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Anti-metabolite

Ruxolitinib + Azacytidine for Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm

Phase 2

Recruiting

Led By Naval Daver

Research Sponsored by M.D. Anderson Cancer Center

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 to 2

Patients with a diagnosis of myelodysplastic syndrome/myeloproliferative neoplasm, unclassifiable (MDS/MPN-U) that require therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after completion of study treatment

Awards & highlights

Study Summary

This trial is testing a combination of two drugs to treat patients with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm.

Who is the study for?

This trial is for patients with myelofibrosis or myelodysplastic/myeloproliferative neoplasm who need treatment. Eligible participants include those previously treated and relapsed, or newly diagnosed with intermediate/high risk. They must have an ECOG performance status of 0-2, acceptable organ function tests, and not be pregnant or at risk of pregnancy without taking precautions.Check my eligibility

What is being tested?

The study is testing the combination of ruxolitinib phosphate (which blocks enzymes needed for cancer cell growth) and azacytidine (a chemotherapy drug that kills or stops cancer cells from growing). The goal is to see how well these drugs work together in treating specific blood disorders.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system suppression such as infection risks, liver issues indicated by changes in bilirubin levels, kidney problems reflected by creatinine levels, and blood-related side effects like low platelet counts or neutrophil levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I have been diagnosed with MDS/MPN-U and need treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after completion of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after completion of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after completion of study treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Myeloproliferative disease

Objective response rate (complete remission, partial remission, clinical improvement) in patients with myelofibrosis

Secondary outcome measures

Incidence of adverse events defined as grade 3-4 clinically relevant non-hematologic toxicity or a serious adverse event that is felt to be drug related as assessed by the Common Terminology Criteria for Adverse Events version 4.0

Side effects data

From 2021 Phase 2 trial • 71 Patients • NCT01431209

23%

anemia

13%

Fever

11%

platelet count decreased

neutrophil count decreased

sepsis

lymphocyte count decreased

dyspnea

thromboembolic event

hypercalcemia

hypoxia

fever

hypophosphatemia

Acute kidney injury

sinus tachycardia

respiratory failure

fatigue

lung infection

ileus

hypotension

nausea

Investigations

hypertension

cognitive disturbance

pneumonitis

Hepatobiliary - Other

anorexia

dizziness

abdominal pain

diarrhea

pain in extremity

confusion

creatinine increased

delirium

pleural effusion

upper respiratory infection

vomiting

wound infection

Fall

cardiac disorder, Other

seizure

skin infection

syncope

tumor lysis syndome

Infections and infestiations - Other

Anemia

Musculoskeletal, Other

fracture

gait disturbance

gastric hemorrhage

sore throat

leukemia secondary to oncology chemotherapy

lymphedema

100%

80%

60%

40%

20%

Study treatment Arm

Diffuse Large B-cell Lymphoma (DLBCL)

Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (MDS/MPN patients)Experimental Treatment3 Interventions

Patients with MDS/MPN receive ruxolitinib phosphate and azacytidine as in Arm I.

Group II: Arm I (MF patients)Experimental Treatment3 Interventions

Patients with MF receive ruxolitinib phosphate PO BID on days 1-28. Beginning course 4, patients also receive azacytidine SC or IV for 5 days. Treatment repeats every 28 days for 15 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib Phosphate

2011

Completed Phase 2

~390

Azacitidine

2012

Completed Phase 3

~1440

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,007 Total Patients Enrolled

39 Trials studying Polycythemia Vera

4,048 Patients Enrolled for Polycythemia Vera

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,271 Total Patients Enrolled

10 Trials studying Polycythemia Vera

432 Patients Enrolled for Polycythemia Vera

Naval DaverPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

204 Total Patients Enrolled

Media Library

Azacitidine (Anti-metabolite) Clinical Trial Eligibility Overview. Trial Name: NCT01787487 — Phase 2

Polycythemia Vera Research Study Groups: Arm I (MF patients), Arm II (MDS/MPN patients)

Polycythemia Vera Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT01787487 — Phase 2

Azacitidine (Anti-metabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01787487 — Phase 2

Frequently Asked Questions

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

Has Ruxolitinib Phosphate received FDA approval?

"While there is some data supporting the safety of Ruxolitinib Phosphate, it received a score of 2 because there is no efficacy data at this stage in the clinical trial process."

Answered by AI

What prior data exists for Ruxolitinib Phosphate?

"There are a total of 277 active studies underway for Ruxolitinib Phosphate, with 45 of them in Phase 3. Trial locations for this medication are spread out across 8861 different clinical sites, though many trials are concentrated in Beijing."

Answered by AI

How many individuals are being signed up for this clinical trial?

"That is accurate. According to the clinicaltrials.gov website, this study was last updated on 8/18/2022 and is currently looking for 125 patients from 1 site."

Answered by AI

What conditions does Ruxolitinib Phosphate help ameliorate?

"Ruxolitinib Phosphate is an effective intervention for chemotherapy patients and can also be given to those suffering from refractory anemias, leukemia, myelocytic, acute, polycythemia vera."

Answered by AI