Hodgkin LymphomaPhase 2NCT02505269
Brentuximab Vedotin Plus AD in Non-bulky Limited Stage Hodgkin Lymphoma
A Phase 2 study testing Brentuximab Vedotin, Adriamycin and Dacarbazine in people with Hodgkin Lymphoma, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
Limited stage Hodgkin lymphoma is a highly curable disease, but standard treatment with ABVD chemotherapy and radiation can lead to late risks of secondary cancers, lung injury, heart injury, and others. 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, Adriamycin and Dacarbazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2015to Jun 2019
- Phase
- Phase 2
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
- Previously untreated stage IA, IB, or IIA classical Hodgkin Lymphoma
- Non-bulky disease defined as less than 10 cm in maximal diameter
- Measurable disease ≥1.5 cm
- Age ≥18
- ECOG performance status 0-2 (see Appendix B)
- Participants must have initial organ and marrow function as defined below:
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- Absolute neutrophil count ≥ 1,000/mcL
- Platelets ≥100,000/mcL
- Total bilirubin ≤ 2, unless due to Gilbert's disease
- AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
- Creatinine clearance ≥ 30 mL/min
- LVEF by echocardiogram or MUGA within institutional normal limits
- Participant must be willing to use two effective forms of birth control during protocol therapy. Men and women must continue using two effective forms of birth control for 6 months following treatment.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Participants who have had prior cHL-directed chemotherapy or radiotherapy
- Participants may not be receiving any other investigational agents
- Participants with known CNS involvement of lymphoma
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Adriamycin, Dacarbazine, or brentuximab
- Pre-existing grade 2 or greater neuropathy
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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- Pregnant women are excluded from this study because brentuximab is an antibody drug conjugate with a linked potent anti-tubule agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with brentuximab, breastfeeding should be discontinued if the mother is treated with brentuximab. These potential risks may also apply to other agents used in this study.
- Participants with a history of a different malignancy are ineligible unless they have been disease free for 1 year and considered at low risk for relapse, except for: cervical cancer in situ, ductal carcinoma in situ, localized prostate cancer with no detectable disease by imaging studies, and non-melanoma cancers of the skin, which are eligible at any time.
- Known HIV positivity
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Limited stage Hodgkin lymphoma is a highly curable disease, but standard treatment with ABVD chemotherapy and radiation can lead to late risks of secondary cancers, lung injury, heart injury, and others. This trial eliminates radiation therapy and reduces intensity of chemotherapy by incorporating the highly active FDA-approved targeted therapy brentuximab vedotin, an antibody-drug conjugate specifically against the lymphoma cells, combined with the standard chemotherapy drugs Adriamycin and Dacarbazine (AD).
Read the detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved brentuximab vedotin (brentuximab) as part of the initial treatment of Hodgkin lymphoma. Currently, brentuximab is FDA-approved for treatment of relapsed Hodgkin lymphoma.
- Brentuximab works by binding specifically to Hodgkin lymphoma cells, entering the cells, and then releasing the drug to destroy the cell.
- The chemotherapy drugs Adriamycin and Dacarbazine (AD) which which participants will receive in this research study are approved for use in people with Hodgkin Lymphoma.
- Patients will not receive planned radiation therapy, or the drugs bleomycin or vinblastine.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Brentuximab Vedotin, Adriamycin, Dacarbazine
- Keywords
- limited stage, Hodgkin's disease, non-bulky
- 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 Adcetris
AdriamycinDrug
Also called Doxorubicin, Rubex ®
DacarbazineDrug
Also called DTIC-Dome®, DTIC, DIC, Imidazole Carboxamide
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab Vedotin | Experimental | The following procedures will take place during study visits beginning after the screening procedures:
- Participants will receive combination therapy:
* Brentuximab Vedotin intravenously on predetermined days per cycle
* Adriamycin intravenously on predetermined days per cycle
* Dacarbazine intravenously on predetermined days per cycle Receives: Drug: Brentuximab Vedotin; Drug: Adriamycin; Drug: Dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
The number of patients that achieved a complete response (CR) to therapy as assessed by the revised International Working Group Criteria.
Complete response:
- Lymph nodes and extralymphatic sites: Score 1, 2, or 3 with or without a residual mass on 5-point (Daeuville) scale
- Bone Marrow: No evidence of FDG-avi disease
- No new lesions
Deauville Criteria for PET scan Interpretation in Lymphoma
Five-point scale:
- No Uptake
- Uptake ≤ mediastinum
- Uptake >mediastinum but ≤ liver
- Uptake moderately increased compared to liver at any site
- Uptake markedly increased compared to the liver at any site or/and new sites of disease
Measured: 4-6 months
Secondary outcomes (2)
Overall Response Rate
The number of patients that achieved a complete Metabolic Response (CR) or Partial Metabolic Response (PR) to therapy as assessed by the revised International Working Group Criteria.
Complete Metabolic Response:
Lymph nodes and extralymphatic sites: Score 1, 2, or 3 with or without a residual mass on 5-point (Daeuville) scale Bone Marrow: No evidence of FDG-avi disease No new lesions
Partial Metabolic Response:
>Lymph nodes and extralymphatic sites: Score 4, 5 with reduced uptake compared with baseline and residual mass(es) of any size.
Deauville Criteria for PET scan Interpretation in Lymphoma
Five-point scale:
- No Uptake
- Uptake ≤ mediastinum
- Uptake >mediastinum but ≤ liver
- Uptake moderately increased compared to liver at any site
- Uptake markedly increased compared to the liver at any site or/and new sites of disease
Measured: 4-6 months
Number of Patients With Grade III and IV Adverse Events
The number of patients that experienced grade III and grade IV adverse events that were deemed to be possibly, probably, or definitely related to study treatment. Adverse events were assessed using Common Toxicology Criteria for Adverse Events (CTCAE v4.0) criteria.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study start7 Aug 2015
- Primary completionJun 2019
- Study completionJun 2019
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 (1)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 Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc.
- Responsible party
- Principal investigator, Jeremy Abramson, MD, Massachusetts General Hospital
- Investigators
- Jeremy Abramson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505269
- Sponsor's protocol ID
- 15-196
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2015
- Last updated
- 23 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Abramson JS, Bengston E, Redd R, Barnes JA, Takvorian T, Sokol L, Lansigan F, Armand P, Shah B, Jacobsen E, Martignetti R, Turba E, Metzler S, Patterson V, LaCasce AS, Bello CM. Brentuximab vedotin plus doxorubicin and dacarbazine in nonbulky limited-stage classical Hodgkin lymphoma. Blood Adv. 2023 Apr 11;7(7):1130-1136. doi: 10.1182/bloodadvances.2022008420.
PubMed 36053786