Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old Patient

• Register: ClinicalTrials.gov
• Last refreshed on: 16 January 2023
• Main ID: NCT02467946
• Date of registration: 04/06/2015
• Prospective Registration: Yes
• Primary sponsor: Centre Antoine Lacassagne
• Public title: Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old Patient HALO
• Scientific title: 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
• Date of first enrolment: January 14, 2016
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02467946
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria:

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with the understanding that consent may be withdrawn by the patient at any time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.

Exclusion Criteria:

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.

o A 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



Age minimum: 60 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Clinical Efficacy

Safety

Intervention(s)

Drug: Adcetris-Levact

Primary Outcome(s)

toxicity analysis [Time Frame: up to 2.5 years]

Efficacy analysis [Time Frame: up to 2.5 years]

Secondary Outcome(s)

Progression Free Survival [Time Frame: 3 years]

Complete Response Rate [Time Frame: 2 years]

Secondary ID(s)

2013/24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Millennium: The Takeda Oncology Company