ACTIVE_NOT_RECRUITING

Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients

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Conditions

Leukemia, AcuteMyelodysplastic SyndromesMyelomonocytic Leukemia, ChronicT-cell Prolymphocytic LeukemiaCMLMyeloproliferative DisordersMultiple MyelomaPlasma Cell Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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)

Quick Facts

Study Start:2023-07-06
Study Completion:2030-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05823571

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.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Presence of a suitable related, HLA-haploidentical (partially mismatched) stem cell donor.
  2. * Eligible diagnoses:
  3. 1. Acute leukemias in complete remission with minimal residual disease
  4. 2. Myelodysplastic syndrome (MDS) with at least one poor-risk feature
  5. 3. Chronic myelomonocytic leukemia with at least one poor-risk feature
  6. 4. T-cell PLL in PR or better prior to transplantation.
  7. 5. Tyrosine kinase-refractory CML in first chronic phase, TKI-intolerant CML in first chronic phase, or CML in second or subsequent chronic phase.
  8. 6. Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis)
  9. 7. Multiple myeloma or plasma cell leukemia with a PR or better to the last treatment regimen
  10. * Age ≥ 60 years.
  11. * Adequate end-organ function as measured by:
  12. 1. Left ventricular ejection fraction ≥ 35% or shortening fraction \> 25%
  13. 2. Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST ≤ 5 x ULN
  14. 3. FEV1 and FVC ≥ 40% of predicted
  15. * ECOG performance status ≤ 2 or Karnofsky score ≥ 60
  1. * No active extramedullary leukemia or known active CNS involvement by malignancy.
  2. * Any previous autologous HSCT must have occurred at least 3 months prior to start of conditioning.
  3. * No previous allogeneic HSCT.
  4. * Not pregnant or breast-feeding
  5. * No uncontrolled infection.
  6. * No known HIV infection.
  7. * No active replicating HBV or HCV infection detected by PCR that requires treatment or at risk for HBV reactivation (positive HBsAg)

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-06
Study Completion Date2030-03

Study Record Updates

Study Start Date2023-07-06
Study Completion Date2030-03

Terms related to this study

Additional Relevant MeSH Terms

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