Hodgkin LymphomaNCT01868451
Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
A study testing Brentuximab vedotin (SGN-35), Doxorubicin HCL and Vinblastine Sulfate in people with Hodgkin Lymphoma, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.
Trial summary
The purpose of this study is to compare the outcomes across the 4 different treatment groups. The investigators hope that this treatment will improve the ability to cure more patients with HL and also limit the long-term side effects from the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Brentuximab vedotin (SGN-35), Doxorubicin HCL and Vinblastine Sulfate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 10 sitesUnited States
- Study dates
- May 2013to 2 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of classical, CD30 positive Hodgkin lymphoma confirmed at enrolling institution
- FDG-avid disease by FDG-PET/CT and measurable disease of at least 1.5 cm by CT
- Ann Arbor Stage I or II disease
- Disease bulk defined as any lymph node mass with transverse maximal diameter > 7.0 cm OR coronal maximal diameter > 7.0 cm on CT imaging
- Females of childbearing age must be on an acceptable form of birth control per institutional standards
- Ages 18 and over
Who cannot join
- Cardiac ejection fraction ≤ 50%
- Hemoglobin-adjusted diffusing capacity for carbon monoxide < 40%
- ANC≤1000/μl and Platelets≤75,000/μl
- Total bilirubin ≥ 2.0 mg/dl in the absence of a history of Gilbert's disease
- Serum creatinine clearance of <30 mL/min as estimated by the Cockcroft-Gault Method
- Known pregnancy or breast-feeding
Show all 10Show fewer
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Medical illness unrelated to Hodgkin Lymphoma, which, in the opinion of the attending physician and/or MSKCC principal investigator, makes participation in this study inappropriate.
- Peripheral neuropathy > grade 1
- Patients receiving chronic treatment with systemic steroids. However, patients can receive up to 10 days of steroid therapy prior to starting treatment with BV+AVD.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
City of Hope
Duarte, California, 91010
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Rochester Medical Center
Rochester, New York
Stanford University Medical Center
Stanford, California, 94305-5408
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
The purpose of this study is to compare the outcomes across the 4 different treatment groups. The investigators hope that this treatment will improve the ability to cure more patients with HL and also limit the long-term side effects from the treatment. Although eliminating radiation in cohort 4 will eliminate the risk for long-term side effects from radiation, it is also possible that with BV+AVD chemotherapy alone there may be an increased risk of the Hodgkin lymphoma coming back after initial treatment.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Brentuximab vedotin (SGN-35), Doxorubicin HCL, Vinblastine Sulfate, Dacarbazine, Involved-Site Radiation Therapy (ISRT)
- Keywords
- DACARBAZINE, DOXORUBICIN/ADRIAMYCIN, SGN-35 (BRENTUXIMAB VEDOTIN), VINBLASTINE, Involved-site radiation therapy (ISRT), Early stage, 13-034
- 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
Doxorubicin HCLDrug
Vinblastine SulfateDrug
DacarbazineDrug
Involved-Site Radiation Therapy (ISRT)Radiation
Interim PETProcedure or surgery
consolidation volume RT (CVRT)Radiation
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (completed accrual) | Experimental | Patients received 4 cycles of brentuximab vedotin \& AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, \& Dacarbazine 375 mg/m2 will be administered on days 1 and 15 of each 28 day cycle. This may be followed by 30 Gy involved site radiotherapy. Involved site radiotherapy should be initiated from 12 days to 42 days after completion of chemotherapy. It is mandatory to administer prophylactic growth factor support starting with cycle 1. Choice of growth factor and dosing can be determined at the discretion of the treating physican. Receives: Drug: Brentuximab vedotin (SGN-35); Drug: Doxorubicin HCL; Drug: Vinblastine Sulfate; Drug: Dacarbazine; Radiation: Involved-Site Radiation Therapy (ISRT); Procedure: Interim PET |
| Cohort 2 | Experimental | Patients with early stage, unfavorable risk Hodgkin lymphoma. The definition of disease bulk, one of the unfavorable risk features, has been updated, and is defined as the presence of any lymph node mass with transverse maximal diameter > 7.0 cm OR coronal maximal diameter > 7.0 cm. Patients will receive 4 cycles of brentuximab vedotin \& AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, and Dacarbazine 375 mg/m2 will be administered on days 1 \& 15 of each 28 day cycle. This may be followed by 20 Gy involved site radiotherapy. Receives: Drug: Brentuximab vedotin (SGN-35); Drug: Doxorubicin HCL; Drug: Vinblastine Sulfate; Drug: Dacarbazine; Radiation: Involved-Site Radiation Therapy (ISRT); Procedure: Interim PET |
| Cohort 3 | Experimental | Patients will have early stage, unfavorable risk classical Hodgkin lymphoma with disease bulk defined as the presence of any lymph node mass with transverse maximal diameter > 7.0 cm or coronal maximal diameter > 7.0 cm. Patients will receive 4 cycles of brentuximab vedotin and AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, and Dacarbazine 375 mg/m2 will be administered on days 1 and 15 of each 28 day cycle. This may be followed by 30.6 Gy CVRT. Receives: Drug: Brentuximab vedotin (SGN-35); Drug: Doxorubicin HCL; Drug: Vinblastine Sulfate; Drug: Dacarbazine; Procedure: Interim PET; Radiation: consolidation volume RT (CVRT) |
| Cohort 4 | Experimental | Patients will have early stage, unfavorable risk classical Hodgkin lymphoma with disease bulk defined as the presence of any lymph node mass with transverse maximal diameter > 7.0 cm or coronal maximal diameter > 7.0 cm. In this cohort. Pts will receive 4 cycles of brentuximab vedotin \& AVD chemo. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 \& 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, \& Dacarbazine 375 mg/m2 will be administered on days 1 \& 15 of each 28 day cycle. Pts whose PET scan is negative after 4 cycles of brentuximab vedotin \& AVD chemotherapy will not receive RT. Pts whose PET scan is positive after 4 cycles of brentuximab vedotin \& AVD chemo, but subsequent biopsy is neg, will also receive no RT. Upon MSK PI approval, if the simulation can't be covered by the institution or the pts insurance, a diagnostic IV contrast CT neck \& diagnostic IV contrast CT CAP scan will be done in addition to the FDG-PET done after 4 cycles of chemo. Receives: Drug: Brentuximab vedotin (SGN-35); Drug: Doxorubicin HCL; Drug: Vinblastine Sulfate; Drug: Dacarbazine; Procedure: Interim PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of significant pulmonary toxicity
specifically non-infectious pneumonitis The definition of unacceptable pulmonary toxicity will be defined as the development of grade 2 or higher pneumonitis as defined by Common Terminology Criteria for Adverse Events (CTCAE version 4).
Measured: 1 year
complete responses (all cohorts)
Evaluate the rate of PET-negative complete responses after completion of the treatment program (8 weeks (+/- 2 weeks) after completion of radiotherapy).
Measured: 1 year
Secondary outcomes (1)
Evaluate the prognostic significance
(i.e. correlation with progression free survival) of interim fluorodeoxyglucose-positron emission tomography (PET) in this patient population measured by visual analysis and semi-quantitative analysis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startMay 2013
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hodgkin 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc., University of Rochester, City of Hope Medical Center, Stanford University
- Responsible party
- Sponsor
- Investigators
- Anita Kumar, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868451
- Sponsor's protocol ID
- 13-034
- Status last verified
- Jun 2026
- First submitted
- 30 May 2013
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goldkuhle M, Kreuzberger N, von Tresckow B, Eichenauer DA, Specht L, Monsef I, Skoetz N. Chemotherapy alone versus chemotherapy plus radiotherapy for adults with early-stage Hodgkin's lymphoma. Cochrane Database Syst Rev. 2024 Dec 2;12(12):CD007110. doi: 10.1002/14651858.CD007110.pub4.
PubMed 39620432Kumar A, Casulo C, Advani RH, Budde E, Barr PM, Batlevi CL, Caron P, Constine LS, Dandapani SV, Drill E, Drullinsky P, Friedberg JW, Grieve C, Hamilton A, Hamlin PA, Hoppe RT, Horwitz SM, Joseph A, Khan N, Laraque L, Matasar MJ, Moskowitz AJ, Noy A, Palomba ML, Schoder H, Straus DJ, Vemuri S, Yang J, Younes A, Zelenetz AD, Yahalom J, Moskowitz CH. Brentuximab Vedotin Combined With Chemotherapy in Patients With Newly Diagnosed Early-Stage, Unfavorable-Risk Hodgkin Lymphoma. J Clin Oncol. 2021 Jul 10;39(20):2257-2265. doi: 10.1200/JCO.21.00108. Epub 2021 Apr 28.
PubMed 33909449Kumar A, Casulo C, Yahalom J, Schoder H, Barr PM, Caron P, Chiu A, Constine LS, Drullinsky P, Friedberg JW, Gerecitano JF, Hamilton A, Hamlin PA, Horwitz SM, Jacob AG, Matasar MJ, McArthur GN, McCall SJ, Moskowitz AJ, Noy A, Palomba ML, Portlock CS, Straus DJ, VanderEls N, Verwys SL, Yang J, Younes A, Zelenetz AD, Zhang Z, Moskowitz CH. Brentuximab vedotin and AVD followed by involved-site radiotherapy in early stage, unfavorable risk Hodgkin lymphoma. Blood. 2016 Sep 15;128(11):1458-64. doi: 10.1182/blood-2016-03-703470. Epub 2016 Jul 25.
PubMed 27458003
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT01868451
- Acronym / sponsor ID
- 13-034
- Conditions
- Hodgkin Lymphoma
- Keywords
- DACARBAZINE, DOXORUBICIN/ADRIAMYCIN, SGN-35 (BRENTUXIMAB VEDOTIN), VINBLASTINE, Involved-site radiation therapy (ISRT), Early stage, 13-034
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Seagen Inc., University of Rochester, City of Hope Medical Center, Stanford University
- Study start
- May 2013 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
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 to compare the outcomes across the 4 different treatment groups. The investigators hope that this treatment will improve the ability to cure more patients with HL and also limit the long-term side effects from the treatment. Although eliminating radiation in cohort 4 will eliminate the risk for long-term side effects from radiation, it is also possible that with BV+AVD chemotherapy alone there may be an increased risk of the Hodgkin lymphoma coming back after initial treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (completed accrual) | Experimental | Drug: Brentuximab vedotin (SGN-35), Drug: Doxorubicin HCL, Drug: Vinblastine Sulfate, Drug: Dacarbazine, Radiation: Involved-Site Radiation Therapy (ISRT), Procedure: Interim PETPatients received 4 cycles of brentuximab vedotin \& AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, \& Dacarbazine 375 mg/m2 will be administered on days 1 and 15 of each 28 day cycle. This may be followed by 30 Gy involved site radiotherapy. Involved site radiotherapy should be initiated from 12 days to 42 days after completion of chemotherapy. It is mandatory to administer prophylactic growth factor support starting with cycle 1. Choice of growth factor and dosing can be determined at the discretion of the treating physican. |
| Cohort 2 | Experimental | Drug: Brentuximab vedotin (SGN-35), Drug: Doxorubicin HCL, Drug: Vinblastine Sulfate, Drug: Dacarbazine, Radiation: Involved-Site Radiation Therapy (ISRT), Procedure: Interim PETPatients with early stage, unfavorable risk Hodgkin lymphoma. The definition of disease bulk, one of the unfavorable risk features, has been updated, and is defined as the presence of any lymph node mass with transverse maximal diameter > 7.0 cm OR coronal maximal diameter > 7.0 cm. Patients will receive 4 cycles of brentuximab vedotin \& AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, and Dacarbazine 375 mg/m2 will be administered on days 1 \& 15 of each 28 day cycle. This may be followed by 20 Gy involved site radiotherapy. |
| Cohort 3 | Experimental | Drug: Brentuximab vedotin (SGN-35), Drug: Doxorubicin HCL, Drug: Vinblastine Sulfate, Drug: Dacarbazine, Procedure: Interim PET, Radiation: consolidation volume RT (CVRT)Patients will have early stage, unfavorable risk classical Hodgkin lymphoma with disease bulk defined as the presence of any lymph node mass with transverse maximal diameter > 7.0 cm or coronal maximal diameter > 7.0 cm. Patients will receive 4 cycles of brentuximab vedotin and AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, and Dacarbazine 375 mg/m2 will be administered on days 1 and 15 of each 28 day cycle. This may be followed by 30.6 Gy CVRT. |
| Cohort 4 | Experimental | Drug: Brentuximab vedotin (SGN-35), Drug: Doxorubicin HCL, Drug: Vinblastine Sulfate, Drug: Dacarbazine, Procedure: Interim PETPatients will have early stage, unfavorable risk classical Hodgkin lymphoma with disease bulk defined as the presence of any lymph node mass with transverse maximal diameter > 7.0 cm or coronal maximal diameter > 7.0 cm. In this cohort. Pts will receive 4 cycles of brentuximab vedotin \& AVD chemo. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 \& 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, \& Dacarbazine 375 mg/m2 will be administered on days 1 \& 15 of each 28 day cycle. Pts whose PET scan is negative after 4 cycles of brentuximab vedotin \& AVD chemotherapy will not receive RT. Pts whose PET scan is positive after 4 cycles of brentuximab vedotin \& AVD chemo, but subsequent biopsy is neg, will also receive no RT. Upon MSK PI approval, if the simulation can't be covered by the institution or the pts insurance, a diagnostic IV contrast CT neck \& diagnostic IV contrast CT CAP scan will be done in addition to the FDG-PET done after 4 cycles of chemo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologic diagnosis of classical, CD30 positive Hodgkin lymphoma confirmed at enrolling institution
- FDG-avid disease by FDG-PET/CT and measurable disease of at least 1.5 cm by CT
- Ann Arbor Stage I or II disease
- Disease bulk defined as any lymph node mass with transverse maximal diameter > 7.0 cm OR coronal maximal diameter > 7.0 cm on CT imaging
- Females of childbearing age must be on an acceptable form of birth control per institutional standards
Key exclusion criteria (10 listed)
- Cardiac ejection fraction ≤ 50%
- Hemoglobin-adjusted diffusing capacity for carbon monoxide < 40%
- ANC≤1000/μl and Platelets≤75,000/μl
- Total bilirubin ≥ 2.0 mg/dl in the absence of a history of Gilbert's disease
- Serum creatinine clearance of <30 mL/min as estimated by the Cockcroft-Gault Method
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) | Drug | Cohort 1 (completed accrual), Cohort 2, Cohort 3, Cohort 4 |
| Doxorubicin HCL | Drug | Cohort 1 (completed accrual), Cohort 2, Cohort 3, Cohort 4 |
| Vinblastine Sulfate | Drug | Cohort 1 (completed accrual), Cohort 2, Cohort 3, Cohort 4 |
| Dacarbazine | Drug | Cohort 1 (completed accrual), Cohort 2, Cohort 3, Cohort 4 |
| Involved-Site Radiation Therapy (ISRT) | Radiation | Cohort 1 (completed accrual), Cohort 2 |
| Interim PET | Procedure or surgery | Cohort 1 (completed accrual), Cohort 2, Cohort 3, Cohort 4 |
| consolidation volume RT (CVRT) | Radiation | Cohort 3 |
Primary outcome
development of significant pulmonary toxicity
Time frame: 1 year
specifically non-infectious pneumonitis The definition of unacceptable pulmonary toxicity will be defined as the development of grade 2 or higher pneumonitis as defined by Common Terminology Criteria for Adverse Events (CTCAE version 4).
complete responses (all cohorts)
Time frame: 1 year
Evaluate the rate of PET-negative complete responses after completion of the treatment program (8 weeks (+/- 2 weeks) after completion of radiotherapy).
1 secondary outcome
Evaluate the prognostic significance
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 39620432Goldkuhle M, Kreuzberger N, von Tresckow B, Eichenauer DA, Specht L, Monsef I, Skoetz N. Chemotherapy alone versus chemotherapy plus radiotherapy for adults with early-stage Hodgkin's lymphoma. Cochrane Database Syst Rev. 2024 Dec 2;12(12):CD007110. doi: 10.1002/14651858.CD007110.pub4.
- Derived from this study: PubMed 33909449Kumar A, Casulo C, Advani RH, Budde E, Barr PM, Batlevi CL, Caron P, Constine LS, Dandapani SV, Drill E, Drullinsky P, Friedberg JW, Grieve C, Hamilton A, Hamlin PA, Hoppe RT, Horwitz SM, Joseph A, Khan N, Laraque L, Matasar MJ, Moskowitz AJ, Noy A, Palomba ML, Schoder H, Straus DJ, Vemuri S, Yang J, Younes A, Zelenetz AD, Yahalom J, Moskowitz CH. Brentuximab Vedotin Combined With Chemotherapy in Patients With Newly Diagnosed Early-Stage, Unfavorable-Risk Hodgkin Lymphoma. J Clin Oncol. 2021 Jul 10;39(20):2257-2265. doi: 10.1200/JCO.21.00108. Epub 2021 Apr 28.
- Derived from this study: PubMed 27458003Kumar A, Casulo C, Yahalom J, Schoder H, Barr PM, Caron P, Chiu A, Constine LS, Drullinsky P, Friedberg JW, Gerecitano JF, Hamilton A, Hamlin PA, Horwitz SM, Jacob AG, Matasar MJ, McArthur GN, McCall SJ, Moskowitz AJ, Noy A, Palomba ML, Portlock CS, Straus DJ, VanderEls N, Verwys SL, Yang J, Younes A, Zelenetz AD, Zhang Z, Moskowitz CH. Brentuximab vedotin and AVD followed by involved-site radiotherapy in early stage, unfavorable risk Hodgkin lymphoma. Blood. 2016 Sep 15;128(11):1458-64. doi: 10.1182/blood-2016-03-703470. Epub 2016 Jul 25.
- 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.
Anita Kumar, MD principal investigator
Memorial Sloan Kettering Cancer Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brentuximab vedotin (SGN-35), Doxorubicin HCL and Vinblastine Sulfate in people with Hodgkin Lymphoma, run by Memorial Sloan Kettering Cancer Center at 10 sites 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 6 inclusion and 10 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
development of significant pulmonary toxicity (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT01868451, which also lists 3 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 4 Jun 2026.