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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients enrolled who receive hematopoietic stem cell transplantation (HCT)

Secondary outcome measures

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%

Infections and infestations - Other, specify

21%

Lung infection

21%

Bacteremia

21%

Sepsis

14%

Aspartate aminotransferase increased

14%

Alanine aminotransferase increased

14%

Infections and infestations - Other,

Mucositis oral

White blood cell decreased

Syncope

Upper gastrointestinal

Sinusitis

Hyperglycemia

Hypertension

Encephalopathy

Hepatobiliary disorders

Blood and lymphatic system

General disorders and administration

INR increased

Typhlitis

Upper gastrointestinal hemorrhage

Hepatic failure

Injury, poisoning and procedural

Blood and lymphatic system disorders - Other, specify

Fatigue

Intracranial hemorrhage

Gastrointestinal disorders - Other,

Disease progression

Fever

Skin and subcutaneous tissue disorders - Other, specify

Neoplasms benign, malignant and

Alanine aminotransferase

Tooth infection

Gastrointestinal disorders - Other, specify

Pericardial effusion

General disorders and administration site conditions - Other, specify

Hepatic infection

100%

80%

60%

40%

20%

Study treatment Arm

Decitabine + Ruxolitinib + DLI

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

~1680

Ruxolitinib

2018

Completed Phase 3

~1140

Fedratinib

2019

Completed Phase 1

~190

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,740 Previous Clinical Trials

1,847,913 Total Patients Enrolled

Anna HalpernPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

4 Previous Clinical Trials

210 Total Patients Enrolled

Media Library

Decitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04282187 — Phase 2

Myeloproliferative Neoplasm Research Study Groups: Treatment (decitabine, ruxolitinib, fedratinib, pacritinib)

Myeloproliferative Neoplasm Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT04282187 — Phase 2

Decitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04282187 — Phase 2

Frequently Asked Questions

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

Is there an opportunity for new participants to sign up in this trial?

"Affirmative. According to clinicaltrials.gov, this research protocol is presently recruiting participants, having been first shared on March 24th 2020 and most recently updated on August 18th 2022. It requires 25 study members from 1 medical centre."

Answered by AI

Is Decitabine being tested in any other clinical experiments?

"Currently, 203 research initiatives are being conducted to assess the efficacy of Decitabine. Of these active studies, 29 are in their final stage (Phase 3). Most of these investigations take place at Reggio Emilia and Foggia; however, a total of 4892 sites have been identified for clinical trials related to this medication."

Answered by AI

Has Decitabine been granted certificational acceptance from the FDA?

"Due to limited clinical data surrounding the efficacy of decitabine, it scored a 2 on our safety scale. Though some evidence exists that suggests its safety profile is not concerning, further research needs to be conducted in order for us to accurately assess its true potential."

Answered by AI

What pathologies has Decitabine shown to have a positive effect on?

"Decitabine is generally used to battle refractory anemias. Nevertheless, it can also be beneficial for patients with polycythemia vera or hydroxyurea resistance/intolerance."

Answered by AI

What is the sample size associated with this clinical trial?

"Confirmed. Based on the information provided by clinicaltrials.gov, this study is open for recruitment and has been since March 24th 2020. The most recent edition was posted on August 18th 2022; it seeks 25 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms

2020. "Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04282187.

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