Status:
TERMINATED
Intentional Rejection of the Donor Graft Using Recipient Leukocyte Infusion(s) Following Nonmyeloablative Allogeneic Stem Cell Transplant
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Non Hodgkin's Lymphoma
Hodgkin Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The proposed study is based on our observation of paradoxical tumor regression after rejection of the donor graft in conjunction with the results of our murine experiments. We hypothesize that clinica...
Eligibility Criteria
Inclusion
- Patients with chemorefractory non-Hodgkin's or Hodgkin's lymphoma or multiple myeloma.
- Criteria for consideration of enrollment will include:
- primary refractory or refractory relapsed disease for which autologous HCT is unlikely to be beneficial;
- relapse after autologous HCT
- ineligibility for standard myeloablative or nonmyeloablative allo-HCT because of either lack of a donor or patient considerations
- Non Hodgkin's lymphoma, or Hodgkin's lymphoma: primary refractory or refractory relapse
- Multiple myeloma; primary refractory or refractory relapse
- Patients with the above malignancies who have had a previous autologous or allogeneic bone marrow or stem cell transplant.
- An estimated disease-free survival of less than one year.
- Age 18 to age \< 75 years
- ECOG performance status of 0, 1, or 2.
Exclusion
- Patients whose life expectancy is limited by diseases other than their malignancy
- 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
- Cardiac disease: symptomatic congestive heart failure or RVG or echocardiogram determined LVEF ogf\< 30%, active angina pectoris or uncontrolled hypertension
- Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO \< 40% of predicted
- Renal disease: serum creatinine \> 3.0 mg/dl.
- Hepatic disease: serum bilirubin \> 3.0 mg/dl or alkaline phosphatase, SGOT or SGPT \> 3 x ULN
- 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)
- Uncontrolled infection.
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00909948
Start Date
November 1 2008
End Date
August 1 2012
Last Update
March 29 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114