New combo therapy shows promise for older hodgkin lymphoma patients
NCT ID NCT01476410
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tested a combination of the targeted drug brentuximab vedotin with standard chemotherapy (AVD) in 49 older adults with untreated Hodgkin lymphoma. The goal was to see how many patients achieved complete remission. The approach aims to improve outcomes by targeting cancer cells more precisely while using chemotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (AVD chemotherapy)
- What this could lead to
- If successful, this combination could offer a more effective treatment option for older adults with Hodgkin lymphoma, potentially leading to higher remission rates.
- What could go wrong
- This is a small phase II trial with only 49 participants, so results may not apply to all patients. Side effects from chemotherapy and the targeted drug can be serious, and long-term outcomes are not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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49 people
The number who actually took part.
- Start date
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Nov 2011
- Finished
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May 2020
- 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
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60 years and older
- 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: * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care * Previously untreated classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte depleted, lymphocyte-rich, and not otherwise specified \[NOS\]); nodular lymphocyte predominant Hodgkin lymphoma is not eligible * Stage II, III, and IV disease by Ann Arbor classification * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 * Patients must have bi-dimensional measurable disease documented in the lymphoma baseline tumor assessment form within 30 days prior to registration (at least 1.5 cm); patients with non-measurable disease in addition to measurable disease must have been assessed within 60 days prior to registration * Patients must have a bone marrow biopsy (bilateral preferred, unilateral acceptable) within 60 days prior to registration * Patients must have a multi gated acquisition scan (MUGA) or echocardiogram within 60 days prior to study registration and the ejection fraction must be \>= 45% * Absolute neutrophil count (ANC) \> 1000/mm\^3 * Platelet count \> 75,000/mm\^3 * Creatinine \< 2.5 mg/dl * Bilirubin \< 3.0 mg/dl * Patients with documented marrow involvement by lymphoma at the time of registration are not required to meet the above hematologic parameters * Patients must not have received prior chemotherapy or radiation therapy for the treatment of Hodgkin lymphoma * Both females and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug * Patients must sign the informed consent form before registration Exclusion Criteria: * Previous treatment with brentuximab vedotin or any other prior anti-CD30-based antibody therapy * History of another primary malignancy that has not been in remission for at least 3 years; (the following are exempt from the 3-year limit: early stage \[stage I or II\] breast cancer treated with surgery and radiation +/- hormones \[without adjuvant chemotherapy\], non-melanoma skin cancer, fully excised melanoma in situ \[stage 0\], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou test \[PAP smear\]) * Known cerebral/meningeal disease * Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 1 week prior to first dose * Patients with hepatitis B surface antigen (HBsAg) positive hepatitis B virus (HBV) infection; patients with prior history of hepatitis B infection, but immune, with only Immunoglobulin G (IgG) hepatitis core antibody + (HBcAb +) must receive anti-viral prophylaxis (e.g., lamivudine 100mg orally \[po\] daily) for at least 1 week prior to cycle 1 and throughout induction and continuation therapy and for at least 6 months after the last brentuximab vedotin dose; in addition, consultation with a hepatologist is recommended * Patients with a known hypersensitivity to any excipient contained in the drug formulation * Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent
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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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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Memorial Sloan- Kettering Cancer Center
New York, New York, 10065, United States
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NorthwesternU
Chicago, Illinois, 60611, United States
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Stanford University Medical Center
Stanford, California, 94305, United States
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Tufts Medical Center
Boston, Massachusetts, 02111, United States
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University of Chicago
Chicago, Illinois, 60637, United States
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University of Nebraska Medical Center
Omaha, Nebraska, 68198-7835, United States
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Other studies related to the condition(s) this trial covers.
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