Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma

Phase 2

Completed

Conditions: Hodgkin Lymphoma

Interventions: Drug: Brentuximab Vedotin
Drug: Adriamycin, vinblastine, and dacarbazine

Registration Number: NCT01534078

Lead Sponsor: Massachusetts General Hospital

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Adriamycin, vinblastine, and dacarbazine	Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
Treatment Arm	Brentuximab Vedotin	Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine

Primary Outcome Measures

Name	Time	Method
Complete Response Rate	End of Therapy (median duration of four months)	Complete response rate at the end of therapy as measured by Positron emission tomography-computed tomography (PET/CT). Response is evaluated using Revised International Working Group Criteria. Complete response is defined as disappearance of all evidence of disease.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate After One Cycle of Brentuximab	28 days	The number of participants achieving a Partial Response (PR) or Complete Response (CR) after one cycle of Brentuximab monotherapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria. * CR: Disappearance of all evidence of disease * PR: Regression of measurable disease and no new sites
Overall Response Rate	End of Therapy (median duration of four months)	The number of participants achieving a Partial Response (PR) or Complete Response (CR) at the end of therapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria. * CR: Disappearance of all evidence of disease * PR: Regression of measurable disease and no new sites
Grade III or IV Adverse Events	2 years	A summary of the grade 3 or 4 adverse events experienced by participants as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The data is shown as the number of participants that experienced at least one grade 3 or 4 adverse event for each of the specified toxicities.

Trial Locations

Locations (4): Massachusetts General Hosptial
🇺🇸
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Moffitt Cancer Center
🇺🇸
Tampa, Florida, United States