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New treatment option for Graft Failure
Official title CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure
ClinicalTrials.gov ID: NCT06569082
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Recipient of allogeneic transplantation, adult ≥18 years, from any type of donor including matched related, matched unrelated, mismatched related or...
- 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...
- 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...
- Secondary graft failure is defined as poor graft function associated with donor chimerism \< 5% after initial engraftment
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.