This pilot phase I trial studies the side effects of engineered donor stem cell transplant in treating patients with hematologic malignancies. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Using T cells specially selected from donor blood in the laboratory for transplant may stop this from happening.
PRIMARY OBJECTIVE: I. To assess the safety of a modified peripheral blood (PB) graft for haploidentical transplantation, obtained by using depletion of naive, cluster of differentiation (CD)45RA+ T cells. SECONDARY OBJECTIVES: I. To estimate the proportion of patients with engraftment/graft failure. II. To determine the day 100 and 6 month non-relapse mortality (NRM). III. To estimate the cumulative incidence of grade 2-4 and 3-4 acute graft versus (vs.) host disease (aGVHD). IV. To assess the rate of chronic GVHD within the first year post transplantation. V. To assess immune reconstitution and the incidence of infectious episodes. VI. To assess disease response, disease-free survival (DFS) and overall survival (OS) after transplantation. VII. To compare results with a retrospective cohort of patients treated with bone marrow graft on protocol 2009-0266. OUTLINE: Patients receive melphalan intravenously (IV) over 30 minutes on day -6 and fludarabine phosphate IV over 1 hour on days -6 to -3. Patients undergo total-body irradiation (TBI) on day -2 and CD45RA depleted peripheral blood stem cell transplantation on day 0. Patients also receive cyclophosphamide IV over 3 hours on days 3-4. Beginning on day 5, patients receive tacrolimus IV for 2 weeks and orally (PO) for at least 4 months. Beginning on day 7, patients receive filgrastim subcutaneously (SC) daily. Patients with CD20 positive lymphoma may receive rituximab IV on days -13, -6, 1, and 8. After completion of study treatment, patients are followed up periodically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Given IV
Given SC
Given IV
Correlative studies
Given IV
Undergo CD45RA depleted peripheral blood stem cell transplantation
Given IV
Given IV or PO
Undergo TBI
M D Anderson Cancer Center
Houston, Texas, United States
Incidence of treatment failure defined as primary graft failure, grade 3-4 acute graft versus host disease (aGVHD), or non-relapse mortality
Time frame: Up to 100 days
Immune reconstitution
Will be summarized by number of participants.
Time frame: Up to 3 years
Incidence of infectious episodes
Will be summarized by counts of participants .
Time frame: Up to 3 years
Disease free survival (DFS) time
Will be estimated using the method of Kaplan and Meier.
Time frame: Up to 3 years
Overall survival (OS) time
Will be estimated using the method of Kaplan and Meier.
Time frame: Up to 3 years
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