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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 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
8%
Sepsis
8%
Hypokalemia
7%
Hypophosphatemia
6%
Dyspnea
6%
Rash maculo-papular
5%
Fatigue
5%
Hypoxia
5%
Infections and infestations - Other
5%
Hypotension
5%
Hypocalcemia
4%
Acute kidney injury
4%
Catheter related infection
4%
Hyponatremia
4%
Anorexia
4%
Diarrhea
3%
Hypertension
3%
Hyperglycemia
3%
Generalized muscle weakness
3%
Hypoalbuminemia
3%
Respiratory failure
3%
Urinary tract infection
2%
Atrial fibrillation
2%
Enterocolitis infectious
2%
Epistaxis
2%
Nausea
1%
Acidosis
1%
Skin infection
1%
Soft tissue infection
1%
Multi-organ failure
1%
Confusion
1%
Pruritus
1%
Enterocolitis
1%
Non-cardiac chest pain
1%
Cardiac disorders - Other, specify
1%
Rectal hemorrhage
1%
Edema limbs
1%
Intracranial hemorrhage
1%
Investigations - Other, specify
1%
Heart failure
1%
Sinus tachycardia
1%
Supraventricular tachycardia
1%
Colitis
1%
Vomiting
1%
Upper respiratory infection
1%
Weight loss
1%
Bone pain
1%
Pain in extremity
1%
Headache
1%
Hiccups
1%
Pulmonary edema
1%
Adult respiratory distress syndrome
1%
Left ventricular systolic dysfunction
1%
Sinusitis
1%
Blood and lymphatic disorders - Other
1%
Dehydration
1%
Tumor lysis syndrome
1%
Stroke
1%
Syncope
1%
Vasovagal reaction
1%
Abdominal pain
1%
Thromboembolic event
1%
Mucositis oral
1%
Lower gastrointestinal hemorrhage
1%
Typhlitis
100%
80%
60%
40%
20%
0%
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)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
2011
Completed Phase 3
~2370

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,112,066 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 Dec 2025
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