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

NCT02414568 | Completed Phase 2 DMC

• 1 other identifier: PVAB
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 40

Brief 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.

Conditions

Classical Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (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

  3 years

Secondary Outcomes (6)

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

  5 years

• Safety profile including immediate toxicities and non-tumor events

  5 years

• Progression-free survival

  5 years

• Disease-free survival

  5 years

• Overall survival

  5 years

Study Arms (1)

PVAB regimen

EXPERIMENTAL

Prednisone 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

Drug: Bendamustine; Drug: Prednisone; Drug: Vinblastine; Drug: Doxorubicin

Interventions

Bendamustine DRUG

Bendamustine 120 mg/m2 (IV) Day 1

Also known as: LEVACT

PVAB regimen

Prednisone DRUG

Prednisone 40 mg/m² PO

Also known as: CORTANCYL

PVAB regimen

Vinblastine DRUG

Vinblastine 6 mg/m² IV

Also known as: VELBE

PVAB regimen

Doxorubicin DRUG

Doxorubicin 40 mg/m² IV

Also known as: ADRIBLASTINE

PVAB regimen

Eligibility Criteria

• Age: 61 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Having previously signed a written informed consent
• The patient must be covered by a social security system, if applicable

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The Lymphoma Academic Research Organisation: lead

Study Sites (40)

A. Z. Sint-Jan

Bruges, 8000, Belgium

Location

Clinique Universitaire St Luc

Brussels, 1200, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

UCL Mont Godinne

Yvoir, 5530, Belgium

Location

CHU d'Amiens - Groupe Hospitalier Sud

Amiens, 80054, France

Location

Hôpital Jean Minjoz

Besançon, 25030, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

Location

CHRU de Brest - Hôpital Morvan

Brest, 29609, France

Location

CHU de Caen

Caen, 14000, France

Location

Médipôle de Savoie

Challes-les-Eaux, 73190, France

Location

CH Sud Francilien

Corbeil-Essonnes, 91106, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU Dijon - Hôpital d'Enfants

Dijon, 21000, France

Location

CHU de Grenoble - Hôpital Albert Michallon

Grenoble, 38043, France

Location

CH Départemental Vendée

La Roche-sur-Yon, 85925, France

Location

CH de Versailles

Le Chesnay, 78157, France

Location

CH du Mans

Le Mans, 72000, France

Location

CHRU de Lille

Lille, 59037, France

Location

CHU de Limoges

Limoges, 87042, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

CHR de Metz-Thionville - Hôpital de Mercy

Metz, 57085, France

Location

Hôpital Lapeyronie

Montpellier, 34295, France

Location

CH de Mulhouse

Mulhouse, 68070, France

Location

CHU de Nantes - Hôtel Dieu

Nantes, 44093, France

Location

CHRU de Nîmes

Nîmes, 30029, France

Location

Hôpital de la Pitié-Salpêtrière

Paris, 75013, France

Location

Hôpital Saint Louis

Paris, 75475, France

Location

Hôpital Necker

Paris, 75743, France

Location

CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

Pessac, 33604, France

Location

CHU Lyon Sud

Pierre-Bénite, 69310, France

Location

CHU Poitiers

Poitiers, 86000, France

Location

CH Rene Dubos

Pontoise, 95303, France

Location

Centre Hospitalier Annecy-Genevois - Site d'Annecy

Pringy, 74374, France

Location

CHU de Reims

Reims, 51092, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

CHU de Strasbourg

Strasbourg, 67098, France

Location

CHU de Tours - Hôpital Bretonneau

Tours, 37044, France

Location

CH de Valenciennes

Valenciennes, 59322, France

Location

CHU Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

• 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.

  PMID: 37979133 DERIVED

MeSH Terms

Interventions

Bendamustine Hydrochloride; Prednisone; Vinblastine; Doxorubicin

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Hervé Ghesquières, MD

  The Lymphoma Academic Research Organisation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 10, 2015
• Study Start: July 17, 2015
• Primary Completion: December 14, 2018
• Study Completion: November 10, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (36); BE (4)