This phase II trial studies how well fludarabine phosphate, cyclophosphamide, total body irradiation, and donor stem cell transplant work in treating patients with blood cancer. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient?s immune cells and help destroy any remaining cancer cells.
PRIMARY OBJECTIVES: I. To evaluate the rate of relapse, defined as recurrence of underlying disease or progression of underlying disease, at 1 year in patients who receive haploidentical peripheral blood stem cells (PBSCs) after reduced intensity conditioning and post-transplant cyclophosphamide and tocilizumab (or tocilizumab alternative). SECONDARY OBJECTIVES: I. To evaluate safety including development of acute graft versus host disease (GVHD) and death at 100 days post-transplant, as well as other treatment related toxicities including chronic GVHD, engraftment rate, non-relapse mortality, progression free survival (PFS) at one year, and overall survival (OS) at one year, as compared with historical controls. TERTIARY OBJECTIVES: I. Correlative studies will include chimerism analysis by molecular analysis and evaluation of immune reconstitution by cytomegalovirus (CMV) dextramer analysis using flow cytometry. OUTLINE: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo total body irradiation (TBI) on days -1 and peripheral blood stem cell transplantation (PBSCT) on day 0. After completion of study treatment, patients are followed up at 30 and 100 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Given IV
Given IV
Correlative studies
Undergo PBSCT
Undergo TBI
Roswell Park Cancer Institute
Buffalo, New York, United States
Relapse Rate
The number of participants that relapse within 1 year.
Time frame: At 1 year
ANC Engraftment Rate, the Percentage of Participants That Had a Successful Engraftment
Absolute Neutrophil Count Engraftment rate was defined as the number of participants that received an engraftment within 1 year post-transplant and ANC \> 0.5x10\^9/L for three consecutive days, out of the total number of participants. The rate was computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
Time frame: At 1 year post-transplant
Platelet Engraftment Rate, the Percentage of Participants That Had a Successful Engraftment
Platelet Engraftment rate was defined as the number of participants that received an engraftment within 1 year post-transplant and the platelets \>= 20 x 10\^9/L after 7 consecutive days with no platelet transfusions, out of the total number of participants. The rate was computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
Time frame: At 1 year post-transplant
Proportion of Participants With Acute Graft Versus Host Disease (GVHD)
Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
Time frame: At 100 days post-transplant
Proportion of Participants With Chronic Graft Versus Host Disease (GVHD)
Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
Time frame: At 1 year post-transplant
Overall Survival
Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. Will be obtained using the product-limit based Kaplan-Meier method.
Time frame: up to 5 years and 8 months
Progression Free Survival
Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. Will be obtained using the product-limit based Kaplan-Meier method.
Time frame: up to 5 years and 8 months
Transplant Related Mortality
Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
Time frame: At 1 year post-transplant
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