Autologous hematopoietic cell transplantation for HIV-related lymphoma: results of the BMT CTN 0803/AMC 071 trial.
Autologous hematopoietic cell transplant (AHCT) for HIV-infected patients is largely limited to centers with HIV-specific expertise. The Blood and Marrow Transplant Clinical Trials Network 0803/AIDS Malignancy Consortium 071 trial is a multicenter phase 2 study of AHCT for patients with HIV-related lymphoma (HRL). Eligible patients had chemotherapy-sensitive relapsed/persistent HRL, were >15 years of age, and had treatable HIV infection. Patients were prepared using carmustine, etoposide, cytarabine, and melphalan and received consistent management of peritransplant antiretroviral treatment. The primary endpoint was 1-year overall survival. Forty-three patients were enrolled; 40 underwent AHCT. Pretransplant HIV viral load was undetectable (<50 copies/mL) in 32 patients (80%); the median CD4 count was 249/μL (range, 39-797). At a median follow-up of 24.8 months, 1-year and 2-year overall survival probabilities were 87.3% (95% confidence interval [CI], 72.1-94.5) and 82% (95% CI, 65.9-91), respectively. The probability of 2-year progression-free survival was 79.8% (95% CI, 63.7-89.4). One-year transplant-related mortality was 5.2%. Median time to neutrophil and platelet recovery was 11 days and 18 days, respectively. Nine patients experienced a total of 13 unexpected grade 3-5 adverse events posttransplant (10 grade 3 and 3 grade 4 events). Twenty-two patients had at least 1 infectious episode posttransplant. At 1 year post-AHCT, median CD4(+) T-cell count was 280.3 (range, 28.8-1148.0); 82.6% had an undetectable HIV viral load. Trial patients were compared with 151 matched Center for International Bone Marrow Transplant Research controls. Outcomes between HIV-infected patients and controls were not statistically significantly different. HRL patients should be considered candidates for AHCT if they meet standard transplant criteria. The trial was registered at www.clinicaltrials.gov as #NCT01141712.
Department of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA;
Joseph C
JC
Alvarnas
Center for International Blood & Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI;
Jennifer
J
Le Rademacher
The Emmes Corporation, Rockville, MD;
Yanli
Y
Wang
Cancer Therapy Evaluation Program, National Cancer Institute, Rockville, MD;
Richard F
RF
Little
Greenebaum Cancer Center, University of Maryland Medical Systems, Baltimore, MD;
Gorgun
G
Akpek
Department of Blood and Marrow Transplantation, H. Lee Moffitt Cancer Center, Tampa, FL;
Ernesto
E
Ayala
Department of Hematology, The Ohio State University-Arthur G. James Cancer Center Hospital, Columbus, OH;
Steven
S
Devine
Department of Hematology, The Ohio State University-Arthur G. James Cancer Center Hospital, Columbus, OH;
Robert
R
Baiocchi
Department of Hematology, The Ohio State University-Arthur G. James Cancer Center Hospital, Columbus, OH;
Gerard
G
Lozanski
Division of Hematology/Oncology, University of California, San Francisco, CA;
Lawrence
L
Kaplan
Division of Hematological Oncology, Memorial Sloan Kettering Cancer Center, New York, NY;
Ariela
A
Noy
Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX;
Uday
U
Popat
Bone Marrow Transplant Program, University of Florida Health Cancer Center, Gainesville, FL;
Jack
J
Hsu
The Blood and Marrow Transplant Group of Georgia, Northside Hospital Cancer Institute, Atlanta, GA;
Lawrence E
LE
Morris
The Emmes Corporation, Rockville, MD;
Jason
J
Thompson
Center for International Blood & Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI;
Mary M
MM
Horowitz
The Emmes Corporation, Rockville, MD;
Adam
A
Mendizabal
City of Hope National Medical Center, Duarte, CA;
Alexandra
A
Levine
Department of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA;
Amrita
A
Krishnan
Department of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA;
Stephen J
SJ
Forman
National Marrow Donor Program, Minneapolis, MN; and.
Willis H
WH
Navarro
Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD.
Richard
R
Ambinder
D000328:Adult; D016026:Bone Marrow Transplantation / Q000009:adverse effects / Q000401:mortality; D018791:CD4 Lymphocyte Count; D019992:Databases as Topic; D003710:Demography; D018572:Disease-Free Survival; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000401:mortality; D006801:Humans; D016483:Lymphoma, AIDS-Related / Q000276:immunology / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D014182:Transplantation, Autologous / Q000009:adverse effects; D016896:Treatment Outcome; D019562:Viral Load / Q000276:immunology; D055815:Young Adult