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Brentuximab Vedotin Plus AD in Non-bulky Limited Stage Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02505269
Recruitment Status : Completed
First Posted : July 22, 2015
Last Update Posted : June 12, 2018
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Jeremy Abramson, MD, Massachusetts General Hospital

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: Brentuximab Vedotin Drug: Adriamycin Drug: Dacarbazine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brentuximab Vedotin Plus AD in Non-bulky Limited Stage Hodgkin Lymphoma
Actual Study Start Date : August 7, 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Brentuximab Vedotin

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
Drug: Brentuximab Vedotin
Other Name: Adcetris

Drug: Adriamycin
Other Names:
  • Doxorubicin
  • Rubex ®

Drug: Dacarbazine
Other Names:
  • DTIC-Dome®
  • DTIC
  • DIC
  • Imidazole Carboxamide

Primary Outcome Measures :
  1. Complete Response Rate [ Time Frame: 4-6 months ]

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 4-6 months ]
    Kaplan-Meier method

  2. Rate of grade III and IV adverse events [ Time Frame: 4-6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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:

    • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02505269

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Seattle Genetics, Inc.
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Principal Investigator: Jeremy Abramson, MD Massachusetts General Hospital

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Responsible Party: Jeremy Abramson, MD, Principal Investigator, Massachusetts General Hospital Identifier: NCT02505269     History of Changes
Other Study ID Numbers: 15-196
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Keywords provided by Jeremy Abramson, MD, Massachusetts General Hospital:
limited stage
Hodgkin's disease

Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Antibodies, Monoclonal
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs