Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients

Description

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

Leukemia, Acute, Myelodysplastic Syndromes, Myelomonocytic Leukemia, Chronic, T-cell Prolymphocytic Leukemia, CML, Myeloproliferative Disorders, Multiple Myeloma, Plasma Cell Leukemia

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Study Overview

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Study Details

Study overview

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 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)

Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients

Condition
Leukemia, Acute
Intervention / Treatment

-

Contacts and Locations

Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States, 21231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,

Ivana Gojo, MD, PRINCIPAL_INVESTIGATOR, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Record Dates

2030-03