Overview

This trial is active, not recruiting.

Condition hodgkin lymphoma
Treatments brentuximab vedotin, adriamycin, vinblastine, and dacarbazine
Phase phase 2
Sponsor Massachusetts General Hospital
Collaborator Beth Israel Deaconess Medical Center
Start date March 2012
End date December 2016
Trial size 34 participants
Trial identifier NCT01534078, 11-462

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
brentuximab vedotin Adcetris
2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
adriamycin, vinblastine, and dacarbazine Doxorubicin
Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine

Primary Outcomes

Measure
Investigate clinical activity of Brentuximab w/AVD in cHL
time frame: 2 years

Secondary Outcomes

Measure
Estimate clinical activity of Brentuximab after one cycle
time frame: 2 years
Safety and Tolerability of Brentuximab
time frame: 2 years
Correlation of serum soluble CD30 and/or TARC and clinical response
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma
Principal investigator Jeremy Abramson, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.