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||N/A - 80 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.
- - Age: =< 80 years.
- - Note: Patients > 70 years of age must have Karnofsky performance status >= 80 and HCT-comorbidity index (CI) =< 2.
- - Karnofsky performance status >= 70% - 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) - Acute leukemias (acute myeloid leukemia [AML] or acute lymphoblastic leukemia [ALL]) in complete remission with bone marrow (BM) blast of < 5% - Myelofibrosis (MF): Primary or secondary with high- or intermediate-2 risk per Dynamic International Prognostic Scoring System (DIPSS) - Myelodysplastic syndrome (blast < 10%) - Myeloproliferative neoplasm (MPN) other than MF needing HCT.
- - Chronic myelomonocytic leukemia (CMML) - 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) - 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) - 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) - Left ventricular ejection fraction (LVEF) >= 50% - Note: To be performed within 30 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 lungs for carbon monoxide (DLCO) (diffusion capacity) >= 50% of predicted (corrected for hemoglobin) (within 30 days prior to day 1 of protocol therapy) - If unable to perform pulmonary function tests: O2 saturation > 92% on room air (within 30 days prior to day 1 of protocol therapy) - 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) - If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed OR.
- - If seropositive for HIV, HCV or HBV, nucleic acid 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 (within 30 days prior to day 1 of protocol therapy) - If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- - 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:- Prior allogeneic HCT.
- - Chemotherapy, radiation therapy, biological therapy, 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.
- - Other investigational drugs for treatment of GVHD.
- - History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents.
- - Psychological issues, no appropriate caregivers identified, or non-compliant to medication.
- - Clinically significant uncontrolled illness.
- - Uncontrolled infection (bacterial, viral, fungal) - 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.
|Monzr M Al Malki|
|Principal Investigator Affiliation||City of Hope Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Primary Myelofibrosis, Secondary Myelofibrosis|
- I. Safety lead-in: Determine if shortening tacrolimus administration period to 60 days (day +65 post-hematopoietic cell transplantation [HCT]), when combined with post-transplant cyclophosphamide (PTCy) and itacitinib at a fixed dose level as graft-versus-host disease (GVHD) prophylaxis, is safe and effective after mobilized peripheral blood stem cell (PBSC) allogeneic hematopoietic cell transplantation (HCT) from a matched related/unrelated donor, as assessed by grade 3-4 GVHD as dose limiting toxicity.
- II. Following the safety lead-in, evaluate the efficacy of PTCy, itacitinib and tacrolimus GVHD prophylaxis, as assessed by 1-year GVHD-free relapse-free survival (GRFS).
- I. Evaluate the safety of this regimen by assessing: Ia.
- II. Estimate overall survival (OS), progression-free survival (PFS), cumulative incidences of relapse/disease progression, and non-relapse mortality (NRM) at 100 days, and 1-year post-transplant.
- III. Estimate rates of acute and chronic GvHD, infections, and neutrophil recovery.
- I. Donor cell engraftment will be assessed by count monitoring and short tandem repeat (STR) chimerism analysis on days +30 and day +100.
- II. Describe the kinetics of immune cell recovery.
- III. Evaluate patient's quality of life on day +100, 6 months and one-year post-HCT.
- IV. Pharmacokinetics: serial blood sampling will be done to evaluate the steady-state pharmacokinetics of itacitinib after PTCy.
- V. Describe the kinetics of GVHD biomarkers, JAK-related inflammatory cytokines and STAT phosphorylation.
- VI. Evaluate and describe the cytokine release syndrome (CRS) post-HCT by assessing the incidence, frequency, and severity of CRS.
- VII. Obtain a preliminary estimate of gut microbiome diversity at baseline (preferably before fludarabine administration), and then on days +14, +30, and +100.
Experimental: Prevention (PBSCs, cyclophosphamide, itacitinib, tacrolimus)
Patients undergo peripheral blood stem cell infusion on day 0. Patients receive cyclophosphamide IV QD on days 3 and 4, itacitinib PO QD on days 5-100, and tacrolimus IV or PO on days 6-65.
Drug: - Cyclophosphamide
Drug: - Itacitinib
Procedure: - Peripheral Blood Stem Cell Transplantation
Undergo peripheral blood stem cell infusion
Other: - Quality-of-Life Assessment
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.