Table 2 Criteria for recipient (patient) enrollment
From: Cellular immunotherapy for refractory hematological malignancies
| Recipient eligibility criteria | |
|---|---|
| Inclusion Criteria | Age ≥ 18 |
| Histologic confirmation of the following leukemias/lymphomas: | |
| • Mantle cell lymphoma with Ki-67>30% | |
| • Diffuse Large Cell Lymphoma | |
| • Burkitts Lymphoma | |
| • Systemic T Cell Lymphomas | |
| • Acute Myeloid Leukemia | |
| • Acute Lymphoblastic Leukemia | |
| Recurrence or progression of disease after at least 1 prior standard treatment | |
| Progression of disease within 6 months of last treatment | |
| No available curative treatment option | |
| ≥ 4-weeks since prior chemotherapy or radiation (Exception: Hydroxyurea may be utilized up to 48 hours prior to treatment) | |
| Life expectancy of 2 months at treatment initiation | |
| ≥ 6 months post autologous stem cell transplant | |
| DLCO ≥ 40% with no symptomatic pulmonary disease. | |
| LVEF ≥ 40% by MUGA or echocardiogram. | |
| Creatinine ≤ 2.0 mg/dl, Total bilirubin <1.5x the upper limit of normal (ULN), AST < 3x ULN | |
| Non-pregnant and willing to use appropriate birth control during study period | |
| Exclusion criteria | Previous allogeneic stem cell transplant |
| Previous purine analog (fludarabine, pentostatin, 2-CDA) or alemtuzumab within 1 year of entering the study | |
| CML, CLL, multiple myeloma, and indolent lymphoma (follicular lymphoma, marginal zone lymphoma) | |
| HLA antibodies to donor HLA type | |
| HIV-1 or 2 positive | |
| Oxygen dependant COPD | |
| Failure to demonstrate adequate compliance with medical therapy and follow-up | |
| Significant medical or psychiatric illness that would impair the ability to participate in protocol therapy | |
| Active systemic infection |