At a glance
ClinicalIndex Comparison Record- ✓Must have an available 8/8 HLA-matched (HLA-A, -B, -C, -DRB1) related or unrelated donor for allogeneic hematopoietic stem cell transplant.
- ✓Diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplasia (MDS), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), myeloproliferative neoplasms, Hodgkin lymphoma, or non-Hodgkin lymphoma requiring allogeneic HSCT.
- ✓For acute leukemia (AML or ALL): complete remission with <5% marrow blasts, no morphologic evidence of leukemia, no peripheral blasts, marrow >20% cellular, and peripheral absolute neutrophil count >1000/uL.
- ✓For MDS and CML: <5% marrow blasts.
- ✕Active infection not controlled with appropriate antimicrobial therapy.
- ✕History of HIV, hepatitis B, or active hepatitis C infection.
- ✕Prior use of anti-thymocyte globulin, alemtuzumab, bortezomib, or post-transplant cyclophosphamide as part of GVHD prophylaxis.
- ✕Sorror's comorbidity score >4.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression
In Brief
A Phase 2 clinical trial evaluating Pacritinib, Sirolimus, and 2 other interventions for Graft Vs Host Disease and GVHD. Completed, enrolled 40 participants across 2 sites.
Detailed Summary
The purpose of this study is to examine a new approach to preventing a serious problem after transplant called graft vs. host disease (abbreviated as GVHD). This is a 3 arm sequential phase I/II, study of Pacritinib with Sirolimus and Tacrolimus (PAC/SIR/TAC) for the prevention of acute GVHD after matched related and unrelated allogeneic hematopoietic cell transplantation (alloHCT).
Study Details
Timeline
Interventions
Pacritinib Dose and Schedule: 200 mg twice a day (BID) orally from day 0 until day +100. PAC will be tapered to 50% of the total dose at day +70, then 25% of total dose at day +84, then stop at day +100 (+/- 7 days).
Sirolimus (SIR) will be administered and dosed according to Moffitt Cancer Center, Department of Blood and Marrow Transplantation standard practice. Attending physician discretion is permitted with regard to timing, rapidity, and completion of SIR taper. SIR levels will be monitored according to program standard operating procedures. Dose modifications of SIR for concurrent use of CYP3A4 inhibitors or inducers will be based on program standard operating procedures.
Tacrolimus (TAC) will be administered and dosed according to Moffitt Cancer Center, Department of Blood and Marrow Transplantation standard practice. Attending physician discretion is permitted with regard to timing, rapidity, and completion of TAC taper. TAC levels will be monitored according to program standard operating procedures. Dose modifications of TAC for concurrent use of CYP3A4 inhibitors or inducers will be based on program standard operating procedures.
Patients will undergo allogenic hematopoietic cell transplant (alloHCT) as a part of their standard of care treatment.