Phase I/II Trial for Patients With Advanced Hematologic Malignancies Undergoing Myeloablative Allogeneic HCT With a T Cell Depleted Graft With Simultaneous Infusion of Conventional T Cells and Regulatory T Cells

Recipient

Inclusion Criteria:

- Patients with the following diseases that are histopathologically confirmed are
eligible

- Acute leukemia, primary refractory or beyond CR1

- Chronic myelogenous leukemia (accelerated, blast or second chronic phase)

- Myelodysplastic syndromes

- Non-Hodgkin lymphoma with poor risk features not suitable for autologous HCT

- Age <= 60 yo

- Cardiac ejection fraction >= 45%

- Lung diffusion capacity >= 50%

- Calculated creatinine clearance >= 50 cc/min

- SGPT and SGOT <= 2.5 x ULN, unless elevated secondary to disease. Total bilirubin
<= 2 x ULN (patients with Gilbert's syndrome may be included at the discretion of the
PI or where hemolysis has been excluded

- Availability of a 6/6 HLA matched sibling defined by Class I (HLA -A and B) serologic
typing (or higher resolution) and Class II (HLA-DRB1) molecular typing.

- Karnofsky performance status >=70%

- No prior myeloablative therapy or hematopoietic cell transplantation

Recipient Exclusion Criteria

- Seropositive for any of the following: HIV ab, hepatitis B sAg , hep C ab

- Uncontrolled bacterial, viral or fungal infection defined as currently taking
antimicrobial therapy and progression of clinical symptoms.

- Uncontrolled CNS disease involvement

- The recipient is pregnant or a lactating female

- Psychosocial circumstances that preclude the patient being able to go through
transplant or participate responsibly in follow up care.

Donor Inclusion Criteria

- Age <= 75 years

- Karnofsky performance status of >=70%

- Medical history and PE confirm good health status as defined by institutional
standards

- Seronegative for HIV Ag, HIV 1 and HIV 2 ab, HTLV 1 and HTLV 2 ab hepatitis B sAg or
PCR+ or hepatitis C ab or PCR+ , negative for the Syphilis treponemal screen and
negative for HIV 1 and hepatitis C by NAT (nucleic acid testing) within 30 days of
apheresis collection

- Must be 6/6 matched sibling donor as determined by HLA typing

- Female donors of child-bearing potential must have a negative serum or urine beta-HCG
test within three weeks of mobilization

- Capable of undergoing leukapheresis, have adequate venous access, and be willing to
undergo insertion of a central catheter should leukapheresis via peripheral vein be
inadequate

- The donor or legal guardian greater than 18 years of age, capable of signing an
IRB-approved consent form.

Donor Exclusion Criteria

- Evidence of active infection or viral hepatitis

- HIV positive

- Lactating female