Brentuximab Vedotin Plus AVD in Limited-stage Hodgkin Lymphoma
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/22/2018 |
| Start Date: | March 2012 |
| End Date: | January 2018 |
Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma
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.
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.
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
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
We found this trial at
4
sites
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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