Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534078
• Other study ID #: 11-462
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2012
• Last updated: January 23, 2018
• Start date: March 2012
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2018
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Drug:
• Brentuximab Vedotin
2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
• Adriamycin, vinblastine, and dacarbazine
Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hosptial	Boston	Massachusetts
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute, H. Lee Moffitt Cancer Center and Research Institute, Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate	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.	End of Therapy (median duration of four months)
Secondary	Overall Response Rate After One Cycle of Brentuximab	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	28 days
Secondary	Overall Response Rate	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	End of Therapy (median duration of four months)
Secondary	Grade III or IV Adverse Events	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.	2 years