Clinical trial · Interventional
Bendamustine Study in Classical Hodgkin Lymphoma Patients Over 60 Treated by Prednisone, Vinblastine and Doxorubicin
A Prospective Phase II Study of Bendamustine in Patients Aged Over 60 Years With Classical Hodgkin Lymphoma Treated by Prednisone, Vinblastine and Doxorubicin
NCT02414568CI-TRIAL-00050205PVABcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classical Hodgkin Lymphoma | Classic Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PVAB regimen
- description
- 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
- interventionNames
- Drug: Bendamustine
- Drug: Prednisone
- Drug: Vinblastine
- Drug: Doxorubicin
Primary outcomes (1)
- 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
- timeFrame
- 3 years
- description
- 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
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 61 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 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: 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
References
Publications (1)
- DERIVEDGhesquieres 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