Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation

Status:

NO_LONGER_AVAILABLE

Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation

Lead Sponsor:

Emory University

Conditions:

Chronic Myeloid Leukemia

Myelodysplastic Syndrome

Eligibility:

All Genders

17-75 years

Brief Summary

Allogeneic hematopoietic stem cell transplantation (HSCT) is an established form of treatment for hematological abnormalities. Poor graft function, occurs when there poor donor engraftment. A second i...

Detailed Description

This is a single-arm, open label, single institution, compassionate study which will enroll patients who are marginally engrafted and transfusion and/or growth factors dependent after allogeneic hemat...

Eligibility Criteria

Inclusion

Donor Inclusion Criteria:
Donors must be eligible and approved for a hematopoietic stem cell graft according to institutional criteria (related donor) or NMDP criteria (volunteer unrelated donor)
Donors must be ≥ 17 years old and ≤ 75 years old
Donors must be agreeable to receive G-CSF for CD34 cell mobilization and undergo apheresis for the second donation of peripheral blood mononuclear cells (PBMC)
Donor must have adequate peripheral venous catheter access for apheresis or must agree to placement of a central catheter
The following laboratory tests/evaluations will be performed for all donors registered in the study. Additional evaluations/studies may also be performed by the site as dictated by the donor's clinical situation or standard practice for monitoring normal donors
History and physical examination
Automated complete blood count (WBC, red blood cells \[RBC\], hematocrit, hemoglobin) with differential and platelet counts
Serum chemistries panel including electrolytes, glucose, blood urea nitrogen (BUN), alanine aminotransferase (ALT), creatinine, bilirubin, alkaline phosphatase, lactate dehydrogenase (LDH) and albumin. Electrolytes to include sodium, potassium, chloride, carbon dioxide, calcium and magnesium.
Infections disease titers by FDA licensed tests for:
Cytomegalovirus (CMV) antibody
Hepatitis panel (Hepatitis B including HBsAg, HBcAb \[immunoglobulin M {IgM} and immunoglobulin G {IgG}\]; hepatitis C antibody)
HIV 1+2 antibodies
Hepatitis C virus (HCV) antibodies
Human T-lymphotropic virus (HTLV) I/II antibodies
Rapid plasmin reagin (RPR)
HIV-1 nucleic acid amplification test (NAT)
HCV NAT
West Nile virus (WNV)
These tests will be obtained, and reported to Emory, within 30 days prior to collection of the CD34+ cell product.
Recipient Inclusion Criteria:
Only patients who are experiencing life-threatening hematological insufficiency, following an allogeneic hematopoietic stem cell transplant will be enrolled into this study
Patient must be age \> 17
Must have ≥ 90% donor cells in the unfractionated peripheral blood based on either XY fluorescence in situ hybridization (FISH) or standard short tandem repeats (STR)
More than 60 days post allogeneic stem cell transplantation and no reversible etiology found after an allogeneic stem cell transplantation
Must meet one of the following criteria:
Platelets \< 20,000/μl, absolute neutrophil count (ANC) \< 500/μl or
Transfusion dependent for at least one cell line and/or
On growth factor support (G-CSF) without adequate response for 30 days
The original HSCT donor must be available, willing, and medically able to undergo G-CSF mobilization and the apheresis procedures
Patients must have non-immune mediated graft dysfunction

Exclusion

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT02258490

Last Update

March 15 2022

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