Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 75 Years|
- - Documented informed consent of the participant and/or legally authorized representative.
- - Assent, when appropriate, will be obtained per institutional guidelines.
- - Agreement to allow the use of archival tissue from diagnostic tumor biopsies.
- - If unavailable, exceptions may be granted with study principal investigator (PI) approval.
- - Performance status: Karnofsky >= 70% - Patients with neoplastic hematologic disorders with indication of allogeneic transplant according to the standard guidelines as follows: - Acute leukemia (AL) in first complete response (CR1) or subsequent complete response (CR) or active disease with bone marrow (BM) blast of < 5% - Myelodysplastic syndrome (MDS) with intermediate-2 or high risk per International Prognostic Scoring System (IPSS) or.
- - Myelofibrosis; primary or secondary if intermediate-2 or high risk per Dynamic International Prognostic Scoring System (DIPPS) - All candidates for this study must have a matched related donor (MRD) who is willing to donate BM or peripheral blood stem cells or an 8/8 allele matched unrelated donor (MUD) - Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated.
- - Aspartate aminotransferase (AST) =< 2.5 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated.
- - Alanine aminotransferase (ALT) =< 2.5 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated.
- - Creatinine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated.
- - Left ventricular ejection fraction (LVEF) >= 50% - Note: To be performed within 28 days prior to day 1 of protocol therapy.
- - If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) (diffusion capacity) >= 50% of predicted (corrected for hemoglobin).
- - Note To be performed within 28 days prior to day 1 of protocol therapy.
- - Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combination (combo), hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin measurement [RPR]) - If HCV positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed.
- - Meets other institutional and federal requirements for infectious disease titer requirements.
- - Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy.
- - Women of childbearing potential (WOCBP): negative urine or serum pregnancy test.
- - 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.
- - Childbearing potential defined as not being surgically sterilized (men and women)
or have not been free from menses for > 1 year (women only)
Exclusion Criteria:- Chemotherapy, radiation therapy, biological therapy, and/or immunotherapy within 21 days prior to day 1 of protocol therapy.
- - Note: Conditioning regimen within 21 days prior to day 1 of protocol therapy is not considered as an exclusion criterion.
- - History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
- - Psychological issues, no appropriate caregivers identified, or non-compliant to medication.
- - Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician) - Active diarrhea due to inflammatory bowel disease or malabsorption syndrome.
- - Clinically significant uncontrolled illness.
- - Active, uncontrolled systemic infection (bacterial, viral, or fungal) requiring antibiotics.
- - Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection.
- - Diagnosis of Gilbert's disease.
- - Other active malignancy.
- - Females only: Pregnant or breastfeeding.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|City of Hope Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||City of Hope Comprehensive Cancer Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Acute Leukemia, Hematologic and Lymphocytic Disorder, Myelodysplastic Syndrome, Primary Myelofibrosis, Secondary Myelofibrosis|
- I. Following a patient safety lead-in, estimate graft-versus-host disease free relapse free (GRFS) survival at 1- year post allogeneic stem cell transplantation (alloHCT).
- I. Estimate the cumulative incidence of acute graft-versus-host disease (aGVHD) and non-relapse mortality (NRM) at 100-days post-transplant.
- II. Estimate the cumulative incidence of chronic GVHD at 1- and 2-years post-transplant.
- III. Estimate the probabilities of overall and progression-free survival (OS/PFS) at 1- and 2-years post-transplant.
- IV. Estimate rate of infection and development of second malignancies including lymphoproliferative disorders at 1- and 2-years post-transplant.
- V. Assess patients' quality of life (QOL) at day 100 and 1 year post alloHCT.
- I. Characterize and evaluate hematologic recovery, donor cell engraftment and immune reconstitution by cell count and flow cytometry of lymphocyte subsets.
- II. Characterize changes in aGVHD biomarkers (Reg-3alpha, TNF-RI, and ST2) and a composite biomarker panel (IL2Ralpha, TNF-R1, IL-8, and hepatocyte growth factor), JAK-regulated pro-inflammatory cytokines (i.e., IL-6, TNFalpha, CRP, Beta2 Microglobulin, and IFNgamma) and STAT3 phosphorylation (downstream of JAK signaling) over time and by aGVHD status/grade.
Experimental: Treatment (itacitinib adipate, tacrolimus, sirolimus)
RIC: Patients receive fludarabine via infusion on days -9 to -5 and melphalan on day -4 in the absence of disease progression or unacceptable toxicity. ALLOGENEIC HSCT: Patients undergo HSCT on day 0. GVHD PROPHYLAXIS: Patients receive itacitinib PO QD beginning on day -3 and continuing until day 100 in the absence of disease progression or unacceptable toxicity. Patients also receive tacrolimus IV or PO and sirolimus PO beginning day -3 and continuing until day 100 with a taper in the absence of disease progression or unacceptable toxicity.
Drug: - Fludarabine
Given via infusion
Drug: - Itacitinib Adipate
Drug: - Melphalan
Other: - Quality-of-Life Assessment
Other: - Questionnaire Administration
Drug: - Sirolimus
Drug: - Tacrolimus
Given IV or PO
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.