Sponsors

Lead Sponsor

Memorial Sloan Kettering Cancer Center

Age

0 - 19 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Malignant conditions for which CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as:
•AML in 1st remission - for patients whose AML does not have 'good risk' cytogenetic features (i.e. t 8;21, t15;17, inv 16).
•Secondary AML in 1st remission
•AML in 1st relapse or \> 2nd remission
•ALL/LL in 1st remission clinical or molecular features indicating a high risk for relapse; or ALL \> 2nd remission
•CML failing to respond to or not tolerating Imatinib, dasatinib, or nilotinib in first chronic phase of disease; or CML in accelerated phase or second chronic phase.
•Non-Hodgkins lymphoma with chemoresponsive disease in any of the following categories: a) intermediate or high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.
•Each donor must meet criteria outlined by institutional policies
•Donor must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter.

Exclusion Criteria

•Chronic myelomonocytic leukemia: CMML-1 and CMML-2.
•Other rare lethal disorders of Hematopoiesis and Lymphopoiesis for which a T-cell depleted transplant is indicated (e.g. hemophagocytic lymphohistiocytosis; refractory aplastic anemia or conjugated cytopenias; non-SCID lethal genetic immunodeficiencies such as Wiskott Aldrich Syndrome, CD40 ligand deficiency, ALPS).
•Patients may be of either gender and of any racial or ethnic background.
•Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status \> 70%.
•Patients must have adequate organ function measured by:
•Cardiac: asymptomatic or if symptomatic then LVEF at rest must be \> 50% and must improve with exercise.
•Hepatic: \< 3x ULN ALT and \< 2.0x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
•Renal: serum creatinine \<1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl \> 40 ml/min (measured or calculated/estimated)
•Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglobin)
•Each patient must be willing to participate as a research subject and must sign an informed consent form.
•Female patients who are pregnant or breast-feeding
•Uncontrolled viral, bacterial or fungal infection
•Patient seropositive for HIV-I/II; HTLV -I/II
•Presence of leukemia in the CNS.
•Evidence of active infection (including urinary tract infection, or upper respiratory tract infection), viral hepatitis exposure (on screening), unless only HBS Ab+ and HBV DNA negative, or serologic evidence of exposure or infection with HIV-I/II or HTLV-I/II
•If donors do not meet institutional guidelines, exclusion will be considered.

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