Phase I/II Study of Treg/Tcon Addback to CD34 Selected Partially Matched Related Donor Stem Cells With Myeloablative Conditioning for High Risk Hematologic Malignancies
1. Age 0-70 years
2. Karnofsky or Lansky Performance status >70%
3. High risk hematologic malignancy (see section 5.1)
4. No suitable HLA-identical sibling donor
5. No identified 8/8 allele matched unrelated donor, or unable to wait sufficient time
to procure a 8/8 allele matched unrelated donor
6. Available HLA 3-5/6 matched genotypically haploidentical partially matched related
7. Female patients must be surgically sterile, postmenopausal (minimum 1 year without
menses), or agree to use approved form of contraception from the time of signing the
informed consent form through Day +100. Male patients must also agree to use an
approved form of birth control for either themselves or their partner, as
appropriate, from the time of signing the informed consent form through Day +100.
8. Able to provide informed consent and have signed an approved consent form that
conforms to federal and institutional guidelines.
1. Available HLA identical matched sibling donor (unless having failed a prior
allogeneic transplant from an HLA identical matched sibling)
2. Recipient HLA antibodies against donor HLA
3. Any of the following organ dysfunctions:
1. Cardiac- left ventricular ejection fraction <40%, symptomatic coronary artery
disease, or uncontrolled arrhythmias
2. Pulmonary- FEV1 or DLco<50% or need for use of supplemental oxygen
3. Renal- calculated or measured GFR <30 ml/min, dialysis requirement, or prior
4. Hepatic- bilirubin > 2 X ULN, ALT> 2.5 X ULN, cirrhosis
4. Patients with active or uncontrolled bacterial, viral, or fungal infections requiring
5. Patients who have tested positive for HIV.
6. Pregnant women, nursing mothers or women of child-bearing potential who are unwilling
to use medically accepted methods of contraception.