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Active Not Recruiting
NCT05823571
Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients
Conditions: Leukemia, Acute, Myelodysplastic Syndromes, Myelomonocytic Leukemia, Chronic, T-cell Prolymphocytic Leukemia, CML, Myeloproliferative Disorders, Multiple Myeloma, Plasma Cell Leukemia
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 32
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Location: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
Summary
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).
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT05823571). StuddyBuddy aggregates publicly available trial information.