- Ages Eligible for Study
- Up to 30 years
- Genders Eligible for Study
T cell depleted, Matched unrelated donors, and Haplocompatible donors
- Andrew Gilman
- Age < 30 years
- Patient must have a malignant or non-malignant disease that can benefit from
alternative stem cell transplantation. Examples include acute and chronic leukemias,
myelodysplastic syndrome, lymphoma, severe acquired and congenital cytopenias, white
and red blood cell abnormalities, and immunodeficiencies.
- Patients with acute lymphoblastic leukemia must be in morphological remission (< 5%
blasts) at the time of transplant. Patients with acute non-lymphocytic leukemia will
preferably be in morphologic remission but may be enrolled when aplastic after
chemotherapy or with < 20% blasts. Patients with lymphoma must be in complete or
close to complete remission (if residual adenopathy, PET scan must be negative or
only have slight uptake, eg. SUV < 2).
- Patients must lack a healthy HLA-identical related donor of at least one year of age.
- Patient must have a mismatched related or an unrelated donor who is:
1. Able to receive G-CSF and undergo apheresis either through placement of
catheters in antecubital veins or a temporary central venous catheter,
4. d) For recipients of an unrelated donor transplant, recipient eligibility will
be restricted as follows if in the judgment of the recipients' transplant
physician, the recipient cannot receive a transplant with combined positive and
negative fractions as described in Section 220.127.116.11 or an unmanipulated PBSC
5. Meets eligibility criteria for donors.
- If only one mismatched related relative is available, an acceptable unrelated donor
must be identified as a backup.
- Patient or authorized guardian must sign informed consent for this study.
- Patient with an anticipated life expectancy of < 1 month
- Active infectious hepatitis or CMV infection
- HIV or HTLV-I/II infection
- Serious infection (bacterial, fungal, viral) within the last 4 weeks
- Cardiac ejection fraction < 45%; can be lower if patient is not in clinical cardiac
failure and a reduced intensity conditioning regimen is used.
- Creatinine clearance < 94% if unable to perform PFTs; can be lower if a reduced intensity conditioning
regimen is used.
- Serum ALT > 3 x upper limit of normal (can be up to 5 x upper limit of normal if a
reduced intensity conditioning regimen is used) or bilirubin > 2.
- Performance score (Lanksy/Karnofsky) < 50
- Any condition that compromises compliance with the procedures of this protocol, as
judged by the principal investigator.
The primary purpose is to determine the ability of CD34+ selection and T cell depletion using the CliniMACS® device to prevent severe acute graft-versus-host disease (GVHD) in patients receiving a stem cell transplant from an alternative (unrelated and mismatched related) donor. The secondary objectives include evaluation of engraftment, immune recovery, and post-transplant infections. Patients requiring stem cell transplants for either malignant (cancerous) or non-malignant disease will be included in the study. The recipients will be grouped into one of two groups based on whether the donor is mismatched related (Cohort A) or unrelated (Cohort B). The patient will receive a conditioning regimen including chemotherapy drugs and/or total body irradiation based on the disease for which the transplant is performed.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968864