Expanded Access Protocol Using CD3+/CD19+ Depleted PBSC
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Blood Cancer, Infectious Disease, HIV / AIDS, Gastrointestinal, Hematology, Hematology, Diabetes, Leukemia |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Hematology, Immunology / Infectious Diseases, Oncology, Other |
| Healthy: | No |
| Age Range: | Any - 30 |
| Updated: | 3/14/2019 |
| Start Date: | December 2013 |
| End Date: | January 2020 |
| Contact: | Margaret Tartaglione, RN |
| Email: | tartaglione@email.chop.edu |
| Phone: | 215-590-4029 |
Expanded Access Protocol Using CD3+/CD19+ Depleted Unrelated Donor or Partially Matched Related Donor Peripheral Stem Cells
The goal of this protocol is to expand access for patients who lack a fully HLA (Human
leukocyte antigen) matched sibling donor and who are candidates for allogeneic hematopoietic
stem cell transplant (HSCT). These patients have a serious or immediately life-threatening
disease for which HSCT is indicated. These patients are not eligible for other Children's
Hospital of Philadelphia IRB approved protocols that utilize CliniMACs technology for T
depletion.
leukocyte antigen) matched sibling donor and who are candidates for allogeneic hematopoietic
stem cell transplant (HSCT). These patients have a serious or immediately life-threatening
disease for which HSCT is indicated. These patients are not eligible for other Children's
Hospital of Philadelphia IRB approved protocols that utilize CliniMACs technology for T
depletion.
Only 25-30% of patients who may benefit from HSCT have a matched related donor. There is a
higher rate of complications using cells from an unrelated or partially matched related
donor. T cells within the donor cells may cause a complication called graft vs. host disease
(GVHD). The goal of this study is to use the CliniMACs device to remove the T cells that
cause GVHD, called T cell depletion.
higher rate of complications using cells from an unrelated or partially matched related
donor. T cells within the donor cells may cause a complication called graft vs. host disease
(GVHD). The goal of this study is to use the CliniMACs device to remove the T cells that
cause GVHD, called T cell depletion.
Inclusion Criteria:
1. Patients who lack a fully HLA matched sibling and who are candidates for allogeneic
hematopoietic stem cell transplant (HSCT) but do not meet criteria for current open
institutional protocols using ClinMACs device for CD3+/CD19+ depletion.
2. Patients with the following transplantable diseases:
Non-malignant diseases:
Metabolic storage diseases correctable by HSCT
Bone marrow failure syndromes
Immunodeficiencies/immune dysregulation syndromes
Malignant diseases:
Acute leukemias
Chronic leukemias
Lymphomas
Myelodyplastic syndrome
3. Organ function criteria:
Lansky or Karnofsky performance ≥60
Serum creatinine ≤3xupper limit of normal for age
Hepatic: Transaminases ≤10xnormal
Cardiac shortening fraction ≥27%
Bilirubin <2.5x normal (unless elevation due to Gilberts disease)
4. No active untreated infection
5. Signed informed consent
6. No fully HLA matched sibling donor available
7. Females of childbearing potential must have negative pregnancy test
Exclusion Criteria:
1. Uncontrolled bacterial, viral or fungal infections
2. Fully HLA matched sibling donor
3. Donor unable to donate peripheral stem cells
4. Pregnant Females
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Principal Investigator: Nancy J Bunin, MD
Phone: 215-590-4029
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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