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Adult Lymphocyte Depletion Hodgkin LymphomaPhase 2NCT01476410

Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma

A Phase 2 study testing brentuximab vedotin, doxorubicin hydrochloride and vinblastine in people with Adult Lymphocyte Depletion Hodgkin Lymphoma and Adult Lymphocyte Predominant Hodgkin Lymphoma, run by Northwestern University at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies how well giving brentuximab vedotin together with combination chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin lymphoma (HL). Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
brentuximab vedotin, doxorubicin hydrochloride and vinblastine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
7 sitesUnited States
Study dates
Nov 2011to 26 May 2020
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
  • Previously untreated classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte depleted, lymphocyte-rich, and not otherwise specified [NOS]); nodular lymphocyte predominant Hodgkin lymphoma is not eligible
  • Stage II, III, and IV disease by Ann Arbor classification
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Patients must have bi-dimensional measurable disease documented in the lymphoma baseline tumor assessment form within 30 days prior to registration (at least 1.5 cm); patients with non-measurable disease in addition to measurable disease must have been assessed within 60 days prior to registration
  • Patients must have a bone marrow biopsy (bilateral preferred, unilateral acceptable) within 60 days prior to registration
Show all 15Show fewer
  • Patients must have a multi gated acquisition scan (MUGA) or echocardiogram within 60 days prior to study registration and the ejection fraction must be >= 45%
  • Absolute neutrophil count (ANC) > 1000/mm^3
  • Platelet count > 75,000/mm^3
  • Creatinine < 2.5 mg/dl
  • Bilirubin < 3.0 mg/dl
  • Patients with documented marrow involvement by lymphoma at the time of registration are not required to meet the above hematologic parameters
  • Patients must not have received prior chemotherapy or radiation therapy for the treatment of Hodgkin lymphoma
  • Both females and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
  • Patients must sign the informed consent form before registration

Who cannot join

  • Previous treatment with brentuximab vedotin or any other prior anti-CD30-based antibody therapy
  • History of another primary malignancy that has not been in remission for at least 3 years; (the following are exempt from the 3-year limit: early stage [stage I or II] breast cancer treated with surgery and radiation +/- hormones [without adjuvant chemotherapy], non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou test [PAP smear])
  • Known cerebral/meningeal disease
  • Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 1 week prior to first dose
  • Patients with hepatitis B surface antigen (HBsAg) positive hepatitis B virus (HBV) infection; patients with prior history of hepatitis B infection, but immune, with only Immunoglobulin G (IgG) hepatitis core antibody + (HBcAb +) must receive anti-viral prophylaxis (e.g., lamivudine 100mg orally [po] daily) for at least 1 week prior to cycle 1 and throughout induction and continuation therapy and for at least 6 months after the last brentuximab vedotin dose; in addition, consultation with a hepatologist is recommended
  • Patients with a known hypersensitivity to any excipient contained in the drug formulation
  • Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • NorthwesternU

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Memorial Sloan- Kettering Cancer Center

    New York, New York, 10065

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7835

  • Stanford University Medical Center

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase II Trial of Sequential SGN-35 Therapy With Adriamycin, Vinblastine, and Dacarbazine (S-AVD) for Older Patients With Untreated Hodgkin Lymphoma

This phase II trial studies how well giving brentuximab vedotin together with combination chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin lymphoma (HL). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, and dacarbazine (AVD), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving brentuximab vedotin, doxorubicin hydrochloride, vinblastine, and dacarbazine together may kill more cancer cells.

Read the detailed description

LEAD IN: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Being tested
brentuximab vedotin, doxorubicin hydrochloride, vinblastine, dacarbazine, quality-of-life assessment
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 vedotinDrug

    Also called anti-CD30 ADC SGN-35, anti-CD30 antibody-drug conjugate SGN-35, antibody-drug conjugate SGN-35, SGN-35

    Given IV

  • doxorubicin hydrochlorideDrug

    Also called ADM, ADR, Adria, Adriamycin PFS

    Given IV

  • vinblastineDrug

    Also called Velban, Velsar, VLB

    Given IV

  • dacarbazineDrug

    Also called DIC, DTIC, DTIC-Dome

    Given IV

  • quality-of-life assessmentProcedure or surgery

    Also called quality of life assessment

    Ancillary studies

  • DNA analysisGenetic

    Optional correlative studies

  • RNA analysisGenetic

    Optional correlative studies

  • fludeoxyglucose F 18Radiation

    Also called 18FDG, FDG

    Correlative studies

  • positron emission tomographyProcedure or surgery

    Also called FDG-PET, PET, PET scan, tomography, emission computed

    Correlative studies

  • laboratory biomarker analysisOther

    Optional correlative studies

  • immunohistochemistry staining methodOther

    Also called immunohistochemistry

    Optional correlative studies

  • polymorphism analysisGenetic

    Optional correlative studies

Study groups in NCT01476410
Study groupRoleWhat they receive
Treatment (antibody-drug conjugate and combination chemo)ExperimentalLEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: brentuximab vedotin; Drug: doxorubicin hydrochloride; Drug: vinblastine; Drug: dacarbazine; Procedure: quality-of-life assessment; Genetic: DNA analysis; Genetic: RNA analysis; Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: polymorphism analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Remission Rate After Chemotherapy

    The primary objective of this study is to evaluate the complete remission rate among older patients with HL receiving sequential brentuximab vedotin therapy with AVD chemotherapy

    Measured: after completion of AVD chemotherapy and prior to SGN-35 consolidation, approximately 9 months

Secondary outcomes (9)

  1. Overall Response Rate After 2 Cycles of SGN-35

    The incidence of overall response rate to induction SGN-35 will be reported for the initial 22 patients where PET is being employed.

    Measured: 2 cycles of SGN-35 lead-in therapy, approximately 42 days

  2. Complete Remission Rate Following 2 Cycles of SGN-35

    The incidence of CR rate to induction SGN-35 will be reported for the initial 22 patients where PET is being employed

    Measured: 2 cycles of lead-in SGN-35, approximately 42 days

  3. Safety of Sequential SGN-35/AVD/SGN-35 Therapy

    Detailed examination of Averse Events, laboratory test results, vital signs or other physical findings. Below we have summarized the top 10 most common Grade 3 and Grade 4 related adverse events. Please see the Adverse Events section of this record for a full listing of Adverse Events.

    Measured: From time of treatment to 30 days after discontinuation of study treatment

  4. 2-year Progression Free Survival

    Progression Free Survival (PFS) is defined as lymphoma progression or death from any cause. This outcome measure is the percentage of patients that have not progressed at 2 years from time of registration.

    Measured: 2 years from time of registration to study

  5. Overall Survival Following SGN-35/AVD Sequential Therapy

    Defined as the percentage of patients that are alive 2 years after registration.

    Measured: up to 2 years from the time of registration

  6. 2 Year Event-Free Survival

    An event is defined as treatment failure including discontinuation of treatment for any reason, such as disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death. This outcome measure is reported as the percentage of patient that did not have an event at 2 years from registration.

    Measured: From registration until treatment failure, up to 2 years

  7. Freedom From Progression

    Measured from the time of study entry to progression of disease. Other causes of treatment failure are not include in freedom from progression.

    Measured: from baseline to end of study, approximately 4 years

  8. Patient Reported Outcomes for Symptoms and Quality of Life

    Evaluate patient reported outcomes at baseline and during treatment to determine potential symptom palliation, treatment-related symptoms, and overall health-related quality of life. The Function Assessment of Cancer Therapy for Lymphoma (FACT-Lym) scale has a range of 0(minimum score) to 168 (maximum score). Higher scores indicate a better outcome.

    The mean scores for each timepoint are reported below.

    Measured: Baseline and AVD Cycle 1, a total of 6 weeks

  9. Association Between Cumulative Illness Rating Scale (CIRS) With Outcomes

    Number of co-morbidities collected for each patient at baseline and at the end of completion of all therapy utilizing the Cumulative Illness Rating Scare (CIRS). For binary outcomes such as CR, logistic regression will be used to assess the relationship with CIRS score; for time-to-event outcomes, the method of Kalan Meier and the log rank test will be used. The minimum score of the CIRS is 0 and the maximum score is 56. High Scores on the CIRS scale indicate that the patient has more severe comorbidities

    Measured: approximately 2 years from treatment start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completion6 Apr 2017
  4. Study completion26 May 2020

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01476410
Sponsor's protocol ID
NU 11H01
Other IDs
NCI-2011-00684, STU00046908
Status last verified
May 2026
First submitted
18 Oct 2011
Last updated
22 May 2026
Data monitoring committee
Yes

Publications

  • Evens AM, Advani RH, Helenowski IB, Fanale M, Smith SM, Jovanovic BD, Bociek GR, Klein AK, Winter JN, Gordon LI, Hamlin PA. Multicenter Phase II Study of Sequential Brentuximab Vedotin and Doxorubicin, Vinblastine, and Dacarbazine Chemotherapy for Older Patients With Untreated Classical Hodgkin Lymphoma. J Clin Oncol. 2018 Oct 20;36(30):3015-3022. doi: 10.1200/JCO.2018.79.0139. Epub 2018 Sep 4.

    PubMed 30179569

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing brentuximab vedotin, doxorubicin hydrochloride and vinblastine in people with Adult Lymphocyte Depletion Hodgkin Lymphoma and Adult Lymphocyte Predominant Hodgkin Lymphoma, run by Northwestern University at 7 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 15 inclusion and 7 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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.

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 22 May 2026). 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?

Complete Remission Rate After Chemotherapy (time frame: after completion of AVD chemotherapy and prior to SGN-35 consolidation, approximately 9 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 NCT01476410, which also lists 1 linked publication.

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 22 May 2026.

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