Graft Failure, Poor Graft Function
Conditions
Brief 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.
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.
Interventions
DEVICECD34+ Selected Donor Cell Boost
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.
PROCEDUREBlood Stem Cell Infusion
The selected CD34 cells separated by the CliniMACS CD34 Reagent System are infused into the recipient.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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): 1. 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; 2. 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; 3. 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Absolute Neutrophil Cell (ANC) Engraftment | 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 | Day 100 Post-Procedure | Platelet engraftment is defined as no platelet transfusions administered for seven consecutive days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Grade II-IV Acute GVHD | Day 100 Post-Procedure | The diagnosis of acute GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician. |
| Number of Participants with Moderate to Severe Chronic GVHD | Day 365 Post-Procedure | The diagnosis of chronic GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician. |
Countries
United States
Contacts
CONTACTKiselle Mangalindan
CONTACTKelsey Stocker
PRINCIPAL_INVESTIGATORJingmei Hsu
NYU Langone Health
Outcome results
None listed