Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma

NCT ID: NCT01534078

Last Updated: 2018-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2018-01-31

Brief Summary

Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell.

The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you will receive in this research study are approved for use in people with Hodgkin Lymphoma. A drug called bleomycin is usually included with AVD, but since it appears to be a less effective drug with significant potential risks, it is being replaced in this study with the drug brentuximab.

In this research study, the investigators are looking to see whether brentuximab in combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.

Detailed Description

Each treatment cycle is 28 days. You will receive brentuximab alone on Day 1 and 15 of the first cycle (lead-in cycle). After cycle 1, you will receive brentuximab combined with AVD on Day 1 and 15 for 4-6 cycles, depending on your response to therapy. Brentuximab and AVD will be given to you by intravenous infusion (IV).

The following test and procedures will be performed on Days 1 and 15 of each cycle:

• Review of any side effects you have experienced and all medications you are taking
• Performance Status
• Physical exam and vital signs
• Routine blood tests
• Questionnaire to evaluate symptoms of neuropathy
• Research blood sample to look at markers to see how your body is responding to study medication
• PET-CT scan prior to completing cycle 2 of combination brentuximab/AVD

After the final dose of the study drug: The following assessments will be performed within one month of your last dose of study medication:

• Review of any side effects you have experienced and all medications you are taking
• Performance Status
• Physical exam and vital signs
• Routine blood tests
• Questionnaire to evaluate symptoms of neuropathy
• Research blood sample to look at markers to see how your body is responding to study medication
• PET-CT scan Follow up will include the following
• Review of any side effects you have experienced and all medications you are taking
• Performance Status
• Review and Physical exam
• Routine blood tests
• Questionnaire to evaluate symptoms of neuropathy
• CT scans

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine

Group Type: EXPERIMENTAL

Brentuximab Vedotin

Intervention Type: DRUG

2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg

Adriamycin, vinblastine, and dacarbazine

Intervention Type: DRUG

Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine

Interventions

Brentuximab Vedotin

2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg

Intervention Type: DRUG

Adriamycin, vinblastine, and dacarbazine

Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine

Intervention Type: DRUG

Other Intervention Names

Adcetris; SGN-35; SGN35; Doxorubicin; Velban; DTIC

Eligibility Criteria

Inclusion Criteria

• Previously untreated stage IA, IB, IIA or IIB classical Hodgkin Lymphoma
• Non-bulky disease defined as less than 10 cm in maximal diameter
• Measurable disease greater than or equal to 1.5 cm
• ECOG performance status of 0 or 2
• Willing to use 2 effective forms of birth control

Exclusion Criteria

• No prior chemotherapy or radiotherapy for Hodgkin lymphoma
• Not receiving any other investigational agents
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Adriamycin, Vinblastine, Dacarbazine or brentuximab
• No pre-existing grade 3 or greater neuropathy
• No uncontrolled intercurrent illness
• Not pregnant or breastfeeding
• No history of a different malignancy unless disease free for at least one year

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: collaborator

Seagen Inc.

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeremy Abramson, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeremy Abramson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Moffitt Cancer Center

Tampa, Florida, United States

Massachusetts General Hosptial

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

References

Abramson JS, Arnason JE, LaCasce AS, Redd R, Barnes JA, Sokol L, Joyce R, Avigan D, Neuberg D, Takvorian RW, Hochberg EP, Bello CM. Brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine for nonbulky limited-stage classical Hodgkin lymphoma. Blood. 2019 Aug 15;134(7):606-613. doi: 10.1182/blood.2019001272. Epub 2019 Jun 11.

Reference Type: DERIVED

PMID: 31186274 (View on PubMed)

Other Identifiers

11-462

Identifier Type: -

Identifier Source: org_study_id