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Anti-metabolites

Decitabine for Myelofibrosis

Q: What are Decitabine's most popular uses?

Decitabine is often used to treat patients in the ipss risk category intermediate-2. This medication can also help patients with other blood disorders like refractory anemias and ipss high risk.

Q: Is recruitment still underway for subjects of this research?

This study is not currently enrolling patients. The listing for this clinical trial was first posted on September 29th, 2004 and updated most recently on June 28th, 2022. Other active trials studying primary <a href="https://www.withpower.com/clinical-trials/myelofibrosis">myelofibrosis</a> and Decitabine are presently recruiting; 95 and 106 studies respectively.

Q: What is the current thinking on Decitabine's efficacy?

As of now, there are one hundred and six clinical trials involving Decitabine. Out of those, sixteen have progressed to Phase 3 testing. The majority of these studies originated in Philadelphia, but there are 1,529 total locations running active trials for this medication.

Q: What is the FDA's most recent stance on Decitabine?

Decitabine is a phase 2 clinical trial medication, meaning that while there is some evidence of its safety, none exists for its efficacy.

Q: Is this clinical trial widely available in North America?

Currently, there are 14 sites recruiting patients for this clinical trial. These locations include University of <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a>/Greenebaum <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in Baltimore, Ingalls Memorial Hospital in Harvey, and Southern <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a> University School of Medicine in South Bend.

Q: How many guinea pigs are they letting in on this one?

Unfortunately, this trial is not currently admitting patients. The study was originally posted on September 29th, 2004 and was last updated on June 28th, 2022. However, there are many other ongoing trials that might be a good fit - for example, there are 95 trials related to primary <a href="https://www.withpower.com/clinical-trials/myelofibrosis">myelofibrosis</a> and 106 Decitabine studies recruiting patients right now.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 weeks (6 cycles)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have anemia or an enlarged spleen.

Select...

My enlarged spleen's size has been measured with an ultrasound.

Select...

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

Select...

My condition is confirmed myelofibrosis of any subtype.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 weeks (6 cycles)

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

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

Primary outcome measures

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 outcome measures

CD34+ Cells

CXCR4

Hemoglobin F

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)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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,132 Total Patients Enrolled

69 Trials studying Primary Myelofibrosis

6,820 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

Frequently Asked Questions

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

What are Decitabine's most popular uses?

"Decitabine is often used to treat patients in the ipss risk category intermediate-2. This medication can also help patients with other blood disorders like refractory anemias and ipss high risk."

Answered by AI

Is recruitment still underway for subjects of this research?

"This study is not currently enrolling patients. The listing for this clinical trial was first posted on September 29th, 2004 and updated most recently on June 28th, 2022. Other active trials studying primary myelofibrosis and Decitabine are presently recruiting; 95 and 106 studies respectively."

Answered by AI

What is the current thinking on Decitabine's efficacy?

"As of now, there are one hundred and six clinical trials involving Decitabine. Out of those, sixteen have progressed to Phase 3 testing. The majority of these studies originated in Philadelphia, but there are 1,529 total locations running active trials for this medication."

Answered by AI

What is the FDA's most recent stance on Decitabine?

"Decitabine is a phase 2 clinical trial medication, meaning that while there is some evidence of its safety, none exists for its efficacy."

Answered by AI

Is this clinical trial widely available in North America?

"Currently, there are 14 sites recruiting patients for this clinical trial. These locations include University of Maryland/Greenebaum Cancer Center in Baltimore, Ingalls Memorial Hospital in Harvey, and Southern Illinois University School of Medicine in South Bend."

Answered by AI

How many guinea pigs are they letting in on this one?

"Unfortunately, this trial is not currently admitting patients. The study was originally posted on September 29th, 2004 and was last updated on June 28th, 2022. However, there are many other ongoing trials that might be a good fit - for example, there are 95 trials related to primary myelofibrosis and 106 Decitabine studies recruiting patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Decitabine in Treating Patients With Myelofibrosis

2004. "Decitabine in Treating Patients With Myelofibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00095784.

All > Fibrosis > Myelofibrosis