Hematopoietic/Lymphoid CancerNCT02158767
Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.
A study testing Allogenic T cell-depleted hematopoietic stem cell transplantation in people with Hematopoietic/Lymphoid Cancer, run by Leland Metheny at 1 site in United States.
Trial summary
This clinical trial studies the use of a second infusion of donor hematopoietic cells that have had removal of T cells for the treatment of engraftment failure after a first hematopoietic stem cell transplant. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Hematopoietic/Lymphoid Cancer
- What is being tested?
- Allogenic T cell-depleted hematopoietic stem cell transplantation
- 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 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who received a prior hematopoietic progenitor cell transplantation, including matched sibling and unrelated donor transplants, mismatched sibling and unrelated donor transplants and haploidentical transplants from related donors
- Patients with a presence of secondary engraftment failure defined as decrease in donor chimerism by ≥ 50% (i.e. 40% to 20%) in two measurements done at least 30 days apart
- OR a presence of incomplete graft function manifested by presence of persistent or new cytopenias 60 or more days after transplantation:
- Anemia; hemoglobin less than 8g/dL, or red blood cell transfusion requirements over the preceding 4 weeks
- Neutropenia, with absolute neutrophil count less than 1,000 neutrophils per microliter or requirement of growth factor support over the preceding 4 weeks
- Thrombocytopenia, with platelet counts below 20,000 platelets per microliter or platelet transfusion requirements over the preceding 4 weeks
Who cannot join
- Patients for whom hematopoietic progenitor cells from the original donor are not available
- Presence of reversible causes of engraftment failure or incomplete graft function, including
- Active viral infection
- Medications
- Acute or chronic graft versus host disease (GVHD) that is not controlled to less or equal than stage II with immunosuppressants
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
This clinical trial studies the use of a second infusion of donor hematopoietic cells that have had removal of T cells for the treatment of engraftment failure after a first hematopoietic stem cell transplant.
Hematopoietic cell transplants from donors can be complicated by complete or incomplete failure of recovery of blood counts. This results in frequent needs for transfusions and other methods to maintain blood counts at acceptable levels. One way of improving the blood counts in the recipient is to give a "booster" dose of cells from the donor, but this is associated with increased risk of an immune reaction from the donor cells against the recipient cells. To decrease this risk, it is possible to decrease the amount of T cells, responsible for this type of immune reaction. These cells are removed by a special handling of the graft, which allows to remove the cells directly or indirectly (by selecting other cells to "stay" in the graft").
Read the detailed description
PRIMARY OBJECTIVES:
- To provide patients with suboptimal engraftment after allogeneic stem cell transplantation access to donor - derived, cluster of differentiation (CD34)+ enriched or T-cell depleted peripheral blood stem cells isolated by the CliniMACS System.
OUTLINE:
Patients undergo CD34+ enriched or T-cell depleted peripheral blood stem cell infusion (PBSCT) over 1-3 hours.
After completion of study treatment, patients are followed up for 100 days.
- Conditions
- Hematopoietic/Lymphoid Cancer
- Being tested
- Allogenic T cell-depleted hematopoietic stem cell transplantation
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogenic T cell-depleted hematopoietic stem cell transplantationBiological
Undergo CD34+ enriched T-cell depleted allogeneic peripheral blood stem cell transplant. T-cells will be removed using the experimental CliniMACS(r) Reagent System used in vitro to select and enrich CD34+ cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic/Lymphoid CancerStudies 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
- Leland Metheny
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leland Metheny, Case Comprehensive Cancer Center
- Investigators
- Leland Metheny, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158767
- Sponsor's protocol ID
- CASE16Z13
- Status last verified
- Mar 2025
- First submitted
- 5 Jun 2014
- Last updated
- 12 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access Protocol. Infusion of CD34+ Enriched, T Cell Depleted Hematopoietic Stem Cell Grafts.
- ClinicalTrials.gov ID
- NCT02158767
- Acronym / sponsor ID
- CASE16Z13
- Conditions
- Hematopoietic/Lymphoid Cancer
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Leland MethenyUniversity, hospital or other
- First posted
- 9 Jun 2014 (estimated)
- 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 clinical trial studies the use of a second infusion of donor hematopoietic cells that have had removal of T cells for the treatment of engraftment failure after a first hematopoietic stem cell transplant.
Hematopoietic cell transplants from donors can be complicated by complete or incomplete failure of recovery of blood counts. This results in frequent needs for transfusions and other methods to maintain blood counts at acceptable levels. One way of improving the blood counts in the recipient is to give a "booster" dose of cells from the donor, but this is associated with increased risk of an immune reaction from the donor cells against the recipient cells. To decrease this risk, it is possible to decrease the amount of T cells, responsible for this type of immune reaction. These cells are removed by a special handling of the graft, which allows to remove the cells directly or indirectly (by selecting other cells to "stay" in the graft").
Detailed description
PRIMARY OBJECTIVES:
- To provide patients with suboptimal engraftment after allogeneic stem cell transplantation access to donor - derived, cluster of differentiation (CD34)+ enriched or T-cell depleted peripheral blood stem cells isolated by the CliniMACS System.
OUTLINE:
Patients undergo CD34+ enriched or T-cell depleted peripheral blood stem cell infusion (PBSCT) over 1-3 hours.
After completion of study treatment, patients are followed up for 100 days.
Study design
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who received a prior hematopoietic progenitor cell transplantation, including matched sibling and unrelated donor transplants, mismatched sibling and unrelated donor transplants and haploidentical transplants from related donors
- Patients with a presence of secondary engraftment failure defined as decrease in donor chimerism by ≥ 50% (i.e. 40% to 20%) in two measurements done at least 30 days apart
- OR a presence of incomplete graft function manifested by presence of persistent or new cytopenias 60 or more days after transplantation:
Key exclusion criteria (5 listed)
- Patients for whom hematopoietic progenitor cells from the original donor are not available
- Presence of reversible causes of engraftment failure or incomplete graft function, including
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 |
|---|---|---|
| Allogenic T cell-depleted hematopoietic stem cell transplantationUndergo CD34+ enriched T-cell depleted allogeneic peripheral blood stem cell transplant. T-cells will be removed using the experimental CliniMACS(r) Reagent System used in vitro to select and enrich CD34+ cells | Biological | – |
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 12 Mar 2025.
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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.
Leland Metheny, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allogenic T cell-depleted hematopoietic stem cell transplantation in people with Hematopoietic/Lymphoid Cancer, run by Leland Metheny 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 6 inclusion and 5 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 12 Mar 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 12 Mar 2025.