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

NCT02505269 | Completed Phase 2 Results DMC

• 1 other identifier: 15-196
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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).

Conditions

Hodgkin Lymphoma

Keywords

limited stage; Hodgkin's disease; non-bulky

Outcome Measures

Primary Outcomes (1)

• 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: 1. No Uptake 2. Uptake ≤ mediastinum 3. Uptake \>mediastinum but ≤ liver 4. Uptake moderately increased compared to liver at any site 5. Uptake markedly increased compared to the liver at any site or/and new sites of disease

  4-6 months

Secondary Outcomes (2)

• Overall Response Rate

  4-6 months

• Number of Patients With Grade III and IV Adverse Events

  4-6 months

Study Arms (1)

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

Drug: Brentuximab Vedotin; Drug: Adriamycin; Drug: Dacarbazine

Interventions

Brentuximab Vedotin DRUG

Also known as: Adcetris

Brentuximab Vedotin

Adriamycin DRUG

Also known as: Doxorubicin, Rubex ®

Brentuximab Vedotin

Dacarbazine DRUG

Also known as: DTIC-Dome®, DTIC, DIC, Imidazole Carboxamide

Brentuximab Vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Seagen Inc.: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 36053786 DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Brentuximab Vedotin; Doxorubicin; Dacarbazine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jeremy Abramson
• Organization: Massachusetts General Hospital

JABRAMSON@mgh.harvard.edu

617-724-4000

Study Officials

• Jeremy Abramson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 22, 2015
• Study Start: August 7, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 24, 2020
• Results First Posted: August 24, 2020

Record last verified: 2020-08

Locations

US (2)