Bendamustine Study in Classical Hodgkin Lymphoma Patients Over 60 Treated by Prednisone, Vinblastine and Doxorubicin
NCT ID: NCT02414568
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2015-07-17
2020-11-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PVAB regimen
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
Bendamustine
Bendamustine 120 mg/m2 (IV) Day 1
Prednisone
Prednisone 40 mg/m² PO
Vinblastine
Vinblastine 6 mg/m² IV
Doxorubicin
Doxorubicin 40 mg/m² IV
Interventions
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Bendamustine
Bendamustine 120 mg/m2 (IV) Day 1
Prednisone
Prednisone 40 mg/m² PO
Vinblastine
Vinblastine 6 mg/m² IV
Doxorubicin
Doxorubicin 40 mg/m² IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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:
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 (i.e. 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
* 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
61 Years
ALL
No
Sponsors
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The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Principal Investigators
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Hervé Ghesquières, MD
Role: PRINCIPAL_INVESTIGATOR
The Lymphoma Academic Research Organisation
Locations
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A. Z. Sint-Jan
Bruges, , Belgium
Clinique Universitaire St Luc
Brussels, , Belgium
CHU de Liège
Liège, , Belgium
UCL Mont Godinne
Yvoir, , Belgium
CHU d'Amiens - Groupe Hospitalier Sud
Amiens, , France
Hôpital Jean Minjoz
Besançon, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
CHRU de Brest - Hôpital Morvan
Brest, , France
CHU de Caen
Caen, , France
Médipôle de Savoie
Challes-les-Eaux, , France
CH Sud Francilien
Corbeil-Essonnes, , France
Hôpital Henri Mondor
Créteil, , France
CHU Dijon - Hôpital d'Enfants
Dijon, , France
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, , France
CH Départemental Vendée
La Roche-sur-Yon, , France
CH de Versailles
Le Chesnay, , France
CH du Mans
Le Mans, , France
CHRU de Lille
Lille, , France
CHU de Limoges
Limoges, , France
Centre Léon Bérard
Lyon, , France
CHR de Metz-Thionville - Hôpital de Mercy
Metz, , France
Hôpital Lapeyronie
Montpellier, , France
CH de Mulhouse
Mulhouse, , France
CHU de Nantes - Hôtel Dieu
Nantes, , France
CHRU de Nîmes
Nîmes, , France
Hôpital de la Pitié-Salpêtrière
Paris, , France
Hôpital Saint Louis
Paris, , France
Hôpital Necker
Paris, , France
CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie
Pessac, , France
CHU Lyon Sud
Pierre-Bénite, , France
CHU Poitiers
Poitiers, , France
CH Rene Dubos
Pontoise, , France
Centre Hospitalier Annecy-Genevois - Site d'Annecy
Pringy, , France
CHU de Reims
Reims, , France
Hôpital Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
CHU de Strasbourg
Strasbourg, , France
CHU de Tours - Hôpital Bretonneau
Tours, , France
CH de Valenciennes
Valenciennes, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
Countries
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References
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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.
Other Identifiers
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PVAB
Identifier Type: -
Identifier Source: org_study_id
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