Graft FailureNCT06569082
CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure
A study testing CD34+ Selected Donor Cell Boost and Blood Stem Cell Infusion in people with Graft Failure and Poor Graft Function, run by NYU Langone Health at 1 site in United States.
Trial summary
The proposed trial is a single arm, non-randomized, single center pilot study utilizing CliniMACS CD34 Reagent System for patients following allogeneic hematopoietic stem cell transplant (HSCT) requiring treatment of graft dysfunction or failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Failure, Poor Graft Function
- What is being tested?
- CD34+ Selected Donor Cell Boost and Blood Stem Cell Infusion
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to Aug 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient of allogeneic transplantation, adult ≥18 years, from any type of donor including matched related, matched unrelated, mismatched related or mismatched unrelated or haploidentical donor transplant.
- Documented evidence of graft dysfunction or failure (a-c):
- Primary graft Failure: Graft failure is defined as failure to achieve neutrophil engraftment by day +28 or lack of donor chimerism > 50% by day 45 not due to the underlying malignancy;
- Poor graft function is defined by at least 2 of the following 3 criteria: Hemoglobin < 8 g/dL, ANC < 0.5x109/L, and platelets < 20x109/L. The cytopenia must be unexplained (such as by disease relapse) and unresponsive to hematopoietic growth factors and must last at least 4 weeks;
- Secondary graft failure is defined as poor graft function associated with donor chimerism < 5% after initial engraftment
- Transplanted donor availability
- Negative pregnancy test within seven (7) days of product infusion for women of childbearing potential.
Who cannot join
- Graft failure due to disease relapse or evidence of disease relapse or progression
- Donor unavailable or unable to collect peripheral HPC by apheresis
- Responsive to conventional measures (such as, hematopoietic growth factor)
- Allergic reaction to murine proteins or iron dextran
- Women of childbearing potential with positive serum HCG
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: CD34+ Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation
The proposed trial is a single arm, non-randomized, single center pilot study utilizing CliniMACS CD34 Reagent System for patients following allogeneic hematopoietic stem cell transplant (HSCT) requiring treatment of graft dysfunction or failure.
Read the detailed description
The primary objective of the study is to estimate the incidence of engraftment with sustained recovery of blood counts, including, absolute neutrophil cell (ANC) and platelet engraftment.
- ANC engraftment is defined as ANC of ≥ 0.5 × 10^9/L for three consecutive laboratory values obtained on different days. Date of ANC recovery is the date of the first of three consecutive laboratory values where the ANC is ≥ 0.5 × 10^9/L.
- Platelet engraftment should reflect no platelet transfusions administered for seven consecutive days. Report the date of the first of three consecutive laboratory values ≥ 20 × 10^9/L obtained on different days.
The secondary objective of the study is to estimate the incidence of Graft-versus-host disease (GvHD) and side effects that can be attributed to the CliniMACS CD34 Selected Cellular Product.
- Conditions
- Graft Failure, Poor Graft Function
- Being tested
- CD34+ Selected Donor Cell Boost, Blood Stem Cell Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD34+ Selected Donor Cell BoostDevice
Also called CliniMACS CD34 Reagent System
The CliniMACS CD34 Reagent System is used to separate CD34 cells from the remaining stem cell product, using a peripheral blood stem cell sample provided by the original donor. These CD34 cells are then infused into the recipient following selection with the intent to restore function of the blood forming cells.
Blood Stem Cell InfusionProcedure or surgery
The selected CD34 cells separated by the CliniMACS CD34 Reagent System are infused into the recipient.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Poor Graft Function or Failure Following Allogeneic HSCT | Experimental | The recipient will undergo evaluations, then undergo a single infusion of CD34 selected HSCT from the original donor.
No additional GvHD prophylaxis will be administered. Patients who develop GvHD will receive the standard of care based on the discretion of the treating physician .
Patients will receive supportive care per institutional standards and at the discretion of the treating physician. Receives: Device: CD34+ Selected Donor Cell Boost; Procedure: Blood Stem Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Absolute Neutrophil Cell (ANC) Engraftment
ANC engraftment is defined as ANC of ≥ 0.5 × 10^9/L for three consecutive laboratory values obtained on different days.
Measured: Day 100 Post-Procedure
Number of Participants with Platelet Engraftment
Platelet engraftment is defined as no platelet transfusions administered for seven consecutive days.
Measured: Day 100 Post-Procedure
Secondary outcomes (2)
Number of Participants with Grade II-IV Acute GVHD
The diagnosis of acute GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician.
Measured: Day 100 Post-Procedure
Number of Participants with Moderate to Severe Chronic GVHD
The diagnosis of chronic GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician.
Measured: Day 365 Post-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start31 Oct 2024
- Primary completionAug 2034 (estimated)
- Study completionAug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft FailureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingmei Hsu, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569082
- Sponsor's protocol ID
- 23-00885
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification, will be shared upon reasonable request provided the investigator whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose executes a data use agreement with NYU Langone Health. Requests may be directed to: Jingmei.hsu@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD34+ Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06569082
- Acronym / sponsor ID
- 23-00885
- Conditions
- Graft Failure, Poor Graft Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- Aug 2034 (estimated)
- Study completion
- Aug 2035 (estimated)
- First posted
- 23 Aug 2024 (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.
The proposed trial is a single arm, non-randomized, single center pilot study utilizing CliniMACS CD34 Reagent System for patients following allogeneic hematopoietic stem cell transplant (HSCT) requiring treatment of graft dysfunction or failure.
Detailed description
The primary objective of the study is to estimate the incidence of engraftment with sustained recovery of blood counts, including, absolute neutrophil cell (ANC) and platelet engraftment.
- ANC engraftment is defined as ANC of ≥ 0.5 × 10^9/L for three consecutive laboratory values obtained on different days. Date of ANC recovery is the date of the first of three consecutive laboratory values where the ANC is ≥ 0.5 × 10^9/L.
- Platelet engraftment should reflect no platelet transfusions administered for seven consecutive days. Report the date of the first of three consecutive laboratory values ≥ 20 × 10^9/L obtained on different days.
The secondary objective of the study is to estimate the incidence of Graft-versus-host disease (GvHD) and side effects that can be attributed to the CliniMACS CD34 Selected Cellular Product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with Poor Graft Function or Failure Following Allogeneic HSCT | Experimental | Device: CD34+ Selected Donor Cell Boost, Procedure: Blood Stem Cell InfusionThe recipient will undergo evaluations, then undergo a single infusion of CD34 selected HSCT from the original donor. No additional GvHD prophylaxis will be administered. Patients who develop GvHD will receive the standard of care based on the discretion of the treating physician . Patients will receive supportive care per institutional standards and at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Recipient of allogeneic transplantation, adult ≥18 years, from any type of donor including matched related, matched unrelated, mismatched related or mismatched unrelated or haploidentical donor transplant.
- Documented evidence of graft dysfunction or failure (a-c):
- Transplanted donor availability
- Negative pregnancy test within seven (7) days of product infusion for women of childbearing potential.
Key exclusion criteria (5 listed)
- Graft failure due to disease relapse or evidence of disease relapse or progression
- Donor unavailable or unable to collect peripheral HPC by apheresis
- Responsive to conventional measures (such as, hematopoietic growth factor)
- Allergic reaction to murine proteins or iron dextran
- Women of childbearing potential with positive serum HCG
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 |
|---|---|---|
| CD34+ Selected Donor Cell BoostAlso: CliniMACS CD34 Reagent SystemThe CliniMACS CD34 Reagent System is used to separate CD34 cells from the remaining stem cell product, using a peripheral blood stem cell sample provided by the original donor. These CD34 cells are then infused into the recipient following selection with the intent to restore function of the blood forming cells. | Device | Individuals with Poor Graft Function or Failure Following Allogeneic HSCT |
| Blood Stem Cell InfusionThe selected CD34 cells separated by the CliniMACS CD34 Reagent System are infused into the recipient. | Procedure or surgery | Individuals with Poor Graft Function or Failure Following Allogeneic HSCT |
Primary outcome
Number of Participants with Absolute Neutrophil Cell (ANC) Engraftment
Time frame: Day 100 Post-Procedure
ANC engraftment is defined as ANC of ≥ 0.5 × 10^9/L for three consecutive laboratory values obtained on different days.
Number of Participants with Platelet Engraftment
Time frame: Day 100 Post-Procedure
Platelet engraftment is defined as no platelet transfusions administered for seven consecutive days.
2 secondary outcomes
Number of Participants with Grade II-IV Acute GVHD
Time frame: Day 100 Post-Procedure
Number of Participants with Moderate to Severe Chronic GVHD
Time frame: Day 365 Post-Procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification, will be shared upon reasonable request provided the investigator whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose executes a data use agreement with NYU Langone Health. Requests may be directed to: Jingmei.hsu@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Jingmei Hsu principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD34+ Selected Donor Cell Boost and Blood Stem Cell Infusion in people with Graft Failure and Poor Graft Function, run by NYU Langone Health 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 7 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: looking for participants now, as of the sponsor's last update on 17 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiselle Mangalindan (646-501-2973, KiselleAnne.Mangalindan@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Absolute Neutrophil Cell (ANC) Engraftment (time frame: Day 100 Post-Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 17 Aug 2026.