Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma

Mass General Brigham

Status and phase

Completed

Phase 2

Conditions

Hodgkin Lymphoma

Treatments

Drug: Brentuximab Vedotin

Drug: Adriamycin, vinblastine, and dacarbazine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01534078

11-462

Details and patient eligibility

About

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.

Full 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

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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