Benign NeoplasmNCT03626285
Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Treating Participants With Cancer or Other Disorders
A study testing Bone Marrow Transplantation, CliniMACS CD34 Reagent System and Peripheral Blood Stem Cell Transplantation in people with Benign Neoplasm and Bone Marrow Transplantation Recipient, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Benign Neoplasm, Bone Marrow Transplantation Recipient, Hematopoietic Cell Transplantation Recipient
- What is being tested?
- Bone Marrow Transplantation, CliniMACS CD34 Reagent System and Peripheral Blood Stem Cell Transplantation
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
- Available
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Eneida R. Nemecek, 503-494-0829, nemeceke@ohsu.edu
Eneida R. Nemecek
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Benign Neoplasm, Bone Marrow Transplantation Recipient, Hematopoietic Cell Transplantation Recipient, Malignant Neoplasm
- Being tested
- Bone Marrow Transplantation, CliniMACS CD34 Reagent System, Peripheral Blood Stem Cell Transplantation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow TransplantationProcedure or surgery
Also called BMT, Bone Marrow Grafting, Bone marrow transplant, Marrow Transplantation
Undergo BMT
CliniMACS CD34 Reagent SystemDevice
CD34 selection ex vivo
Peripheral Blood Stem Cell TransplantationProcedure or surgery
Also called PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support
Receive CD34-selected peripheral blood stem cells from related or unrelated donors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Eneida Nemecek, OHSU Knight Cancer Institute
- Investigators
- Eneida Nemecek, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626285
- Sponsor's protocol ID
- IRB00010804
- Other IDs
- NCI-2018-00556, NCI-2020-02357, IRB00010804
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2018
- Last updated
- 27 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03626285
- Acronym / sponsor ID
- IRB00010804
- Conditions
- Benign Neoplasm, Bone Marrow Transplantation Recipient, Hematopoietic Cell Transplantation Recipient, Malignant Neoplasm
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- The selected donor must also be:
- Recipients must meet institutional treatment standards based on pre-transplant evaluations including:
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow TransplantationAlso: BMT, Bone Marrow Grafting, Bone marrow transplant, Marrow TransplantationUndergo BMT | Procedure or surgery | – |
| CliniMACS CD34 Reagent SystemCD34 selection ex vivo | Device | – |
| Peripheral Blood Stem Cell TransplantationAlso: PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell SupportReceive CD34-selected peripheral blood stem cells from related or unrelated donors | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eneida Nemecek, MD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Marrow Transplantation, CliniMACS CD34 Reagent System and Peripheral Blood Stem Cell Transplantation in people with Benign Neoplasm and Bone Marrow Transplantation Recipient, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eneida Nemecek, MD (503-494-0829, nemeceke@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.