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