Phase II R-ABVD Versus ABVD for Advanced Stage Classical Hodgkin Lymphoma
Summary
The goal of this clinical research study is to compare the effectiveness of receiving Adriamycin (doxorubicin hydrochloride), bleomycin, vinblastine, and dacarbazine (ABVD) therapy alone to receiving ABVD with rituximab.
Description
The Study Drugs:
ABVD is a combination of chemotherapy drugs and is made up of doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine. The combination of drugs is designed to stop the growth of cancer cells, which may cause the cells to die.
Rituximab is designed to attach to cancer cells, which may cause them to die.
Study Groups:
If you are eligible to take part in this study, you will be randomly assigned (like the flip of a coin) to 1 of 2 treatment "groups". If you are in Group 1, you will receive ABVD with rituximab. If you are in Group 2, you will receive ABVD. No matter which group you are assigned to, the doses of the drugs will be the standard doses that are currently used to treat lymphoma.
Group 1:
If you are assigned to Group 1, you will receive the ABVD combination through a needle in your vein for about 1 hour on Day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks.
You will also receive rituximab by vein for about 7 hours on Days 1, 8 ,15 and 22 (once a week) of Cycle 1. For Cycle 1 only, if there is not enough time for both ABVD and Rituximab to be given on Day 1, you may receive Rituximab on Day 2. For Cycle 2, you will receive rituximab on Days 1 and 8 only. You will only take rituximab for the first 2 cycles.
Group 2:
If you are assigned to Group 2, you will receive the ABVD combination through a needle in your vein for about 1 hour on Day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. You will not receive rituximab.
Study Visits:
While on study you will have tests and procedures performed at certain times and when the study doctor thinks it may be necessary. The following tests and procedures will be performed:
- On Day 1 and 15 of each cycle, blood (about 3-4 teaspoons) will be drawn for routine tests.
- After every 4 doses of ABVD, you will also have a chest x-ray and CT scans of the neck, chest, abdomen, and pelvis.
- If your first PET scan showed lymphoma in your body, you will have a PET scan after every 4 doses of ABVD until the PET scan shows that there is no more lymphoma tumors in your body.
Length of Study:
You will remain on study for up to 6 cycles (23 weeks). You will be taken off study early if the disease gets worse, you start a new treatment for the cancer, or you experience intolerable side effects.
End-of-Treatment Visit:
Before you are taken off study, you will have an end-of-study visit. The following tests and procedures will be performed:
- You will have a physical exam.
- Your complete medical history will be recorded.
- Blood (about 3-4 teaspoons) will be drawn for routine tests.
- You will also have a chest x-ray and CT scans of the neck, chest, abdomen, and pelvis to check on the size and locations of the cancer.
- If your first PET scan showed lymphoma in your body, you will have a PET scan.
Follow-up Visits:
After your last study visit, you will return for follow up visits every 3 months during Year 1, every 4 months during Year 2, every 6 months during Years 3-5, and then once a year to check on the status of the disease. At these visits, the following tests and procedures will be performed:
- You will have a physical exam.
- Your complete medical history will be recorded.
- Blood (about 3-4 teaspoons) will be drawn for routine tests.
- You will also have a chest x-ray and CT scans of the neck, chest, abdomen, and pelvis to check on the size and locations of the cancer.
- If your first PET scan showed lymphoma in your body, you will have a PET scan.
About 2 weeks after your last dose of the study drug(s), if there were lymphoma cells in your first bone marrow aspiration and biopsy, you will have a bone marrow aspiration and biopsy to check the status of the disease.
This is an investigational study. The ABVD combination is FDA approved and commercially available for patients with Hodgkin's disease. Rituximab is FDA approved and commercially available. The combination of ABVD with rituximab is considered investigational. Up to 120 patients will take part in this study. Up to 70 will be enrolled at M. D. Anderson.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Hodgkin Lymphoma
Intervention
Rituximab, Adriamycin, Bleomycin, Vinblastine, Dacarbazine
Location
University of Miami
Coral Gables
Florida
United States
33124
Status
Recruiting
Source
M.D. Anderson Cancer Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00654732
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Composite Lymphoma
Two or more distinct types of malignant lymphoid tumors occurring within a single organ or tissue at the same time. It may contain different types of non-Hodgkin lymphoma cells or both Hodgkin and non-Hodgkin lymphoma cells.
Lymphoma, Mantle-cell
A form of non-Hodgkin lymphoma having a usually diffuse pattern with both small and medium lymphocytes and small cleaved cells. It accounts for about 5% of adult non-Hodgkin lymphomas in the United States and Europe. The majority of mantle-cell lymphomas are associated with a t(11;14) translocation resulting in overexpression of the CYCLIN D1 gene (GENES, BCL-1).
Lymphoma, Non-hodgkin
Any of a group of malignant tumors of lymphoid tissue that differ from HODGKIN DISEASE, being more heterogeneous with respect to malignant cell lineage, clinical course, prognosis, and therapy. The only common feature among these tumors is the absence of giant REED-STERNBERG CELLS, a characteristic of Hodgkin's disease.
Lymphomatoid Papulosis
Clinically benign, histologically malignant, recurrent cutaneous T-cell lymphoproliferative disorder characterized by an infiltration of large atypical cells surrounded by inflammatory cells. The atypical cells resemble REED-STERNBERG CELLS of HODGKIN DISEASE or the malignant cells of CUTANEOUS T-CELL LYMPHOMA. In some cases, lymphomatoid papulosis progresses to lymphomatous conditions including MYCOSIS FUNGOIDES; HODGKIN DISEASE; CUTANEOUS T-CELL LYMPHOMA; or ANAPLASTIC LARGE-CELL LYMPHOMA.
Lymphoma, Large-cell, Anaplastic
A systemic, large-cell, non-Hodgkin, malignant lymphoma characterized by cells with pleomorphic appearance and expressing the CD30 ANTIGEN. These so-called "hallmark" cells have lobulated and indented nuclei. This lymphoma is often mistaken for metastatic carcinoma and MALIGNANT HISTIOCYTOSIS.
Clinical Trials
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PubMed Articles
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Adolescents with Hodgkin lymphoma - old children or young adults?
Abstract Hodgkin lymphoma (HL) is a malignancy of the lymphatic system with an incidence of 2-3/100.000/year in Europe and North America. The disease generally occurs in all age groups but young adu...
ABVD versus BEACOPP for Hodgkin's lymphoma when high-dose salvage is planned.
BEACOPP, an intensified regimen consisting of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone, has been advocated as the new standard of treatment for ad...
Abstract The role of dacarbazine in ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) therapy in Hodgkin lymphoma (HL) remains unclear. This phase II study assessed the efficacy and safety o...
Prognostic impact of bleomycin-induced pneumonitis on the outcome of Hodgkin's lymphoma.
Bleomycin-induced pneumonitis (BIP) has been well described in Hodgkin's lymphoma (HL) patients. The impact of BIP on patients uniformly treated with adriamycin, bleomycin, vinblastine, and dacarbazin...
