Multiple Myeloma Clinical Trial
Official title:
Phase 1a/1b Study of Itacitinib (INCB039110) for Cytokine Release Syndrome Prevention and Minimization of Immunosuppression Following Nonmyeloablative Related Partially HLA-mismatched Peripheral Blood Stem Cell Transplant (PBSCT) With High-dose Posttransplantation Cyclophosphamide in Older Patients (Age 60 Years)
This research is being done to learn whether drug called itacitinib, which is a novel inflammation- and immune-lowering drug (immunosuppressant), can be given before and after non-myeloablative peripheral blood stem cell transplantation (PBSCT; also known as a 'mini' transplant) to help prevent certain complications such as cytokine release syndrome (CRS) for patients with blood cancers, using peripheral blood from a relative. The investigators will also examine if by using itacitinib the investigators can reduce the duration of MMF (other immune suppressive drug administration posttransplant).
Status | Recruiting |
Enrollment | 32 |
Est. completion date | March 2030 |
Est. primary completion date | March 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Presence of a suitable related, HLA-haploidentical (partially mismatched) stem cell donor. - Eligible diagnoses: 1. Acute leukemias in complete remission with minimal residual disease 2. Myelodysplastic syndrome (MDS) with at least one poor-risk feature 3. Chronic myelomonocytic leukemia with at least one poor-risk feature 4. T-cell PLL in PR or better prior to transplantation. 5. Tyrosine kinase-refractory CML in first chronic phase, TKI-intolerant CML in first chronic phase, or CML in second or subsequent chronic phase. 6. Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis) 7. Multiple myeloma or plasma cell leukemia with a PR or better to the last treatment regimen - Age = 60 years. - Adequate end-organ function as measured by: 1. Left ventricular ejection fraction = 35% or shortening fraction > 25% 2. Bilirubin = 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST = 5 x ULN 3. FEV1 and FVC = 40% of predicted - ECOG performance status = 2 or Karnofsky score = 60 Exclusion Criteria: - No active extramedullary leukemia or known active CNS involvement by malignancy. - Any previous autologous HSCT must have occurred at least 3 months prior to start of conditioning. - No previous allogeneic HSCT. - Not pregnant or breast-feeding - No uncontrolled infection. - No known HIV infection. - No active replicating HBV or HCV infection detected by PCR that requires treatment or at risk for HBV reactivation (positive HBsAg) |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Incyte Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participant deaths | Number of participant deaths will be used to assess the efficacy of itacitinib in preventing the occurrence of death. | 14 days | |
Primary | Number of participants with grade 3 or higher CRS | Number of participants with grade 3 or higher CRS will be used to assess the efficacy of itacitinib in preventing the development of severe (grade 3 or higher) cytokine release syndrome (CRS). | 14 days | |
Primary | Number of participants with grade 1-2 CRS that requires additional CRS-directed treatment | Number of participants with grade 1-2 CRS that requires additional CRS-directed treatment will be used to assess the efficacy of itacitinib in preventing the development of grade 1-2 CRS that requires additional CRS-directed treatment. | 14 days | |
Primary | Number of participants with treatment limiting toxicities by Day 60 | Number of participants with treatment limiting toxicities by Day 60 will be used to identify the safe PTCy-based immunosuppressive regimen that incorporates itacitinib with tacrolimus and a reduced duration of immunosuppression with mycophenolate (MMF). | 60 days |
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