High Dose Chemotherapy With Autologous Stem Cell Rescue for Aggressive B Cell Lymphoma and Hodgkin Lymphoma in HIV-infected Patients (BMT CTN 0803)
BACKGROUND:
Non-Hodgkin lymphoma (NHL) is an AIDS-defining diagnosis for patients infected with the
Human Immunodeficiency Virus (HIV). While the incidence of NHL has decreased amongst
HIV-infected patients since the advent of highly-active anti-retroviral therapy (HAART),
lymphoma remains a significant cause of death for this patient population. The prognosis for
patients with AIDS-related lymphoma is dramatically different in the era of HAART therapy.
In a comparison of treatment outcomes for patients treated before and after the advent of
HAART, there is a statistically significant improvement in the overall survival of patients
treated with HAART. Unfortunately, despite considerable advances in the treatment of
AIDS-related NHL, induction-failure and disease relapse remain key challenges. The
prognosis for patients with refractory and relapsed NHL is poor with overall survival rates
of less than 20 percent for patients treated with non-transplant salvage therapies. Based
upon a randomized trial and numerous phase II trials, high-dose therapy with autologous
hematopoietic cell transplantation (HCT) has been established as the standard of care for
patients with chemotherapy-sensitive relapsed non-Hodgkin lymphoma.
DESIGN NARRATIVE:
All patients must have chemosensitive disease as demonstrated by response to induction or
salvage chemotherapy. Patients must also have less than or equal to 10percent bone marrow
involvement after their most recent salvage therapy. Patients cannot have had prior
autologous or allogeneic HCT. Patients must initiate conditioning therapy within 3 months
of mobilization or bone marrow harvest.
Mobilization therapy may be employed per institutional guidelines. Patients must have an
adequate autograft to be eligible for the protocol. Patients may not have HIV refractory to
pharmacologic therapy. Patients must not have opportunistic infection that is not
responding to therapy. Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2
BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1
followed by autologous HCT.
Patients will be followed for 2 years post-transplant. Survival data, time to progression
data, progression-free survival data, time to progression after CR data, lymphoma
disease-free survival data, time to hematopoietic recovery data, hematologic function data,
toxicity data, incidence of infections, treatment-related mortality data, immunologic
reconstitution data, data assessing the impact of therapy on the HIV reservoir and microbial
gut translocation will be recorded and reported periodically to the BMT CTN Data and
Coordinating Center (DCC).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival
Assess the overall survival after autologous hematopoietic stem cell transplantation (HCT) for chemotherapy-sensitive aggressive B cell lymphoma or Hodgkin's lymphoma in patients with HIV using BEAM for pre-transplant conditioning
1 year
Yes
Joseph Alvarnas, MD
Study Chair
City of Hope National Medical Center
United States: Federal Government
698
NCT01141712
February 2011
June 2015
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University Hospitals of Cleveland | Cleveland, Ohio 44106 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
City of Hope National Medical Center | Los Angeles, California 91010 |
University of Rochester | Rochester, New York 14642 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
Emory University | Atlanta, Georgia 30322 |
Ohio State University Medical Center | Columbus, Ohio 43210 |
University of Texas, MD Anderson Cancer Center | Houston, Texas 77030 |
Weill Cornell Medical College | New York, New York 10021 |
BMT Program at Northside Hospital | Atlanta, Georgia 30342 |
University of Florida College of Medicine | Gainesville, Florida 32610 |
University of California San Diego Medical Center | San Diego, California 92103-8409 |
Johns Hopkins Medical Institution | Baltimore, Maryland 21205 |
UCLA, Center for Clinical AIDS Research and Education | Los Angeles, California 90035 |
University of Maryland Medical Systems, Greenebaum Cancer Center | Baltimore, Maryland 21201 |
University of Washington, Barnes Jewish Hospital | St. Louis, Missouri 63110 |