Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Treating Participants With Cancer or Other Disorders



Status:Recruiting
Healthy:No
Age Range:Any - 70
Updated:8/15/2018
Start Date:August 6, 2017
End Date:December 31, 2020
Contact:Eneida Nemecek, MD
Email:nemeceke@ohsu.edu
Phone:503-494-0829

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Institutional Protocol of Bone Marrow Transplantation Using CD34-Selected Peripheral Blood Stem Cells From Related Haploidentical or Unrelated Donors for Treatment of Malignant and Nonmalignant Disorders

This expanded access protocol studies bone marrow transplantation using CD34-selected stem
cells from related or unrelated donors in treating participants with cancer or other
disorders. Stem cells collected from the donor will be processed using a new device called
CliniMACS CD34 Reagent System which marks the blood cells collected from the donor with a
special protein called "antibody" that tags only the donor stem cells, sorting out other
cells of the blood and immune system. This is done to remove, at least partially, some of the
T cells. T cells are the cells in the blood that work as scavengers of the immune system
deciding what belongs and what does not. These cells can sometimes cause rejection of the
donor graft or a condition called graft-versus host disease (GVHD), where the donor cells can
attack the body of the recipient. A bone marrow transplantation using CD34-selected stem
cells may reduce the risk of these unwanted side effects of transplant as much as possible.

PRIMARY OBJECTIVES:

I. To provide a source of CD34-selected stem cells for patients with malignant and
nonmalignant disorders undergoing bone marrow transplantation from haploidentical (human
leukocyte antigen [HLA]-mismatched) related donors or HLA-compatible unrelated donors

SECONDARY OBJECTIVES:

I. Monitoring the safety of the CD34-selected stem cells for the recipient, as measured by
adverse events related to stem cell infusion, incidence of engraftment of neutrophils and
platelets, incidence of acute and chronic GVHD, and one year overall survival, disease-free
survival, and primary disease recurrence.

OUTLINE:

Donor stem cells undergo CD34 selection ex vivo using the CliniMACS CD34 Reagent System using
standard operating procedures (SOPs) from the manufacturer. Recipients undergo standard of
care preparative regimen, bone marrow transplantation with CD34-selected peripheral blood
stem cells via infusion over 1 to 2 hours on day 0, and then receive standard of care GVHD
prophylaxis.

After completion of study treatment, recipients are followed up at least once weekly while
inpatient until transplant day 100, every 1-3 months for the first year and yearly
thereafter.

Inclusion Criteria:

- Patients with malignant or nonmalignant diseases that can benefit from alternative
stem cell transplantation according to institutional standard practice guidelines

- Patients lacking a healthy human leukocyte antigen (HLA)-identical related donor and
having one of the following alternative donor sources:

- HLA-haploidentical related (HLA antigen genotypic match >= 4/8 and <= 7/8) or

- Unrelated donor that is HLA matched at >= 7/8 HLA antigen loci

- The selected donor must also be:

- Able to receive granulocyte colony-stimulating factor (G-CSF, filgrastim) and
undergo apheresis either through placement of peripheral or temporary central
venous catheter, based on institutional guidelines for peripheral blood stem cell
collection

- Meet all institutional standard criteria for clearance for peripheral stem cell
collection

- Recipients must meet institutional treatment standards based on pre-transplant
evaluations including:

- Adequate major organ functions

- Free of major systemic infections

- Not pregnant, if female of childbearing age (post-pubertal)

- Recipient (if >= 18 years) or their parent/legal guardian (if < 18 years) must be able
to sign the informed consent form for the treatment plan; assent will be obtained from
recipients 7-17 years of age, in accordance to our institutional guidelines

Exclusion Criteria:

- Patients not meeting clearance criteria for bone marrow transplantation (BMT) based on
standard institutional guidelines

- Presence of anti-HLA antibodies against donor antigens in a recipient or anti-HLA
antibodies against recipient antigens in a donor

- Known allergy to murine (mouse) protein or iron-dextran
We found this trial at
1
site
3181 S.W. Sam Jackson Park Road
Portland, Oregon 97239
503 494-7999
Principal Investigator: Eneida R. Nemecek
Phone: 503-494-0829
OHSU Knight Cancer Institute OHSU Knight Cancer Institute is known worldwide for our contributions to...
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