Lymphoma
Conditions
Keywords
recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
Brief summary
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and combination chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy followed by autologous hematopoietic stem cell transplantation in treating patients who have B-cell non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES: * Determine the levels of soluble CD20 antigen (sCD20) in the blood before and after treatment with rituximab and carmustine, cytarabine, etoposide, and melphalan followed by autologous hematopoietic stem cell transplantation in patients with CD20-positive B-cell non-Hodgkin's lymphoma. * Correlate the effect of changes in levels of sCD20 with clinical outcomes in patients treated with this regimen. * Determine the response rate in patients treated with this regimen. * Determine the event-free survival of patients treated with this regimen. * Determine the toxicity profile of this regimen in these patients. OUTLINE: Patients receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest. Patients then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6, cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplantation on day 0. Patients who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks. Patients are followed at day 100, at 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Interventions
BIOLOGICALrituximab
DRUGcarmustine
DRUGcytarabine
DRUGetoposide
DRUGmelphalan
PROCEDUREautologous bone marrow transplantation
PROCEDUREperipheral blood stem cell transplantation
Sponsors
National Cancer Institute (NCI)
University of Nebraska
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of non-Hodgkin's lymphoma o Any B cell * CD20-positive disease * Failed prior primary induction therapy * Meets 1 of the following criteria: * Chemotherapy-refractory disease * Received at least 3 prior chemotherapy regimens * Mantle cell lymphoma * Eligible for transplantation * 19 years old and over * WHO 0-2 * Life expectancy at least 6 months * Absolute neutrophil count ≥ 1,000/mm\^3\* * Platelet count \> 50,000/mm\^3\* * Hemoglobin \> 9.0 g/dL\* o NOTE: \*Unless due to lymphomatous involvement of the bone marrow * Fertile patients must use 2 methods of effective contraception
Exclusion criteria
* No history of T-cell lymphoma * Not pregnant or nursing * No other concurrent serious disease or condition that would preclude study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of the relationship between levels of sCD20 in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous peripheral blood progenitor cell transplantation (PBPCT) as they relate to clinical outcomes. | pre and post transplant | To evaluate levels of soluble CD20 antigen (sCD20) in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous hematopoietic stem cell transplantation (AHSCT), and to examine the effect of changes in levels of sCD20 with clinical outcomes. |
Countries
United States
Outcome results
None listed