Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma
18 Years
N/A
Both
Hodgkin Lymphoma
Trial Information
Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Investigate clinical activity of Brentuximab w/AVD in cHL
Outcome Description:
Primary clinical endpoint is complete remission rate measured by PET/CT. Overall response rate, Failure-free survival and overall survival will also be assessed.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Jeremy Abramson, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Food and Drug Administration
Study ID:
11-462
NCT ID:
NCT01534078
Start Date:
March 2012
Completion Date:
Related Keywords:
- Hodgkin Lymphoma
- non-bulky
- limited stage
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Moffitt Cancer Center | Tampa, Florida 33612 |
| Massachusetts General Hosptial | Boston, Massachusetts 02114 |
