This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening.
PRIMARY OBJECTIVES: I. To determine if haploidentical stem cell transplant using post-transplant cyclophosphamide results in 60% or better disease free survival (DFS) at 12 months at our institution. SECONDARY OBJECTIVES: I. To determine the rate of acute and chronic graft-versus-host disease (GvHD), non-relapse mortality, and relapse. OUTLINE: PREPARATIVE REGIMEN: Patients receive fludarabine phosphate intravenously (IV) once daily (QD) on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2 TRANSPLANT: Patients undergo stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. After completion of study treatment, patients are followed up periodically for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Given IV
Given IV
Given IV
Undergo myeloablative or reduced intensity allogeneic stem cell transplant
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
12 Month Disease Free Survival Probability
The percentage of patients who experience death or disease relapse by one year will be calculated and a corresponding 95% confidence interval will be constructed using the normal approximation for binomial proportions. The survival function will be estimated and plotted using the method of Kaplan and Meier.
Time frame: At 12 months
Rate of Acute GvHD
Kaplan-Meier estimation of the rate of acute GvHD in the study population at one year with a 95% confidence interval.
Time frame: 12 months
Overall Survival
The survival function will be estimated and plotted using the method of Kaplan and Meier.
Time frame: At 12 months
Progression Free Survival
Kaplan-Meier estimation of the percentage of patients who are alive without progressive disease at one year.
Time frame: At 12 months
Relapse-free Mortality
Non-relapse mortality will be defined as time from registration to death due to anything other than relapse of hematological malignancy. Patients who relapse will be treated as a competing risk.
Time frame: At 12 months
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