Clinical trial NCT01534078: Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma
Official title: Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Keywords: non-bulky
limited stage
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Dana-Farber Cancer Institute
name: H. Lee Moffitt Cancer Center and Research Institute
name: Seagen Inc.
First posted: 2012-02-16
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Complete Response Rate
timeFrame: End of Therapy (median duration of four months)
Secondary outcomes:
measure: Overall Response Rate After One Cycle of Brentuximab
timeFrame: 28 days
measure: Overall Response Rate
timeFrame: End of Therapy (median duration of four months)
measure: Grade III or IV Adverse Events
timeFrame: 2 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hosptial
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeremy Abramson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.