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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:

Must not have

Chemotherapy, radiation therapy, biological therapy, and/or immunotherapy within 21 days prior to day 1 of protocol therapy

Active diarrhea due to inflammatory bowel disease or malabsorption syndrome

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

No Placebo-Only Group

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.

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.

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

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My lung function tests are good or my oxygen levels are above 92% without extra oxygen.

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I am recommended to have a stem cell transplant for my blood cancer.

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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.

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I am able to care for myself but may not be able to do active work.

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My MDS is classified as intermediate-2 or high risk.

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My condition is myelofibrosis, classified as intermediate-2 or high risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had chemotherapy, radiation, or immunotherapy in the last 21 days.

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I have ongoing diarrhea because of a bowel condition or absorption issue.

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I do not have an ongoing serious infection needing antibiotics.

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I have a history of HIV or hepatitis B/C.

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I have been diagnosed with Gilbert's disease.

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I have another active cancer.

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I am not pregnant or breastfeeding.

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I have a serious health condition that is not under control.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Graft-versus-host Disease Free Relapse Free (GRFS) at 1 Year

Secondary study objectives

Cumulative Incidence of Grade II-IV Acute GVHD

Progression Free Survival (PFS)

Other study objectives

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

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Blurred vision

Hypothyroidism

Urticaria

Hemorrhoids

Acute kidney injury

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Sorafenib Tosylate)

Arm II (Placebo)

Crossover Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 4

~1860

Melphalan

2008

Completed Phase 3

~1500