Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CML | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Leukemia, Acute | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myelomonocytic Leukemia, Chronic | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Plasma Cell Leukemia | Plasma Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
| T-cell Prolymphocytic Leukemia |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Itacitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Itacitinib
- description
- Itacitinib will be given at 200 mg orally daily from day -3 to day 90. Itacitinib will be given in conjunction with one of four different regimens for immunosuppression. These 4 regimens are listed in Table 2, Section 5.2 of the protocol. Itacitinib may continue beyond day +90 if there is GVHD. NOTE: If patient develops GVHD requiring treatment after all immune suppression, including itacitinib, is stopped on day +90, the itacitinib will not be restarted and the patient will be treated per standard of care.
- interventionNames
- Drug: Itacitinib
Primary outcomes (4)
- measure
- Number of participant deaths
- timeFrame
- 14 days
- description
- Number of participant deaths will be used to assess the efficacy of itacitinib in preventing the occurrence of death.
- measure
- Number of participants with grade 3 or higher CRS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available