Study of bendamustine in patients aged over 60 years with classical Hodgkin lymphoma treated by prednisone, vinblastine and doxorubici

Phase 1

• Conditions: first diagnosis of classical Hodgkin lymphoma according to WHO criteria excluding nodular lymphocyte predominant subtype; MedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001002-17-BE
• Lead Sponsor: YSARC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-03
• Study Completion: 2020-11-10
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients must satisfy all following criteria to be enrolled in the study:
• Patient with a first diagnosis of classical Hodgkin lymphoma according to 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-FDG PET scan (PET0) performed before any treatment with at least one hypermetabolic lesion
• ECOG performance status 0-2
• Adequate cardio-pulmonary function with 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 HIV, HBV (anti-HBc negativity) and HCV 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

Presence of any of the following will exclude a patient from enrollment:
• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified