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Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma
NCT01508312 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is determine if 2 cycles of SGN-35 can be used instead of ICE prior to autologous stem cell transplant (ASCT) for relapsed and refractory HL. There are 2 steps to treating patients with relapsed or refractory HL. The first step is to shrink the lymphoma with chemotherapy. The chemotherapy regimen commonly used is called ICE. ICE is a combination of chemotherapy drugs: ifosfamide, carboplatin, and etoposide. The second step of treatment is to give high doses of chemotherapy and radiation therapy followed by infusion of stem cells. This is called an ASCT. This study will focus on the first step of treatment for relapsed and refractory HL. ICE chemotherapy can cause many side effects. We believe that there are patients who can receive less toxic treatments and still do well. We have learned from past studies that \[18F\]FDG-PET scans (which we will call "PET scans") can be used to predict who will do well after ASCT. PET scans are tests used to measure the metabolic activity of the disease. Patients without abnormal activity on their PET scan (negative PET scan) before ASCT are much more likely to be cured than those with activity on their PET scan (positive PET scan). In this study, instead of beginning with ICE chemotherapy, the patient will receive a new drug called Brentuximab vedotin (SGN-35). SGN-35 is a type of drug called an antibody drug conjugate. SGN-35 has 2 parts; a part that targets cancer cells (the antibody) and a cell killing part (the chemotherapy). The antibody part of SGN-35 sticks to a target called CD30. CD30 is an important molecule on some cancer cells (including Hodgkin lymphoma) and some normal cells of the immune system. The cell killing part of SGN-35 is a chemotherapy called monomethyl auristatin E (MMAE). It can kill cells that the antibody part of SGN-35 sticks to. Compared to ICE chemotherapy, SGN-has fewer side effects and does not require inpatient admission for treatment. We aim to determine whether patie
Conditions Studied
Interventions
- DRUG brentuximab vedotin (SGN-35)
- DRUG Brentuximab Vedotin (SGN-35)
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2012-01-05 |
| Est. Completion | 2024-03-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01508312
The ClinicalTrials.gov registry entry for NCT01508312 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 2,280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hodgkin's Lymphoma appearing as the primary indexed condition, and to 2 interventions — of which brentuximab vedotin (SGN-35) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01508312 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01508312 about?
NCT01508312 is a clinical study titled "Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma". The purpose of this study is determine if 2 cycles of SGN-35 can be used instead of ICE prior to autologous stem cell transplant (ASCT) for relapsed and refractory HL. There are 2 steps to treating patients with relapsed or refractory HL. The first step is to shrink the lymphoma with chemotherapy. T...
What is the current status of trial NCT01508312?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2012-01-05. Estimated completion is 2024-03-14.
What conditions does trial NCT01508312 study?
This clinical trial studies the following conditions: Hodgkin's Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01508312?
The interventions under investigation include: brentuximab vedotin (SGN-35) (DRUG), Brentuximab Vedotin (SGN-35) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01508312?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 2,280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01508312 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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