Hematologic Disease and Disorders, Hematopoietic Cell Transplant
Conditions
Brief summary
To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process
Interventions
DRUGTacrolimus
Begins Day -1 and continues to Day +90 or Day +180 after transplant
DRUGCyclophosphamide
Given Days +3 and +4 after transplant
Given Day 0 to Day +35 after transplant
Sponsors
Northside Hospital, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Availability of a 5/10-8/10 mismatched (HLA-A, B, DR) haploidentical related donor with a negative HLA cross-match in the host vs. graft direction and willing to provide peripheral blood stem cells * Karnofsky status \>/= 70% * Hematologic malignancy requiring allogeneic transplantation * First allogeneic transplant only. Prior autologous transplant is allowed.
Exclusion criteria
* Poor cardiac function: LVEF \<40% * Poor pulmonary function: FEV1 and FVC \<50% predicted * Poor liver function: bilirubin \>/= 3mg/dL (not due to hemolysis, Gilbert's or primary malignancy) * Poor renal function: Creatinine \>/= 2mg/dL or creatinine clearance (calculated or measured creatinine clearance is permitted) \<40mL/min based on Traditional Cockcroft-Gault formula * Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception * Patients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy in preventing CRS post transplant | 30 days | Evaluate the incidence of CRS during the first 5 days following stem cell transplant by recording signs and symptoms based on CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of CRS after stem cell transplant | 30 days | Record incidence of CRS by grading signs and symptoms using the CTCAE v5.0, the day of onset of CRS, the duration of CRS, and admissions to the hospital for these events |
| Safety of administering early immunosuppression | 6 months | Record incidence of acute graft-versus-host disease at 6 months by using the NIH Grading Consensus system |
Countries
United States
Contacts
Primary ContactMelh Solh, MD
Backup ContactCaitlin Guzowski, MBA, MHA, CCRC
Outcome results
None listed