Using itacitinib to prevent complications after stem cell transplantation in older patients
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 study is testing if giving itacitinib to older patients before and after stem cell transplants can help prevent complications like cytokine release syndrome and reduce the need for long-term immunosuppressive therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | itacitinib, cyclophosphamide |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05823571 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of itacitinib, an immunosuppressant, in older patients undergoing non-myeloablative peripheral blood stem cell transplantation (PBSCT) for blood cancers. The study aims to determine if administering itacitinib before and after transplantation can reduce the risk of cytokine release syndrome (CRS) and the need for prolonged immunosuppressive therapy. Participants will be monitored for complications such as acute and chronic graft-versus-host disease (GVHD) and non-relapse mortality. The trial focuses on patients aged 60 and older who have a suitable related stem cell donor.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 years and older with specific blood cancers and a suitable HLA-haploidentical stem cell donor.
Not a fit: Patients who are younger than 60 years or do not have a suitable stem cell donor may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce severe complications and improve outcomes for older patients undergoing stem cell transplantation.
How similar studies have performed: Other studies have shown promising results with similar immunosuppressive approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Baltimore, Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Ivana Gojo, MD — Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study coordinator: Ivana Gojo, MD
- Email: igojo1@jhmi.edu
- Phone: 410-502-8775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.