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

• Status: Completed
• Trial end date: 2020-11-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Lymphoma Academic Research Organisation
• Treatments: Bendamustine Hydrochloride; Doxorubicin; Liposomal doxorubicin; Prednisone; Vinblastine

Criteria

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