Sponsors

Lead Sponsor

Northside Hospital, Inc.

Collaborators

Blood and Marrow Transplant Group of Georgia

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•No available matched related or unrelated donor, OR a matched related or unrelated donor will not be available in time frame necessary to perform potentially curative transplant
•Availability of 3/6 - 5/6 matched (HLA-A, B, DR) related donor (donor must have negative HLA cross-match in host vs. graft direction)
•Karnofsky status ≥70%
•One of the following high-risk malignancies:
•1. Chronic Myelogenous Leukemia: Chronic myelogenous leukemia in chronic phase, resistant or intolerant to available tyrosine kinase inhibitors; Chronic myelogenous leukemia in accelerated phase; Chronic myelogenous leukemia with blast crisis that has entered into a second chronic phase following induction chemotherapy
•2. Acute Myelogenous Leukemia in first or greater remission
•3. Myelodysplastic Syndrome at least one of the following: treatment-related; monosmy 7, complex cytogenetics or other high risk karyotype; IPSS score of 1.0 or greater; neutropenia or cytopenia requiring transfusion not responding to therapy; peripheral or BM blast count of \<10%; CMML
•4. Acute lymphocytic leukemia/lymphoblastic lymphoma: 2nd or subsequent complete remission; first complete remission; marrow blasts \<5%, but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH
•5. Chronic Lymphocytic Leukemia/Prolymphocytic Leukemia: previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy including purine analogs
•6. Hodgkin's or Non-Hodgkin's Lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse): previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation
•7. Myeloproliferative diseases (myelofibrosis, CMML)
•8. Multiple Myeloma with relapse after a prior autologous transplant or eligible for allogeneic HSCT based on other risk factors

Exclusion Criteria

•not be excluded on basis of sex, racial, or ethnic backgrounds
•poor cardiac function: left ventricular ejection fraction \<40%
•poor pulmonary function: FEV1 and FVC \<50% predicted
•poor liver function: bilirubin \>2 mg/dl (not due to hemolysis, Gilbert's or primary malignancy)
•poor renal function: Creatinine \>2.0mg/dl or creatinine clearance (calculated creatinine clearance is permitted) \< 40 mL/min based on Traditional Cockcroft-Gault formula: 140 - age (yrs) x Smaller of Actual Weight vs. Ideal Body Weight (kg) / 72 x Serum creatinine (mg/dl)
•HIV-positive
•prior allogeneic transplant
•women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
•any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up

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Sponsors

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