Intentional Rejection of the Donor Graft Using Recipient Leukocyte Infusion(s) Following Nonmyeloablative Allogeneic Stem Cell Transplant
Inclusion Criteria:
1. Patients with chemorefractory non-Hodgkin's or Hodgkin's lymphoma or multiple
myeloma.
Criteria for consideration of enrollment will include:
1. primary refractory or refractory relapsed disease for which autologous HCT is
unlikely to be beneficial;
2. relapse after autologous HCT
3. ineligibility for standard myeloablative or nonmyeloablative allo-HCT because of
either lack of a donor or patient considerations
2. Non Hodgkin's lymphoma, or Hodgkin's lymphoma: primary refractory or refractory
relapse
3. Multiple myeloma; primary refractory or refractory relapse
4. Patients with the above malignancies who have had a previous autologous or allogeneic
bone marrow or stem cell transplant.
5. An estimated disease-free survival of less than one year.
6. Age 18 to age < 75 years
7. ECOG performance status of 0, 1, or 2.
Exclusion Criteria:
1. Patients whose life expectancy is limited by diseases other than their malignancy
2. Patients who have a 5/6 or better matched related donor or a 4/6 or better umbilical
cord blood donor and who are medically eligible for conventional myeloablative or
non-myeloablative transplant will be excluded
3. Cardiac disease: symptomatic congestive heart failure or RVG or echocardiogram
determined LVEF ogf< 30%, active angina pectoris or uncontrolled hypertension
4. Pulmonary disease: severe chronic obstructive lung disease, or symptomatic
restrictive lung disease, or corrected DLCO < 40% of predicted
5. Renal disease: serum creatinine > 3.0 mg/dl.
6. Hepatic disease: serum bilirubin > 3.0 mg/dl or alkaline phosphatase, SGOT or SGPT >
3 x ULN
7. Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other
neuropsychiatric abnormalities believed to preclude transplantation (pervious CNS
malignancy presently in CR is not an exclusion)
8. Uncontrolled infection.
9. Recipient leukocyte infusion (RLI) might involve the infusion of circulating tumor
cells to the patients. To minimize this risk patients who have evidence of
circulating tumor cells by light microscopy and flow cytometry will be excluded
10. Patients with acute leukemia will be excluded because they will likely have much
greater circulating tumor burden, which would increase the risk of infusion of clonal
tumor cells