Status:
TERMINATED
T-cell Depleted Alternative Donor Transplantation
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE2
Brief Summary
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 ste...
Detailed Description
A major issue in alternative donor (mismatched related and unrelated donor transplantation is the development of graft-versus-host disease (GVHD). Several clinical trials have shown that the use of T-...
Eligibility Criteria
Inclusion
- 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:
- Able to receive G-CSF and undergo apheresis either through placement of catheters in antecubital veins or a temporary central venous catheter,
- Healthy,
- Willing,
- 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 6.1.3.2 or an unmanipulated PBSC product.
- 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.
Exclusion
- 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 \<60 ml/min/1.72 m2; can be lower if a reduced intensity conditioning regimen is used.
- Pulmonary diffusion capacity (adjusted for Hgb), FEV1, or FVC \<60% of predicted or O2 sat \< 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. The bilirubin criteria for sickle cell disease patients is direct bilirubin \>2x upper limit of normal.
- Performance score (Lansky/Karnofsky) \< 50
- Any condition that compromises compliance with the procedures of this protocol, as judged by the principal investigator.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00968864
Start Date
August 1 2009
End Date
November 1 2016
Last Update
April 22 2022
Active Locations (1)
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1
Levine Children's Hospital, Carolinas Medical Center
Charlotte, North Carolina, United States, 28204