Blood and Marrow Transplant Clinical Trials Network (BMT CTN) High Dose Chemotherapy With Autologous Stem Cell Rescue for Aggressive B Cell Lymphoma and Hodgkin Lymphoma in HIV-infected Patients (0803)
Note that you will be prompted to log in or register an account
Open BioLINCC Study See bottom of this webpage for request information
April 2010 – June 2016
January 14, 2019
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Specific Consent Restrictions
To evaluate the effectiveness of autologous hematopoietic cell transplantation (AHCT) for HIV positive patients with chemotherapy-sensitive aggressive B cell lymphoma or Hodgkin’s HIV-Related Lymphoma (HRL) who received carmustine, etoposide, cytarabine, and melphalan (BEAM) as the pre-transplant conditioning regimen.
Patients with HIV have an increased risk for developing cancer, including Hodgkin and non-Hodgkin lymphoma. For most patients with chemotherapy-sensitive relapsed and persistent lymphoma, autologous hematopoietic cell transplantation (AHCT) has been the standard of care, but for many years, was contraindicated for HIV patients. This was due to the immunosuppressive qualities of the chemotherapeutic agents used in the pre-transplantation procedure. With the advent of combination anti-retroviral therapy (cART), HIV infected patients became less susceptible to opportunistic infections making them better candidates to receive AHCT. In the late 1990s, the use of AHCT was introduced for patients with high-risk, relapsed, and persistent HRL with favorable outcomes.
Forty-three participants were enrolled into the study. Participants were eligible if they were at least 15 years old, infected with HIV, and the HIV was responsive to pharmacological therapy. Participants were also required to have persistent or recurrent diffuse large B-cell, immunoblastic, plasmablastic, Burkitt or Burkitt-like non-Hodgkin lymphoma or classical Hodgkin lymphoma. Eligible participants also needed to have a Karnofsky performance status >70%, adequate organ function, and no prior history of autologous or allogeneic HCT.
Patients had to initiate their conditioning regimen within 3 months of mobilization or bone marrow harvest. Hematopoietic progenitor cell (HPC) mobilization was per institutional standards and patients were required to achieve adequate HPC mobilization (> 1.5 x 10^6 CD34+ cells/kg) to be eligible for the protocol.
This was a prospective phase II multicenter trial where eligible participants received a modified BEAM treatment prior to the AHCT. The BEAM regimen consisted of carmustine 300 mg/m2 (day – 6), etoposide 100 mg/m2 twice daily (days −5 to −2), cytarabine 100 mg/m2 twice daily (days −5 to −2), and melphalan 140 mg/m2 (day −1). cART was held from the time of initiation of the BEAM regimen and resumed at least 7 days after completion of the preparative regimen or following recovery from transplant-related gastrointestinal toxicities.
Patients underwent AHCT on day 0 and received growth factor, transfusion, and antimicrobial supportive care per the respective institutional standard through the period of post-AHCT recovery.
The primary endpoint was 1-year overall survival after AHCT.
Participant outcomes in this study were compared with 151 matched Center for International Bone Marrow Transplant Research controls. Outcomes between HIV-infected patients and controls were not significantly different. Based on these results, HRL patients should be considered candidates for AHCT if they meet standard transplant criteria.
Alvarnas JC, Le Rademacher J, Wang Y, et al. Autologous hematopoietic cell transplantation for HIV-related lymphoma: results of the BMT CTN 0803/AMC 071 trial. Blood. 2016;128(8):1050-8.
Please note that researchers must be registered on this site to submit a request, and you will be prompted to log in. If you are not registered on this site, you can do so via the Request button. Registration is quick, easy and free.
Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 406.9 KB)
- BMT CTN 0803 Case Report Forms (PDF - 723.4 KB)
- BMT CTN 0803 Protocol (PDF - 1.2 MB)
Persons using assistive technology may not be able to fully access information in the study documents. For assistance, Contact BioLINCC and include the web address and/or publication title in your message. If you need help accessing information in different file formats such as PDF, XLS, DOC, see Instructions for Downloading Viewers and Players.