Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma
The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4 chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine). The number of cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In addition to the ABVD chemotherapy, patients with Hodgkin lymphoma will routinely receive radiation therapy. The use of chemotherapy and radiation may cause long term treatment related side effects such as heart problems and other cancers. Researchers are trying to find if combining ABVD chemotherapy with new drugs and reducing the number of ABVD chemotherapy cycles given is just as effective as the standard Hodgkin treatment.
Brentuximab vedotin is approved by the United States Food and Drug administration (FDA) for the treatment of Hodgkin lymphoma that has come back (relapsed). For this research study, the use of brentuximab vedotin in newly diagnosed Hodgkin lymphoma is considered investigational. Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it. Antibodies are proteins that are part of your immune system. They can stick to and attack specific targets on cells. The antibody part of the brentuximab vedotin sticks to a target called cluster of differentiation antigen 30 (CD30). CD30 is an important molecule on some cancer cells and some normal cells of the immune system.
The purpose of this research study is to see the effects of treatment with fewer cycles of the combination chemotherapy, ABVD, followed by the study drug brentuximab vedotin has on study participants and Hodgkins lymphoma.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||LCCC 1115: A Pilot Feasibility Trial of Induction Chemotherapy With ABVD Followed by Brentuximab Vedotin (SGN-35) Consolidation in Patients With Previously Untreated Non-Bulky Stage I or II Hodgkin Lymphoma (HL)|
- PET Negative Disease [ Time Frame: 12 months ]Percentage of patients who convert to PET negative disease post consolidation.
- Response Rate [ Time Frame: 12 months ]Response criteria based on the International Workshop to standardize response criteria for malignant lymphomas
- Conversion rate to Complete Response [ Time Frame: 12 months ]Conversion rate to Complete Response after brentuximab vedotin in patients with partial response at the end of ABVD therapy.
- Progression Free Survival [ Time Frame: 5 years ]Defined as the time from ABVD treatment start until disease progression or death from any cause.
- Time to Progression [ Time Frame: 5 years ]Defined as the time from ABVD treatment initiation until the time of disease progression or death due to progressive disease.
- Toxicity [ Time Frame: 12 months ]Toxicity assessed via the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4
- Exploratory Objective whether the cytokine profile changes after treatment [ Time Frame: 12 months ]To determine whether the cytokine profile changes after treatment, and to correlate serum levels of cytokines with the overall response after ABVD followed by brentuximab vedotin consolidation
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||August 10, 2021|
|Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
ABVD followed by Brentuximab vedotin
Single arm trial
Drug: Brentuximab vedotin
IV, 1.8mg/kg, every 3 weeks for 6 cycles.
Other Names:Drug: ABVD
Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
This study is designed as a single arm pilot feasibility trial using an induction of 2-6 cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) chemotherapy followed by 6 cycles of brentuximab vedotin (SGN-35) consolidation for previously untreated patients with stage I and II non-bulky Hodgkin Lymphoma (HL).
Feasibility will be determined by the percentage of patients who have no clinical evidence of HL, and achieve positron emission tomograph (PET) negative disease post brentuximab consolidation. We anticipate approximately 40 patients will be eligible across participating centers (including UNC, Mayo Clinic, and the UNC Cancer Network (UNCCN)) over a 2 year period. A future phase II study evaluating progression free survival (PFS) after ABVD followed by brentuximab vedotin will be considered feasible if ≥ 13 of 15 patients enrolled in this pilot trial become PET negative after brentuximab vedotin consolidation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578967
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, North Carolina|
|University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|Levine Cancer Istitute, Carolinas Health Care system|
|Charlotte, North Carolina, United States, 28204|
|Rex Cancer Center|
|Raleigh, North Carolina, United States, 27607|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37240|
|Principal Investigator:||Thomas Shea, MD||UNC Lineberger Comprehensive Cancer Center|