What side effects are associated with this type of intervention?

Common treatments for anemia include intravenous iron isomaltoside, oral iron sulfate, and erythropoiesis-stimulating agents (ESAs). Intravenous iron isomaltoside can cause adverse drug reactions in a smaller proportion of patients compared to oral iron sulfate, with side effects including fatigue reduction and a lower discontinuation rate due to intolerance. Oral iron sulfate is associated with higher rates of gastrointestinal side effects and intolerance. ESAs, used in certain types of anemia, can increase the risk of thrombosis and other adverse events, particularly in patients with higher serum erythropoietin levels.

What prior FDA approvals exist?

The FDA has approved several treatments for anemia, particularly in the context of myeloproliferative disorders and other related conditions. Erythropoiesis-stimulating agents (ESAs) such as epoetin alfa and darbepoetin alfa are commonly used to treat anemia by stimulating red blood cell production. Additionally, lenalidomide has been approved for anemia in patients with myelodysplastic syndromes (MDS) with a deletion 5q cytogenetic abnormality. These treatments aim to improve red blood cell counts and reduce the need for transfusions, similar to the goals of the INCB000928 trial.

What other types of research exist?

Promising novel alternatives to INCB000928 for anemia treatment include lenalidomide combined with epoetin alfa, which has shown efficacy in lower-risk myelodysplastic syndromes (MDS) patients. Additionally, azacitidine combined with epoetin-β has been studied for its potential benefits in MDS patients resistant to erythropoietic stimulating agents. Both therapies are in advanced clinical trial stages and offer potential new options for anemia management.

← Back to Search

Other

INCB000928 + Ruxolitinib for Myelofibrosis (LIMBER Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with MF who are transfusion-dependent or present with symptomatic anemia as defined

Ineligible to receive or have not responded to available therapies for anemia such as ESAs

Must not have

Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib for TGB only, within 5 half-lives or 28 days before the first dose of study treatment

Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately upto 13 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called INCB000928, either alone or with ruxolitinib, to see if it is safe and effective. It targets people with Myelofibrosis who need regular blood transfusions or have severe anemia. The goal is to see if the drug can reduce the need for transfusions and improve anemia symptoms.

Who is the study for?

This trial is for people with myeloproliferative disorders causing anemia who've had prior treatment with JAK inhibitors, are dependent on blood transfusions, and have a life expectancy over 6 months. They must not be pregnant or fathering children and should not have received certain other treatments recently.

What is being tested?

The study tests INCB000928 alone or combined with ruxolitinib to assess safety, how the body processes it (PK/PD), and effectiveness in treating symptomatic anemia in myelofibrosis patients. It includes dose-finding phases to determine the best amount of drug to give.

What are the potential side effects?

While specific side effects aren't listed here, typical ones may include reactions at the infusion site, fatigue, changes in blood counts or chemistry that could affect organ function. The trial aims to identify all possible side effects.

Eligibility Criteria

Inclusion Criteria

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

Select...

I need regular blood transfusions due to my myelofibrosis.

Select...

I cannot take or have not responded to standard anemia treatments.

Select...

I have been on a stable ruxolitinib treatment for 12 weeks and have a certain level of myelofibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't taken any cancer treatments except ruxolitinib for TGB within the last 28 days.

Select...

I have had or am a candidate for a stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately upto 13 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately upto 13 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately upto 13 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of treatment-related adverse events

Secondary study objectives

AUC

AUC0-t

Anemia Response

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Treatment Group C (TGC)Experimental Treatment2 Interventions

INCB000928 will be administered in combination with ruxolitinib.

Group II: Treatment Group B (TGB)Experimental Treatment2 Interventions

INCB000928 will be administered in combination with ruxolitinib.

Group III: Treatment Group A (TGA)Experimental Treatment1 Intervention

INCB000928 will be administered once daily (QD).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCB000928

2021

Completed Phase 2

~70

ruxolitinib

2017

Completed Phase 3

~660

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for anemia include erythropoiesis-stimulating agents (ESAs), hypomethylating agents, and red blood cell (RBC) transfusions. ESAs, such as erythropoietin, stimulate the bone marrow to produce more red blood cells, addressing the root cause of anemia by increasing RBC production. Hypomethylating agents, like azacitidine and decitabine, can improve blood counts by modifying the DNA of bone marrow cells, promoting normal cell growth and differentiation. RBC transfusions provide immediate relief by directly increasing the number of red blood cells in circulation. These treatments are crucial for anemia patients as they help alleviate symptoms like fatigue and weakness, improve quality of life, and, in some cases, address the underlying causes of anemia.

Distinguishing anemia and iron deficiency of heart failure: signal for severity of disease or unmet therapeutic need?