Hodgkin's LymphomaPhase 2NCT01508312
Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma
A Phase 2 study testing brentuximab vedotin (SGN-35) in people with Hodgkin's Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 72 years
- Conditions the study is for
- Hodgkin's Lymphoma
- What is being tested?
- brentuximab vedotin (SGN-35)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2012to 14 Mar 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 72 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologic diagnosis of cd30 positive classical Hodgkin's lymphoma.
- Primary refractory or relapsed disease proven by biopsy or fine needle aspiration (cytology) of an involved site. Pathology must be reviewed at MSKCC.
- Relapse or refractory disease following doxorubicin or nitrogen mustard containing front-line therapy
- Fluorodeoxyglucose (FDG)-avid disease by FDG-PET/CT and measurable disease of at least 1.5 cm by spiral CT, as assessed by the site radiologist.
- Cardiac ejection fraction of greater than 45%, measured since last chemotherapy.
- Hemoglobin-adjusted diffusing capacity for carbon monoxide of greater than 50% on pulmonary function testing, measured since last chemotherapy
Show all 12Show fewer
- Serum creatinine < or = to 1.5 mg/dl; if creatinine >1.5 mg/dl then the measured 12- or 24-hour creatinine clearance must be >60 ml/minute.
- ANC>1000/μl and Platelets>50,000/μl
- Total bilirubin < 2.0 mg/dl in the absence of a history of Gilbert's disease.
- Females of childbearing age must be on an acceptable form of birth control.
- Age between 12 and 72
- HIV I and II negative.
Who cannot join
- Received more than 1 prior treatment (combined modality therapy represents 1 treatment) for Hodgkin Lymphoma
- Hepatitis B surface antigen positive or hepatitis B core antibody positive.
- Known pregnancy or breast-feeding.
- Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, makes participation in this study inappropriate.
- Peripheral neuropathy > grade 2
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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).
Read more
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 patients can avoid treatment with ICE prior to ASCT. We will use the results of the PET scan to determine whether the patient needs additional chemotherapy before ASCT. If the PET scan is negative, the patient will be referred to ASCT and not receive ICE chemotherapy. If the PET scan is positive, the physician will discuss further treatment options with the patient.
- Conditions
- Hodgkin's Lymphoma
- Being tested
- brentuximab vedotin (SGN-35)
- Keywords
- CARBOPLATIN, ETOPOSIDE (VP-16), IFOSFAMIDE, SGN-35 (BRENTUXIMAB VEDOTIN), 11-142
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brentuximab vedotin (SGN-35)Drug
Patients will receive 2 cycles of weekly brentuximab vedotin, 1.2mg/kg on days 1, 8, and 15 of each 28 day cycle. Patients with pre-treatment positive bone marrow biopsies will have repeat bone marrow biopsies if the PET scan is negative. FDG-PET/CT will be repeated after 2 cycles of treatment within 1 week of the last dose of cycle 2. Patients with persistent abnormalities on FDG-PET/CT following 2 cycles of brentuximab vedotin will receive 2 cycles of augmented ICE. The first cycle of augmented ICE will be initiated 7-14 days after the last dose of SGN-35. FDG-PET/CT will be repeated within 7-14 days following the second cycle of augmented ICE. Stem cell mobilization can be performed following the first or second cycle of augmented ICE.
Brentuximab Vedotin (SGN-35)Drug
Patients will receive 2 cycles of weekly brentuximab vedotin, 1.2mg/kg on days 1, 8, and 15 of each 28 day cycle. FDG-PET/CT will be repeated after 2 cycles of treatment within 1 week of the last dose of cycle 2. Patients with pre-treatment positive bone marrow biopsies will have repeat bone marrow biopsies if the PET scan is negative. Patients with normalization of FDG-PET/CT and negative bone marrow biopsies following 2 cycles of brentuximab vedotin will undergo stem cell mobilization in preparation for ASCT.
| Study group | Role | What they receive |
|---|---|---|
| FDG-PET abnormal | Experimental | Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations. Receives: Drug: brentuximab vedotin (SGN-35) |
| FDG-PET normalization | Experimental | Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations. Receives: Drug: Brentuximab Vedotin (SGN-35) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDG-PET/CT Standardized Uptake Value at 12 Months
Following salvage therapy with brentuximab vedotin (SGN-35) alone or followed by augmented ICE chemotherapy.
Measured: 12 months
Secondary outcomes (2)
Overall Response Rate
Overall Response Rate (CR and PR rate) to brentuximab vedotin alone
Measured: 2 years
Participants Evaluated for Toxicity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study start5 Jan 2012
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc., Hôpitaux Universitaires Henri Mondor, France
- Responsible party
- Sponsor
- Investigators
- Allison Moskowitz, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508312
- Sponsor's protocol ID
- 11-142
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2012
- Last updated
- 21 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Driessen J, Zwezerijnen GJC, Schoder H, Kersten MJ, Moskowitz AJ, Moskowitz CH, Eertink JJ, Heymans MW, Boellaard R, Zijlstra JM. Prognostic model using 18F-FDG PET radiomics predicts progression-free survival in relapsed/refractory Hodgkin lymphoma. Blood Adv. 2023 Nov 14;7(21):6732-6743. doi: 10.1182/bloodadvances.2023010404.
PubMed 37722357Moskowitz AJ, Schoder H, Yahalom J, McCall SJ, Fox SY, Gerecitano J, Grewal R, Hamlin PA, Horwitz S, Kobos R, Kumar A, Matasar M, Noy A, Palomba ML, Perales MA, Portlock CS, Sauter C, Shukla N, Steinherz P, Straus D, Trippett T, Younes A, Zelenetz A, Moskowitz CH. PET-adapted sequential salvage therapy with brentuximab vedotin followed by augmented ifosamide, carboplatin, and etoposide for patients with relapsed and refractory Hodgkin's lymphoma: a non-randomised, open-label, single-centre, phase 2 study. Lancet Oncol. 2015 Mar;16(3):284-92. doi: 10.1016/S1470-2045(15)70013-6. Epub 2015 Feb 13.
PubMed 25683846
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brentuximab Vedotin (SGN-35) in Transplant Eligible Patients With Relapsed or Refractory Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT01508312
- Acronym / sponsor ID
- 11-142
- Conditions
- Hodgkin's Lymphoma
- Keywords
- CARBOPLATIN, ETOPOSIDE (VP-16), IFOSFAMIDE, SGN-35 (BRENTUXIMAB VEDOTIN), 11-142
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Seagen Inc., Hôpitaux Universitaires Henri Mondor, France
- Study start
- 5 Jan 2012 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Posted 21 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patients can avoid treatment with ICE prior to ASCT. We will use the results of the PET scan to determine whether the patient needs additional chemotherapy before ASCT. If the PET scan is negative, the patient will be referred to ASCT and not receive ICE chemotherapy. If the PET scan is positive, the physician will discuss further treatment options with the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDG-PET abnormal | Experimental | Drug: brentuximab vedotin (SGN-35)Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations. |
| FDG-PET normalization | Experimental | Drug: Brentuximab Vedotin (SGN-35)Patients will receive 2 cycles of weekly brentuximab vedotin and then undergo evaluation with FDGPET/CT. Patients with normalization of FDG-PET/CT will proceed to ASCT. Patients with persistent abnormalities on FDG-PET/CT will receive 2 cycles of augmented ICE chemotherapy followed by repeat FDG-PET/CT prior to ASCT. Following augmented ICE, patients with negative FDG-PET/CT will proceed to ASCT. Those with persistent abnormalities on FDG-PET/CT will be treated according to their physician's recommendations. |
Who may qualify
- Ages
- 12 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Histologic diagnosis of cd30 positive classical Hodgkin's lymphoma.
- Primary refractory or relapsed disease proven by biopsy or fine needle aspiration (cytology) of an involved site. Pathology must be reviewed at MSKCC.
- Relapse or refractory disease following doxorubicin or nitrogen mustard containing front-line therapy
- Fluorodeoxyglucose (FDG)-avid disease by FDG-PET/CT and measurable disease of at least 1.5 cm by spiral CT, as assessed by the site radiologist.
- Cardiac ejection fraction of greater than 45%, measured since last chemotherapy.
Key exclusion criteria (5 listed)
- Received more than 1 prior treatment (combined modality therapy represents 1 treatment) for Hodgkin Lymphoma
- Hepatitis B surface antigen positive or hepatitis B core antibody positive.
- Known pregnancy or breast-feeding.
- Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, makes participation in this study inappropriate.
- Peripheral neuropathy > grade 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brentuximab vedotin (SGN-35)Patients will receive 2 cycles of weekly brentuximab vedotin, 1.2mg/kg on days 1, 8, and 15 of each 28 day cycle. Patients with pre-treatment positive bone marrow biopsies will have repeat bone marrow biopsies if the PET scan is negative. FDG-PET/CT will be repeated after 2 cycles of treatment within 1 week of the last dose of cycle 2. Patients with persistent abnormalities on FDG-PET/CT following 2 cycles of brentuximab vedotin will receive 2 cycles of augmented ICE. The first cycle of augmented ICE will be initiated 7-14 days after the last dose of SGN-35. FDG-PET/CT will be repeated within 7-14 days following the second cycle of augmented ICE. Stem cell mobilization can be performed following the first or second cycle of augmented ICE. | Drug | FDG-PET abnormal |
| Brentuximab Vedotin (SGN-35)Patients will receive 2 cycles of weekly brentuximab vedotin, 1.2mg/kg on days 1, 8, and 15 of each 28 day cycle. FDG-PET/CT will be repeated after 2 cycles of treatment within 1 week of the last dose of cycle 2. Patients with pre-treatment positive bone marrow biopsies will have repeat bone marrow biopsies if the PET scan is negative. Patients with normalization of FDG-PET/CT and negative bone marrow biopsies following 2 cycles of brentuximab vedotin will undergo stem cell mobilization in preparation for ASCT. | Drug | FDG-PET normalization |
Primary outcome
FDG-PET/CT Standardized Uptake Value at 12 Months
Time frame: 12 months
Following salvage therapy with brentuximab vedotin (SGN-35) alone or followed by augmented ICE chemotherapy.
2 secondary outcomes
Overall Response Rate
Time frame: 2 years
Participants Evaluated for Toxicity
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37722357Driessen J, Zwezerijnen GJC, Schoder H, Kersten MJ, Moskowitz AJ, Moskowitz CH, Eertink JJ, Heymans MW, Boellaard R, Zijlstra JM. Prognostic model using 18F-FDG PET radiomics predicts progression-free survival in relapsed/refractory Hodgkin lymphoma. Blood Adv. 2023 Nov 14;7(21):6732-6743. doi: 10.1182/bloodadvances.2023010404.
- Derived from this study: PubMed 25683846Moskowitz AJ, Schoder H, Yahalom J, McCall SJ, Fox SY, Gerecitano J, Grewal R, Hamlin PA, Horwitz S, Kobos R, Kumar A, Matasar M, Noy A, Palomba ML, Perales MA, Portlock CS, Sauter C, Shukla N, Steinherz P, Straus D, Trippett T, Younes A, Zelenetz A, Moskowitz CH. PET-adapted sequential salvage therapy with brentuximab vedotin followed by augmented ifosamide, carboplatin, and etoposide for patients with relapsed and refractory Hodgkin's lymphoma: a non-randomised, open-label, single-centre, phase 2 study. Lancet Oncol. 2015 Mar;16(3):284-92. doi: 10.1016/S1470-2045(15)70013-6. Epub 2015 Feb 13.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Moskowitz, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing brentuximab vedotin (SGN-35) in people with Hodgkin's Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDG-PET/CT Standardized Uptake Value at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01508312, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.