New drug cocktail shows promise for tough lymphomas
NCT ID NCT01657331
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of two drugs, brentuximab vedotin and bendamustine, in 65 patients with Hodgkin lymphoma or anaplastic large cell lymphoma that had come back or didn't respond to earlier treatments. The goal was to find the safest dose and see how well the drugs worked together. The trial has been completed, and results may help doctors treat these hard-to-manage lymphomas.
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 and bendamustine
- What this could lead to
- If successful, this combination could offer a new treatment option for patients whose lymphoma has returned or not responded to prior therapy.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. Side effects from the drug combination could be significant.
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
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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65 people
The number who actually took part.
- Started
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Jul 2012
- Finished
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Jun 2018
- 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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18 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: * Histologically confirmed relapsed or refractory HL or ALCL. * Documented CD30+ expression from either original diagnosis or a tumor biopsy in the relapsed setting. * For patients with HL, subjects are eligible after failure or having declined autologous stem cell transplant or at least two prior multi-agent chemotherapy regimens if they are not autologous stem cell transplant candidates. For patients with ALCL, subjects are eligible after failure of at least one prior multi-agent chemotherapy regimen and if they are not eligible for or have declined autologous stem cell transplant. * Must have received first line chemotherapy. No upper limit for the number of prior therapies. * Patients with prior autologous or allogeneic stem cell transplant are eligible as long as they meet all other criteria. * Measurable or evaluable disease, as defined in 2008 Revised Response Criteria for Malignant Lymphoma(33) * Age \> or = 18 years * ECOG performance status 0,1 or 2 * Patient's must have adequate organ and marrow function as defined below * Absolute neutrophil count \> or = 1,000 (1.0 x 109/L) * Platelets \> or = 50,000 (50 x 109/L) * Total Bilirubin \< or = 1.5 x institutional limits unless documented Gilbert's syndrome (then \< 2.5 x institutional upper limit) * AST (SGOT)/ALT (SGPT) \< or = 2.0 x institutional upper limit of normal (unless known hepatic involvement then \< 3.5 x institutional upper limit) * Creatinine within normal institutional limits OR creatinine clearance \> or = 50mL/min for patients with creatinine levels above institutional normal * If female of childbearing age, negative serum pregnancy test within 7 days prior to the first dose of brentuximab vedotin in this study * Must be willing to use contraception during the study, and for 30 days following the last dose of study drug. * Able to understand and to sign a written consent document Exclusion Criteria: * Prior treatment with brentuximab vedotin and bendamustine in combination. May have received prior therapy with brentuximab vedotin or bendamustine separately. * Received either brentuximab vedotin or bendamustine within 3 months of receiving their first dose of protocol based therapy. * If brentuximab vedotin or bendamustine was previously received, had disease progression during the first 3 cycles of either brentuximab vedotin or bendamustine. * Systemic steroids that have not been stabilized to the equivalent of \< 10 mg/day of prednisone 7 days prior to the initiation of the trial. * ANY concurrent investigational agents. * Exposure to chemotherapy, radiotherapy, biologics or investigational agents within 3 weeks prior enrollment in the study. * Known cerebral or meningeal disease. * Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy the patients must be disease free and off treatment for \> or = 3 years. * Uncontrolled intercurrent illness including but not limited to: ongoing or active infection, systemic congestive heart failure Class III or IV by NYHA criteria, unstable angina pectoris, or cardiac arrhythmia, or in patients status post allogeneic transplantation with uncontrolled graft versus host disease (GVHD). * Pre-existing neuropathy grade III or greater. * Pregnant or nursing. * Known hypersensitivity to brentuximab vedotin, bendamustine, or mannitol. * Known Human Immunodeficiency Virus (HIV) positive, or hepatitis A, hepatitis B or hepatitis C; if hepatitis Bsurface antigen positive or Bcore antibody positive must have normal liver function tests and be willing and able to take anti-hepatitis medication such as lamivudine or equivalent.
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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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British Columbia Cancer Agency
Vancouver, British Columbia, V5z 4E6, Canada
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Center for Lymphoid Malignancies at CUMC
New York, New York, 10010, United States
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Princess Margaret Hospital
Toronto, Ontario, Canada
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