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Janus Kinase (JAK) Inhibitor

Itacitinib + Tacrolimus + Sirolimus for Leukemia

Phase 2
Waitlist Available
Led By Haris Ali
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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). If unable to perform pulmonary function tests: oxygen (O2) saturation > 92% on room air.
Patients with neoplastic hematologic disorders with indication of allogeneic transplant according to the standard guidelines as follows:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of stem cell infusion to the date of death, disease relapse/progression, or last follow-up, whichever occurs first, assessed at 1 year post transplant
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can prevent GVHD in patients with leukemia, myelodysplastic syndrome or myelofibrosis.

Who is the study for?
This trial is for adults with acute leukemia, myelodysplastic syndrome, or myelofibrosis planning to undergo stem cell transplantation. Participants need a matched donor, good organ function, and must not be pregnant or breastfeeding. They should agree to use birth control and cannot have other active cancers or uncontrolled illnesses.Check my eligibility
What is being tested?
The study tests if adding Itacitinib to standard GVHD prevention drugs Tacrolimus and Sirolimus can better prevent graft-versus-host disease in patients receiving reduced intensity conditioning donor stem cell transplants. The effectiveness of this combination will also be assessed through quality-of-life questionnaires.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's response such as inflammation in various organs, increased risk of infections due to immunosuppression from Tacrolimus and Sirolimus, potential liver enzyme elevations, gastrointestinal symptoms like diarrhea, and general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung function tests are good or my oxygen levels are above 92% without extra oxygen.
Select...
I am recommended to have a stem cell transplant for my blood cancer.
Select...
My leukemia is in its first or later complete response, or it's active but with less than 5% of cancer cells in my bone marrow.
Select...
I am able to care for myself but may not be able to do active work.
Select...
My MDS is classified as intermediate-2 or high risk.
Select...
My condition is myelofibrosis, classified as intermediate-2 or high risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of transplantation to the first time of observing following events: grade 3-4 acute graft versus host disease (gvhd), chronic gvhd requiring systemic treatment, relapse, or death, whichever occurs first, assessed at 1 year post transplant.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of transplantation to the first time of observing following events: grade 3-4 acute graft versus host disease (gvhd), chronic gvhd requiring systemic treatment, relapse, or death, whichever occurs first, assessed at 1 year post transplant. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Graft-versus-host Disease Free Relapse Free (GRFS) at 1 Year
Secondary outcome measures
Cumulative Incidence of Grade II-IV Acute GVHD
Progression Free Survival (PFS)
Other outcome measures
Biomarker analysis
Hematologic recovery, donor cell engraftment and immune reconstitution

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Acute kidney injury
2%
Blurred vision
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (itacitinib adipate, tacrolimus, sirolimus)Experimental Treatment7 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Melphalan
2008
Completed Phase 3
~1500
Sirolimus
2013
Completed Phase 4
~2750
Tacrolimus
2011
Completed Phase 4
~4740

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,401 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,608 Total Patients Enrolled
Haris AliPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
3 Previous Clinical Trials
58 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ultimate outcomes are being sought through this medical experiment?

"This medical trial's primary aim is to evaluate cumulative incidence of graft-versus-host disease free relapse free (GRFS) over a 30 day period. Secondary objectives include assessment of the likelihood and severity of relapses/progressions, non-relapse mortality (NRM), and chronic GvHD using NIH Consensus Staging criteria."

Answered by AI

How many people are being recruited to partake in this research?

"The opportunity to join this trial is no longer available, as the research project was first listed on November 11th 2020 and last updated on June 7th 2022. However, presently there are 2861 clinical trials related to primary myelofibrosis that are actively seeking participants and 575 studies for Quality-of-Life Assessment still open for enrolment."

Answered by AI

What previous investigations have explored Quality-of-Life Assessment?

"Currently, the field of Quality-of-Life Assessment is seeing 575 active clinical trials with 53 in their final phase. Philadelphia has a particularly high concentration of these studies, though there are 6128 sites offering research for this condition globally."

Answered by AI

Is enrollment still accessible for this research endeavor?

"This study is no longer accepting patients, having been initially posted on November 11th 2020 and last edited June 7th 2022. If seeking additional trials for primary myelofibrosis, there are 2861 studies currently enrolling; 575 of those involve Quality-of-Life Assessment."

Answered by AI

Does this research extend to individuals aged 30 and above?

"This trial is open to participants who are aged 18 or over, but under 75 years of age."

Answered by AI

Who meets the criteria for enrollment in this research program?

"This clinical trial is accepting 59 myelofibrosis patients aged 18 to 75. All participants must have documented informed consent from themselves or their legal representative, a total bilirubin level of no more than 1.5x the upper limit of normal (or lower if they suffer from Gilbert's disease), a Karnosky Performance Status score of 70% or higher, and either an 8/8 allele matched donor or related donor willing to donate bone marrow stem cells. Additionally, all entrants must pass tests for acute leukemia in complete response one & two with less than 5% BM blasts as well as Aspartate Aminotransfer"

Answered by AI

Does the FDA recognize Quality-of-Life Assessment as a reliable form of evaluation?

"Quality-of-Life Assessments is rated as a 2 out of 3 on the safety scale because this particular Phase 2 trial has some data that supports its safety, but there isn't any supporting efficacy."

Answered by AI

How is Quality-of-Life Assessment traditionally employed to evaluate a patient's condition?

"Quality-of-Life Assessment is an efficient treatment for dermatitis, atopic, lymphoma and bronchogenic carcinoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation
2020. "Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04339101.
All > Gvhd > Myelofibrosis
~13 spots leftby Apr 2025
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