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Study Title: AMC047: AIDS-Associated B-Cell Non-Hodgkin's Lymphoma
Category: Cancer, General
Currently accepting participants?
Yes - please read the description below and contact the study coordinator if you are interested.
Principal Investigator: David Aboulafia
Study Coordinator: Cara Aeschliman
Phone: 206.625.7373 Ext.61870
Email: cara.aeschliman@vmmc.org
What is the AMC047: AIDS-Associated B-Cell Non-Hodgkin's Lymphoma study?
The purpose of this study is to see how well Doxil and Rituximab work in combination with Cyclophosphamide, Vincristine, and Prednisone (DR-COP) in shrinking tumors in patients with AIDS-related Non-Hodgkin's Lymphoma.
Each cycle of Doxil, Rituximab, Cyclophosphamide, Vincristine, and Prednisone (DR-COP) will be repeated every 21 to 28 days, for a maximum of 8 cycles. Once treatment is complete, you will be asked to return for follow-up visits for up to 2 years.
Who can participate?
Basic Inclusion/Exclusion Criteria:
• HIV positive adults.
• Previously untreated B-cell NHL (follicular large-cell (Grade 3), DLBCL, immunoblastic lymphoma, plasmablastic lymphoma, or primary effusion lymphoma). All stages of disease.
• Lymphoma must be CD20+.
• Adequate hepatic, renal, cardiac, pulmonary, and hematologic function.
• Negative pregnancy test and no nursing mothers. Men and women must agree to use contraception.
• Concurrent radiation for emergency conditions secondary to lymphoma will be permitted.
• Concurrent effective HAART treatment of HIV is required at study entry.
• Patients already receiving erythropoietin or G-CSF are eligible for participation, although GF therapy must be discontinued at least 24-hours prior to receiving chemotherapy.
• Able to give signed informed consent.
• No prior cytotoxic chemotherapy or radiotherapy for this lymphoma, or rituximab therapy wihin 12 months.
• No presence of a second active tumor, other than non-melanomatous skin cancer, carcinoma in situ of the cervix, or Kaposi’s sarcoma (KS) that does not require systemic therapy.
What do I have to do as a study participant?
Study Summary:
AIDS-Associated B-Cell Non-Hodgkin's Lymphoma
Detailed Study Description:
(No information)
Study Design: Interventional
Phase of Study: Phase II
Study Type: Interventional
Condition or Study Focus: AIDS, B-Cell Non-Hodgkin's Lymphoma
Intervention Type: chemotherapy
Intervention Name: Doxil, Rituximab, Cyclophosphamide, Vincristine, and Prednisone (DR-COP)
Gender: Male and Female
Age group: Interventional
Sponsor: AIDS Malignancy Consortium (AMC)
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