← Back to Search

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

Select...

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

Select...

I am 18 years old or older.

Select...

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:

Select...

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

Select...

I am not pregnant or breastfeeding.

Select...

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 2 trial • 14 Patients • NCT04055844

57%

Febrile neutropenia

57%

Neutrophil count decreased

21%

Sepsis

21%

Infections and infestations - Other, specify

21%

Lung infection

21%

Bacteremia

14%

Alanine aminotransferase increased

14%

Aspartate aminotransferase increased

14%

Infections and infestations - Other,

Pericardial effusion

INR increased

Intracranial hemorrhage

Sinusitis

Blood and lymphatic system

Upper gastrointestinal

Tooth infection

Hepatic infection

Blood and lymphatic system disorders - Other, specify

Typhlitis

Alanine aminotransferase

Fatigue

General disorders and administration

Disease progression

General disorders and administration site conditions - Other, specify

Syncope

Hepatobiliary disorders

Skin and subcutaneous tissue disorders - Other, specify

Gastrointestinal disorders - Other,

Injury, poisoning and procedural

Neoplasms benign, malignant and

Hypertension

White blood cell decreased

Mucositis oral

Upper gastrointestinal hemorrhage

Fever

Encephalopathy

Hepatic failure

Hyperglycemia

Gastrointestinal disorders - Other, specify

100%

80%

60%

40%

20%

Study treatment Arm

Decitabine + Ruxolitinib + DLI

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

2004

Completed Phase 3

~1720