Graft Vs Host Disease Clinical Trial
Official title:
A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression
Verified date | March 2024 |
Source | H. Lee Moffitt Cancer Center and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 40 |
Est. completion date | April 18, 2022 |
Est. primary completion date | January 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Must have an available 8/8 HLA-A, -B, -C, and -DRB1 matched-related or unrelated donor allogeneic hematopoietic peripheral blood stem cell graft. - Signed informed consent. - Acute myeloid leukemia, myelodysplasia, acute lymphoblastic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myeloproliferative neoplasms, Hodgkin lymphoma, or non-Hodgkin lymphoma requiring a matched allogeneic hematopoietic stem cell transplantation (HSCT). Acute Leukemia (AML or ALL) must be in complete remission defined as: <5% marrow blasts with no morphologic evidence of leukemia, no peripheral blasts, marrow >20% cellular, and peripheral absolute neutrophil count >1000/uL (platelet recovery is not required). Myelodysplasia (MDS) and chronic myeloid leukemia (CML): Must have <5% marrow blasts. Myeloproliferative neoplasms (MPN): Must have <5% peripheral / marrow blasts. Note: Prior use of a JAK2 inhibitor is allowed up to 4 weeks before day 0 of alloHCT. Hodgkin and non-Hodgkin lymphoma: Must have chemosensitive disease. - Adequate vital organ function. - Performance status: Karnofsky Performance Status Score = 80%. Donor Eligibility: - Eligible donors will include healthy sibling, relative or unrelated donors that are matched with the patient at HLA-A, B, C, and DRB1 by high resolution typing as defined by the Collaborative Trials Network. Exclusion Criteria: - Active infection not controlled with appropriate antimicrobial therapy. - History of HIV, hepatitis B, or active hepatitis C infection. - Anti-thymocyte globulin, alemtuzumab, bortezomib, or post-transplant cyclophosphamide as part of GVHD prophylaxis. - Sorror's co-morbidity factors with total score >4. - Any patient anticipating or scheduled to receive a tyrosine kinase inhibitor, FLT3 inhibitor, or JAK2 inhibitor (outside of this study) post-HCT. - QTc>450ms per Fridericia's correction. - Thrombin time (TT), prothrombin time (PT), or partial thromboplastin time (PTT) >2x upper limit of normal (ULN). - Grade 3 or higher recent (within the past 6 months) or ongoing non-QTc cardiac adverse events/comorbidities. - Grade 3 or higher recent or ongoing cardiac dysrhythmias, family history of long QT. syndrome, or serum potassium <3.0 mEq/L that is persistent and refractory to correction. - Grade 3 or higher recent or ongoing bleeding events. - Symptomatic or uncontrolled cardiovascular disease, myocardial infarction or severe/unstable angina within the past 6 months, or New York Heart Association (NYHA) Class III or IV congestive heart failure. |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | CTI BioPharma, National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | STAT Activity | STAT3 activity in circulating CD4+ T-cells. This is equivalent to 5.5 tablespoons of blood for each assessment. Peripheral blood mononuclear cells (PBMC) will be isolated by Ficoll density gradient. PBMCs will be stimulated with IL-6 for 20 minutes to activate STAT3. Phosphoproteins will be analyzed within T-cells by flow cytometry.
Result reported is %pSTAT3+CD4+T cells at day +21. |
up to 21 days | |
Secondary | Incidence of Acute GVHD | Cumulative incidence of acute GVHD . Participants will be monitored for clinical signs of acute GVHD. Acute GVHD will be graded per the 1995 consensus guidelines. | up to 100 days |
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