A phase 1/2 clinical trial to assess safety and efficacy of a new treatment for Hodgkin lymphoma's disease combining Adcetris¿ and Levact¿ in Old patients
- Conditions
- Hodgkin LymphomaMedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003320-51-IT
- Lead Sponsor
- CENTRE ANTOINE LACASSAGNE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
1.Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification. All Hasenclever
IPS prognostic groups accepted
2.Stages IIB to IV B
3.Age 60-80 years included
4.Patient not previously treated
5.ECOG = 2
6.Patient with adequate organ function:
•Absolute neutrophil count (ANC) = 1.5 x 109/L
•Haemoglobin = 9 g/dL
•Platelets (PTL) = 100 x 109/L
•AST - ALAT = 2.5x ULN
•Bilirubin = 1.5 x ULN
•Creatinine < 150 µmol/l (or 1.7 mg/dl)
7.Male patients, even if surgically sterilized, (i.e., status post vasectomy) and women of childbearing potential agree to practice
effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to
completely abstain from heterosexual intercourse.
•Contraception as described above is not a requirement if the female patient’s postmenopausal status is documented (has had no
menstrual period for at least 12 consecutive months)
8.Information delivered to patient and voluntary written informed consent must be given before performance of any study-related
procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time
without prejudice to future medical care.
9.Patient affiliated with a health insurance system.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
1.Patients aged less than 60 years.
2.Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another
malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are
not excluded if they have undergone complete resection.
3.Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML.
4.Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication.
5.Symptomatic sensory or motor peripheral neuropathy.
6.Concurrent use of other investigational agents. In case of previous participation to a Clinical trial, a period of 30 days will be
observed after the end of the previous Clinical Trial and before the inclusion in HALO study
7.Chemotherapy, biologics, and/or other treatment with immunotherapy not completed at least 4 weeks prior to first dose of study
drug.
8.Patient who had major surgery less than 30 days before start of treatment
9.Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug
dose.
10.Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of BV.
11.Patient presenting an uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen
or presence of anti HBc antibody without detectable anti HBs antibody or HIV or HCV serology positivity. In case of HBc positive
serology, a PCR could be performed in order to determine viral load. Patients with viral load defined as negative could be
included.
oA prophylactic treatment will be strongly recommended (see HALO Study protocol, paragraph 6.2.3, page 36)
12.Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions,
or laboratory abnormalities that would interfere, in the judgment of the investigator and/or sponsor, with the ability to comply with
the study protocol.
13.Patients with uncompensated diabetes mellitus and fasting glucose levels over 180 mg/dl.
14.Known history of any of the following cardiovascular conditions
•Myocardial infarction within 2 years of enrollment
•New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 12)
•Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina,
or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
15.Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
16.People particularly vulnerable including:
•Person deprived of liberty
•Adult patient entitled to protection of law
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Phase 1:<br>To evaluate the tolerability and toxicity of Be-BV association.<br>Phase 2:<br>To evaluate the efficacy in terms of Response Rate after treatment completion of Be-BV association.;Secondary Objective: ¿ To evaluate the efficacy in terms of:<br>Progression Free Survival at 3 years<br>Event Free Survival at 3 years<br>Overall Survival at 3 years<br>¿ To evaluate the efficacy in terms of Complete Response Rate after<br>two Be-BV cycles of Be-BV association<br>¿ To evaluate the feasibility of the treatment;Primary end point(s): Phase 1:<br>Evaluation of frequency and grades of toxicity using the NCI CTCAE v4.03 classification<br>Phase 2:<br>Response Rate after treatment completion using modified IHP criteria with the five-point scale Deauville criteria as interpretation<br>Key for end of treatment PET scan.;Timepoint(s) of evaluation of this end point: 2 years and six months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ¿Rate at 3 years and median of<br>Progression Free Survival<br>¿Rate at 3 years and median of Event Free Survival<br>¿Rate at 3 years and median of Overall Survival<br>¿Control disease rate after two Be-BV cycles by using percentage of PET negative after two Be-BV cycles.<br>¿Prevalence of patient receiving the whole treatment courses (6 cycles)<br>;Timepoint(s) of evaluation of this end point: 3 years