ACTIVE_NOT_RECRUITING

Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants

Talk to us

Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic SyndromeMyeloproliferative NeoplasmPrimary MyelofibrosisSecondary Myelofibrosis

Quick Navigation

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 clinical trial evaluates the safety and effectiveness of adding itacitinib to cyclophosphamide and tacrolimus for the prevention of graft versus host disease (GVHD) in patients undergoing hematopoietic stem cell transplant. Itacitinib is an enzyme inhibitor that may regulate the development, proliferation, and activation of immune cells important for GVHD development. Cyclophosphamide and tacrolimus are immunosuppressive agents that may prevent GVHD in patients who receive stem cell transplants. Giving itacitinib in addition to cyclophosphamide and tacrolimus may be more effective at preventing GVHD in patients receiving hematopoietic stem cell transplants.

Official Title

Single Center Pilot Study to Investigate the Efficacy of Adding Itacitinib to Post-Transplant Cyclophosphamide as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning Matched Donor Hematopoietic Cell Transplantation With Peripheral Blood Stem Cells as Graft Source

Quick Facts

Study Start:2022-11-23
Study Completion:2026-05-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05364762

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:Not specified to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented informed consent of the participant and/or legally authorized representative
  2. * Assent, when appropriate, will be obtained per institutional guidelines
  3. * Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  4. * If unavailable, exceptions may be granted with study principal investigator (PI) approval
  5. * Age: =\< 80 years
  6. * Note: Patients \> 70 years of age must have Karnofsky performance status \>= 80 and HCT-comorbidity index (CI) =\< 2
  7. * Karnofsky performance status \>= 70%
  8. * Patients with the following diagnosis, eligible to undergo allogeneic HCT from an 8/8 match related/unrelated donor (A, B, C, DR by high resolution typing)
  9. * Acute leukemias (acute myeloid leukemia \[AML\] or acute lymphoblastic leukemia \[ALL\]) in complete remission with bone marrow (BM) blast of \< 5%
  10. * Myelofibrosis (MF): Primary or secondary with high- or intermediate-2 risk per Dynamic International Prognostic Scoring System (DIPSS)
  11. * Myelodysplastic syndrome (blast \< 10%)
  12. * Myeloproliferative neoplasm (MPN) other than MF needing HCT
  13. * Chronic myelomonocytic leukemia (CMML)
  14. * Total bilirubin =\< 2 x upper limit of normal (ULN) (unless has Gilbert's disease) (within 30 days prior to day 1 of protocol therapy unless otherwise stated)
  15. * Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) \< 5 x ULN (within 30 days prior to day 1 of protocol therapy unless otherwise stated)
  16. * Creatinine clearance of \>= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 30 days prior to day 1 of protocol therapy unless otherwise stated)
  17. * Left ventricular ejection fraction (LVEF) \>= 50%
  18. * Note: To be performed within 30 days prior to day 1 of protocol therapy
  19. * If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lungs for carbon monoxide (DLCO) (diffusion capacity) \>= 50% of predicted (corrected for hemoglobin) (within 30 days prior to day 1 of protocol therapy)
  20. * If unable to perform pulmonary function tests: O2 saturation \> 92% on room air (within 30 days prior to day 1 of protocol therapy)
  21. * Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis rapid plasma reagin (RPR) (within 30 days prior to day 1 of protocol therapy)
  22. * If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed OR
  23. * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable
  24. * Meets other institutional and federal requirements for infectious disease titer requirements
  25. * Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
  26. * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 30 days prior to day 1 of protocol therapy)
  27. * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  28. * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
  29. * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
  1. * Prior allogeneic HCT
  2. * Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy
  3. * Note: Conditioning regimen within 21 days prior to day 1 of protocol therapy is not considered as an exclusion criterion. Patients on maintenance chemotherapy are not excluded
  4. * Other investigational drugs for treatment of GVHD
  5. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents
  6. * Psychological issues, no appropriate caregivers identified, or non-compliant to medication
  7. * Clinically significant uncontrolled illness
  8. * Uncontrolled infection (bacterial, viral, fungal)
  9. * Other active malignancy
  10. * Females only: Pregnant or breastfeeding
  11. * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  12. * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Contacts and Locations

Principal Investigator

Monzr M Al Malki
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Monzr M Al Malki, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

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 Date2022-11-23
Study Completion Date2026-05-22

Study Record Updates

Study Start Date2022-11-23
Study Completion Date2026-05-22

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome
  • Myeloproliferative Neoplasm
  • Primary Myelofibrosis
  • Secondary Myelofibrosis