Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large C… (NCT01657331) | Clinical Trial Compass
CompletedPhase 1/2
Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL)
United States, Canada65 participantsStarted 2012-07
Plain-language summary
This is a phase 1/2 multicenter study to assess the safety and effectiveness of brentuximab vedotin and bendamustine, when given together, in patients with Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma (ALCL) that has either returned or did not respond to initial treatment(s). Patients will be accrued at Columbia University Medical Center (CUMC) and at two subsites in Canada.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 li…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination of Brentuximab Vedotin and Bendamustine (Phase 1)
Timeframe: 21 days
2
Maximum Tolerated Dose (MTD) of Bendamustine in Combination of Brentuximab Vedotin and Bendamustine (Phase 1)
Timeframe: 21 days
3
Number of Participants With Dose Limiting Toxicities (DLT) of Brentuximab Vedotin and Bendamustine in Phase 1
Timeframe: 21 days
4
Overall Response Rate for the Combination of Brentuximab Vedotin and Bendamustine