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Anti-metabolites

Decitabine + JAK Inhibitors for Advanced Myeloproliferative Disorders

Phase 2

Recruiting

Led By Anna Halpern

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky >= 60%

Age >= 18 years

Must not have

For patients planning to receive fedratinib: concurrent use of strong and moderate CYP3A4 inducers or dual CYP3A4 and CYP2C19 inhibitors that cannot be discontinued

Females who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether a combination of decitabine, ruxolitinib, and fedratinib may be more effective than chemotherapy or no treatment in patients with myeloproliferative neoplasms.

Who is the study for?

Adults with advanced myeloproliferative neoplasms, including those with certain types of leukemia and bone marrow disorders. Participants must have a specific level of blast cells in their blood or bone marrow and be considered potential candidates for stem cell transplant. They should not have had previous chemotherapy for these conditions but may have used other treatments like hydroxyurea.

What is being tested?

The trial is testing the effectiveness of decitabine combined with either ruxolitinib, fedratinib, or pacritinib before undergoing a stem cell transplant. The goal is to see if this treatment can better prepare patients' bodies for the transplant compared to traditional multi-agent chemotherapy or no pre-transplant therapy at all.

What are the potential side effects?

Potential side effects include reactions related to immune suppression such as infection risks, possible organ inflammation due to enzyme inhibition by ruxolitinib, fedratinib, or pacritinib, and typical chemotherapy-related issues like nausea, fatigue, and blood count abnormalities from decitabine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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I have a history of blood disorder with at least 5% immature blood cells.

Exclusion Criteria

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

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I am not taking strong drugs that affect fedratinib's action and can't stop them.

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I am not pregnant or breastfeeding.

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I am taking a strong medication that cannot be stopped and my platelet count is below 50,000.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Mutational profiling

Overall survival

Overall survival regardless of transplant status

+5 more

Side effects data

From 2022 Phase 3 trial • 727 Patients • NCT02085408

98%

White blood cell decreased

96%

Platelet count decreased

94%

Neutrophil count decreased

91%

Anemia

73%

Aspartate aminotransferase increased

71%

Alanine aminotransferase increased

59%

Blood bilirubin increased

55%

Febrile neutropenia

46%

Alkaline phosphatase increased

34%

Hypomagnesemia

26%

Creatinine increased

23%

Lymphocyte count decreased

12%

Lung infection

12%

Hypermagnesemia

Sepsis

Hypokalemia

Hypophosphatemia

Dyspnea

Rash maculo-papular

Fatigue

Hypoxia

Infections and infestations - Other

Hypotension

Hypocalcemia

Acute kidney injury

Catheter related infection

Hyponatremia

Anorexia

Diarrhea

Hypertension

Hyperglycemia

Generalized muscle weakness

Hypoalbuminemia

Respiratory failure

Urinary tract infection

Atrial fibrillation

Enterocolitis infectious

Epistaxis

Nausea

Acidosis

Skin infection

Soft tissue infection

Multi-organ failure

Confusion

Pruritus

Enterocolitis

Non-cardiac chest pain

Cardiac disorders - Other, specify

Rectal hemorrhage

Edema limbs

Intracranial hemorrhage

Investigations - Other, specify

Heart failure

Sinus tachycardia

Supraventricular tachycardia

Colitis

Vomiting

Upper respiratory infection

Weight loss

Bone pain

Pain in extremity

Headache

Hiccups

Pulmonary edema

Adult respiratory distress syndrome

Left ventricular systolic dysfunction

Sinusitis

Blood and lymphatic disorders - Other

Dehydration

Tumor lysis syndrome

Stroke

Syncope

Vasovagal reaction

Abdominal pain

Thromboembolic event

Mucositis oral

Lower gastrointestinal hemorrhage

Typhlitis

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Induction: Clofarabine)

Arm F (Maintenance: Decitabine)

Arm A (Induction: Daunorubicin + Cytarabine)

Arm C (Consolidation: Cytarabine)

Arm D (Consolidation: Clofarabine)

Arm E (Maintenance: Observation)

Arm G (Transplant)

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 (decitabine, ruxolitinib, fedratinib, pacritinib)Experimental Treatment5 Interventions

Patients receive decitabine IV QD over 1 hour on days 1-10, and either ruxolitinib PO BID, fedratinib PO daily, or pacritinib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pacritinib

2017

Completed Phase 2

~330

Decitabine

2011

Completed Phase 3

~2370