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Anti-metabolites

Decitabine for Myelofibrosis

Phase 2
Waitlist Available
Led By Olatoyosi M Odenike
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have anemia (hemoglobin < 11 g/dL) or palpable splenomegaly
Patients with palpable splenomegaly must have spleen size documented ultrasonographically
Must not have
Prior therapy with decitabine
Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 weeks (6 cycles)
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at the side effects and effectiveness of decitabine in treating patients with myelofibrosis, a cancer of the blood system. Decitabine may block proteins that turn certain genes off in various cancers including myelofibrosis.

Who is the study for?
This trial is for adults with advanced myelofibrosis, a type of blood cancer. Eligible participants may have had previous treatments but not with decitabine. They should be in stable health otherwise, not pregnant or nursing, and willing to use contraception. Key criteria include specific diagnostic features of myelofibrosis, anemia or noticeable spleen enlargement.
What is being tested?
The trial is testing the effectiveness and side effects of decitabine in treating advanced myelofibrosis. Decitabine might block proteins that silence genes involved in this cancer's development. Participants will also undergo lab biomarker analysis to monitor responses.
What are the potential side effects?
Decitabine can cause side effects like fatigue, fever, nausea, low blood cell counts leading to increased infection risk or bleeding problems, lung complications and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have anemia or an enlarged spleen.
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My enlarged spleen's size has been measured with an ultrasound.
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I can take care of myself but might not be able to do heavy physical work.
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My condition is confirmed myelofibrosis of any subtype.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with decitabine before.
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I am HIV-positive and on combination anti-retroviral therapy.
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I do not have any unmanaged ongoing illnesses.
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I have a known brain or spinal cord condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 weeks (6 cycles)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 weeks (6 cycles) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Toxicities, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Response Rate (Complete Response, Partial Response, or Hematologic Improvement.
Secondary study objectives
CD34+ Cells
CXCR4
Hemoglobin F

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,
7%
Pericardial effusion
7%
INR increased
7%
Intracranial hemorrhage
7%
Sinusitis
7%
Blood and lymphatic system
7%
Upper gastrointestinal
7%
Tooth infection
7%
Hepatic infection
7%
Blood and lymphatic system disorders - Other, specify
7%
Typhlitis
7%
Alanine aminotransferase
7%
Fatigue
7%
General disorders and administration
7%
Disease progression
7%
General disorders and administration site conditions - Other, specify
7%
Syncope
7%
Hepatobiliary disorders
7%
Skin and subcutaneous tissue disorders - Other, specify
7%
Gastrointestinal disorders - Other,
7%
Injury, poisoning and procedural
7%
Neoplasms benign, malignant and
7%
Hypertension
7%
White blood cell decreased
7%
Mucositis oral
7%
Upper gastrointestinal hemorrhage
7%
Fever
7%
Encephalopathy
7%
Hepatic failure
7%
Hyperglycemia
7%
Gastrointestinal disorders - Other, specify
100%
80%
60%
40%
20%
0%
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)Experimental Treatment2 Interventions
Patients receive decitabine SC on days 1-5 and 8-12. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,924 Previous Clinical Trials
41,017,930 Total Patients Enrolled
82 Trials studying Primary Myelofibrosis
7,640 Patients Enrolled for Primary Myelofibrosis
Olatoyosi M OdenikePrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center

Media Library

Decitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00095784 — Phase 2
Primary Myelofibrosis Research Study Groups: Treatment (decitabine)
Primary Myelofibrosis Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT00095784 — Phase 2
Decitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00095784 — Phase 2
~1 spots leftby Nov 2025
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