This research study is being conducted to treat patients with B-cell lymphoid malignancies. These types of cancers include diffuse large cell (DLBCL) non-Hodgkin's lymphoma (NHL), mantle cell NHL, any indolent B cell NHL (such as follicular, small cell or marginal zone NHL), or chronic lymphocytic leukemia (CLL). Patients with these types of lymphomas have been shown to benefit from peripheral blood stem cell transplantation (PBSCT). PBSCT uses healthy blood stem cells from a donor to replace your diseased or damaged bone marrow. Before undergoing PBSCT, you'll receive chemotherapy and/or radiation to destroy your diseased cells and prepare your body for the donor cells. This is called a "conditioning regimen." Non-myeloablative (NMA) conditioning causes minimal cell death. This research study will look at a course of treatment using NMA conditioning regimen including low dose chemotherapy and low dose radiation as well as rituximab and PBSCT from a compatible donor. The primary aim is to obtain a preliminary estimate of the overall and event-free survival 1 year post-transplant after NMA.
This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLBCLC) and mantle cell non-Hodgkin's lymphoma (MCL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL). The study design will be based on a total of 90 patients, 30 recipients of related matched and 60 recipients of mismatched related or unrelated PBSCT. It is anticipated that the accrual will last 5-6 years. At the conclusion of the study, the safety and a preliminary assessment of efficacy of NMA PBSCT will be determined. The treatment will be declared efficacious if the disease-free survival at 1 year in this patient population is at least 50%.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
NMA PBSCT (Non-Myeloablative peripheral blood stem cell transplantation) incorporating rituximab and utilizing PBSC (Peripheral blood stem cells) to increase graft cell dose in patients with selected B lymphoid malignancies.
NMA PBSCT (Non-Myeloablative peripheral blood stem cell transplantation) incorporating rituximab and utilizing PBSC (Peripheral blood stem cells) to increase graft cell dose in patients with selected B lymphoid malignancies.
Miami Cancer Institute at Baptist Health of South Florida
Miami, Florida, United States
Estimate the overall and event-free survival
The primary aim of this study is to obtain a preliminary estimate of the overall and event-free survival at 1 year after NMA PBSCT with peri-transplant rituximab using an HLA matched or single HLA allele disparate related or unrelated donors
Time frame: 1 year
Speed of Recovery Post Allograft
the speed of neutrophil and platelet recovery post allograft
Time frame: 100 days
Response to Engraftment
the incidence and speed of donor-derived engraftment
Time frame: 100 days
Status of Graft Versus Host Disease
The incidence and severity of acute GVHD(Graft Versus Host Disease) at 100 days
Time frame: 100 days
Number of Participants with Graft Versus Host Disease
The incidence and severity of chronic GVHD (Graft Versus Host Disease) at 1 year
Time frame: 1 year
Number of Participants with Complications
the incidence of serious infectious complications with their correlation with laboratory measurements of immune recovery
Time frame: 100 days
Response Rate to Vaccination
the response to vaccination after PBSCT (Peripheral Blood Stem Cells Transplantation)
Time frame: 100 days
Number of Transplant Related Mortality Incidences
the incidence of Transplant Related Mortality at 100 and 180 days
Time frame: 100 and 180 days
Number of Relapse or Disease Progression Instances
the incidence of malignant relapse or disease progression at 1 and 2 years
Time frame: 1 and 2 years
Number of Overall and Event Free Survival
the probabilities of overall and event-free survival at 2 years after Peripheral Blood Stem Cells Transplantation
Time frame: 2 years
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