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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