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)

What's the purpose of this trial?

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).

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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)

Additional Trial Information

Phase 1

Enrollment: 32 patients (estimated)

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Trial Locations

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Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine

Baltimore, MD

Open and Accepting
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