Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients

• Status: Not yet recruiting
• Trial end date: 2030-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Incyte Corporation

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)