Randomized phase III study of a treatment driven by early PET response compared to a treatment not monitored by early PET in patients with Ann Arbor Stage III-IV or high risk IIB Hodgkin lymphoma - AHL2011

Phase 1

• Conditions: Hodgkin Lymphoma not previously treated; MedDRA version: 14.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864

• Registration Number: EUCTR2010-022844-19-BE
• Lead Sponsor: CHU de Dijon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-26
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 810

Inclusion Criteria

- Patient with a first diagnosis of classical Hodgkin lymphoma according to WHO criteria excluding nodular lymphocyte predominant subtype
- Age of 16 to 60 years
- No previous treatment for Hodgkin lymphoma
- Ann Arbor stages:
IIB with mediastinum/thorax =0.33 or extra nodal localization
III
IV
- Baseline 18-FDG PET scan (PET0) performed before any treatment with at least one hypermetabolic lesion
- ECOG performance status < 3

Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Pregnant or lactating women
• Men and women of childbearing potential not practicing an adequate method of contraception during the study treatment and at least 3 months after the last study drug administration
• Any history of cancer or cancer treatment during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
• Uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen or presence of anti HBs antibody without detectable anti HBc antibody.
• HIV, HCV or HTLV serology positivity
• Abnormal liver (bilirubin > 2,5 N) function unless abnormalities are due to Hodgkin lymphoma
• Abnormal renal (Creatinin > 150 µmol/L) function unless abnormalities are due to Hodgkin lymphoma
• Leukopenia < 2 G/L or thrombopenia <100 G/L unless abnormalities are due to Hodgkin lymphoma
• Severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment:
oLEVF<50%
oRespiratory insufficiency prohibiting bleomycin use
oUncontrolled diabetes mellitus leading to impossibility to perform PET scan
• Impossibility to perform a baseline PET (PET0) before randomization and treatment beginning

Study & Design

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