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Clinical EfficacyPhase 1/2HALONCT02467946

Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old Patient

A Phase 1/2 study testing Adcetris-Levact in people with Clinical Efficacy and Safety, run by Centre Antoine Lacassagne at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Treatment outcome with ABVD in elderly patients remains inferior to adults. Moreover, Bleomycin-induced lung toxicity in the elderly has been reported as high as 46%. For these reasons, questions arise whether ABVD could be still considered the standard treatment in HL patients aged > than 60. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Clinical Efficacy, Safety
What is being tested?
Adcetris-Levact
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
14 Jan 2016to 6 Apr 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification. All Hasenclever IPS prognostic groups accepted
  • Stages IIB to IV B
  • Age 60-80 years included
  • Patient not previously treated
  • ECOG ≤ 2
  • Patient with adequate organ function:
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  • 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)
  • 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)
  • 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.
  • Patient affiliated with a health insurance system.

Who cannot join

  • Patients aged less than 60 years.
  • 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.
  • Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML.
  • Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication.
  • Symptomatic sensory or motor peripheral neuropathy.
  • 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
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  • Chemotherapy, biologics, and/or other treatment with immunotherapy not completed at least 4 weeks prior to first dose of study drug.
  • Patient who had major surgery less than 30 days before start of treatment
  • Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose.
  • Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of BV.
  • 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)
  • 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.
  • Patients with uncompensated diabetes mellitus and fasting glucose levels over 180 mg/dl.
  • 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
  • Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
  • People particularly vulnerable including:
  • Person deprived of liberty
  • Adult patient entitled to protection of law

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Antoine Lacassagne

    Nice, 06000

Other trials in France

About this study

Official 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

Treatment outcome with ABVD in elderly patients remains inferior to adults. Moreover, Bleomycin-induced lung toxicity in the elderly has been reported as high as 46%. For these reasons, questions arise whether ABVD could be still considered the standard treatment in HL patients aged > than 60. Regimens containing other alkylators such as CHOP proved even superior to ABVD, with a 3-y PFS of 67%. Frontline treatment of advanced-stage HL with Brentuximab Vedotin (BV) in association with AVD (Doxorubicin, Vinblastine, Dacarbazine) proved very active in a pioneer study, reporting the preliminary results of a phase 1 multicentre trial, in which the percentage of patients achieving CR was as high as 92%. For all these reason the investigators decided to test the association of an alkylator with an innovative mechanism of action and a very safe toxicity profile in the elderly such as Bendamustine (Be) with BV in untreated elderly HL patients.

The combination of BV and Be, investigated in this study, might represent an innovative treatment alternative for HL patients older than 60 years of age, especially for those of them in whom ABVD chemotherapy, the current standard front-line treatment, is not suitable. However, even when ABVD is given as upfront treatment for elderly HL patients, it is associated with substantial dose reduction, treatment delay, toxicity, and treatment-related mortality, with treatment outcomes remaining much inferior to those obtained in younger patients. This drug association is expected to be safe, well-tolerated and to demonstrate higher efficiency compared with ABVD. In this setting, it is expected that this therapy could be offered to the large majority of elderly patients with a full treatment completion reached in up to 80% of these patients.

Thus, the aim of this study will be to assess safety and efficacy of the above association.

Being tested
Adcetris-Levact

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adcetris-LevactDrug

    Also called Bendamustine, Brentuximab Vedotin

    Association of Adcetris (1.2 mg/kg intravenously every 3 weeks) with Levact (90 mg/m2/day intravenously for 2 days every 3 weeks) during at least 6 cycles.

Study groups in NCT02467946
Study groupRoleWhat they receive
Adcetris-Levact (BV-Be) AssociationExperimentalAdcetris® (BV) : 1.2 mg/kg intravenously every 3 weeks Levact® (Be): 90 mg/m2/day intravenously for 2 days every 3 weeks. Up to 6 cycles
Receives: Drug: Adcetris-Levact

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. toxicity analysis

    To evaluate the tolerability and toxicity of Adcetris-Levact (BV-Be) association.

    Measured: up to 2.5 years

  2. Efficacy analysis

    To evaluate the efficacy in terms of Response Rate after treatment completion of Adcetris-Levact (BV-Be) association.

    Measured: up to 2.5 years

Secondary outcomes (2)

  1. Progression Free Survival

    • To evaluate the efficacy in terms of:
    • Progression Free Survival at 3 years
    • Event Free Survival at 3 years
    • Overall Survival at 3 years

    Measured: 3 years

  2. Complete Response Rate

    • To evaluate the efficacy in terms of Complete Response Rate after two cycles of Adcetris-Levact (BV-Be) association

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2015 (estimated)
  2. Study start14 Jan 2016
  3. Primary completion6 Apr 2022
  4. Study completion6 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02467946
Sponsor's protocol ID
2013/24
Acronym
HALO
Status last verified
Aug 2026
First submitted
4 Jun 2015
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Gallamini A, Viviani S, Rapezzi D, Patti C, Feugier P, Rambaldi A, Bijou F, Borra A, Borel C, Pace-Loscos T, Schiappa R, Chauvie S, Debaigt C, Guidetti A, Humbert O, De Colella JS. Long-term results of brentuximab vedotin and bendamustine for first-line treatment of Hodgkin lymphoma in the elderly (HALO trial). Br J Haematol. 2026 Aug 26. doi: 10.1111/bjh.70763. Online ahead of print.

    PubMed 42644287

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Adcetris-Levact in people with Clinical Efficacy and Safety, run by Centre Antoine Lacassagne at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

toxicity analysis (time frame: up to 2.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02467946, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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