Can a new drug pair tame hodgkin lymphoma in older patients?
NCT ID NCT02467946
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests whether combining two drugs, brentuximab vedotin (Adcetris) and bendamustine (Levact), can safely and effectively treat Hodgkin lymphoma in people aged 60 to 80 who have not had prior treatment. The standard therapy, ABVD, often causes lung damage in older adults, so researchers are looking for a gentler alternative. Participants receive the drug combination intravenously every three weeks for at least six cycles. The study measures how well the treatment shrinks tumors and tracks side effects, along with long-term outcomes like survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of two chemotherapy drugs: brentuximab vedotin (Adcetris) and bendamustine (Levact), given intravenously every three weeks for at least six cycles.
- What this could lead to
- If it works, this combination could offer older adults with Hodgkin lymphoma a safer and more effective first treatment than the current standard, with fewer lung side effects.
- What could go wrong
- This is an early-phase trial with only 60 participants, so the combination may not prove more effective or safe enough. The drugs can still cause serious side effects, including low blood counts and infections.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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60 people
The number who actually took part.
- Started
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Jan 2016
- Finished
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Apr 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
60 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Antoine Lacassagne
Nice, 06000, France
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