NCT05823571Active, not recruitingPhase 1
Itacitinib With High-dose Posttransplantation Cyclophosphamide 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)
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 10 Apr 2023
- Start date
- 6 Jul 2023
- Primary completion date
- Mar 2028
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Myeloproliferative neoplasms, Chronic myeloid leukaemia, Myelodysplastic syndromes, Multiple myeloma, Acute myeloid leukemia
- NCT number
- NCT05823571
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 32
- From 6 Jul 2023 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any previous autologous HSCT must have occurred at least 3 months prior to start of conditioning.
- No previous allogeneic HSCT.
Other illness
- No active extramedullary leukemia or known active CNS involvement by malignancy.
- 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)
Other
- Not pregnant or breast-feeding
Who the study is looking for
- Presence of a suitable related, HLA-haploidentical (partially mismatched) stem cell donor.
- Eligible diagnoses:
- Acute leukemias in complete remission with minimal residual disease
- Myelodysplastic syndrome (MDS) with at least one poor-risk feature
- Chronic myelomonocytic leukemia with at least one poor-risk feature
- T-cell PLL in PR or better prior to transplantation.
- Tyrosine kinase-refractory CML in first chronic phase, TKI-intolerant CML in first chronic phase, or CML in second or subsequent chronic phase.
- Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis)
- 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:
- Left ventricular ejection fraction ≥ 35% or shortening fraction \> 25%
- Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST ≤ 5 x ULN
- FEV1 and FVC ≥ 40% of predicted
- ECOG performance status ≤ 2 or Karnofsky score ≥ 60
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.