response rate at the end of study treatment (after 6 cycles of study treatment or at premature treatment discontinuation) defined according to Lugano Classification

    Measured: 3 years

Secondary outcomes (6)

  1. Feasibility of the protocol, with adequate protocol adherence (adequate dose without excessive delay)

    Feasibility of the protocol, with adequate protocol adherence (adequate dose without excessive delay)

    Measured: 5 years

  2. Safety profile including immediate toxicities and non-tumor events

    Safety profile including immediate toxicities and non-tumor events

    Measured: 5 years

  3. Progression-free survival

    Progression-free survival

    Measured: 5 years

  4. Disease-free survival

    Disease-free survival

    Measured: 5 years

  5. Overall survival

    Overall survival

    Measured: 5 years

  6. Geriatric assessment program

    7 Quality of Life Questionnaires (QLQ)

    Measured: 5 years

Timeline

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

  1. First posted10 Apr 2015 (estimated)
  2. Study start17 Jul 2015
  3. Primary completion14 Dec 2018
  4. Study completion10 Nov 2020

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02414568
Sponsor's protocol ID
PVAB
Acronym
PVAB
Status last verified
Feb 2021
First submitted
30 Mar 2015
Last updated
21 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ghesquieres H, Krzisch D, Nicolas-Virelizier E, Kanoun S, Gac AC, Guidez S, Touati M, Laribi K, Morschhauser F, Bonnet C, Waultier-Rascalou A, Orsini-Piocelle F, Andre M, Fournier M, Morand F, Berriolo-Riedinger A, Burroni B, Damotte D, Traverse-Glehen A, Quittet P, Casasnovas O. The phase 2 LYSA study of prednisone, vinblastine, doxorubicin, and bendamustine for untreated Hodgkin lymphoma in older patients. Blood. 2024 Mar 14;143(11):983-995. doi: 10.1182/blood.2023021564.

    PubMed 37979133

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine, Prednisone and Vinblastine in people with Classical Hodgkin Lymphoma, run by The Lymphoma Academic Research Organisation at 40 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 17 inclusion and 13 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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 rate at the end of study treatment (after 6 cycles of study treatment or at premature treatment discontinuation) defined according to Lugano Classification (time frame: 3 years). 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 NCT02414568, 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 21 Feb 2021.

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