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CXCR4 Inhibitor

Mavorixafor for Neutropenia

Phase 1 & 2

Waitlist Available

Research Sponsored by X4 Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Participants who are not on G-CSF must be off for ≥14 days prior to the Baseline visit and have an ANC ≤1000 cells/µL at the Screening visit.

Participant has a history of symptomatic chronic neutropenia confirmed by the Investigator.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 6

Awards & highlights

Study Summary

This trial is to study the effects of mavorixafor on people with chronic neutropenia. Neutrophil cell counts will be monitored after an 8 hour period, and participants will have virtual check-ups for 30 days after receiving a single dose.

Who is the study for?

This trial is for people with chronic neutropenia, including congenital and idiopathic types. Eligible participants must have been diagnosed at least 6 months prior, weigh over 15 kg, can be on or off G-CSF treatment but with specific ANC levels, and agree to use effective contraception. Those with active infections or certain medical conditions are excluded.Check my eligibility

What is being tested?

The study tests mavorixafor's effects on individuals with chronic neutropenia in two parts: Part 1 (Phase 1b) explores how it impacts patients; Part 2 (Phase 2) assesses safety of long-term dosing and its effect on neutropenia after six months.See study design

What are the potential side effects?

While the side effects of mavorixafor will be closely studied during this trial, potential risks may include allergic reactions to the drug or its ingredients, digestive issues from capsule ingestion, and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

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

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I haven't taken G-CSF for 14 days and my white blood cell count is low.

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I have a long-term low white blood cell count that causes symptoms.

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I showed improvement after the first part of the treatment.

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I have been on a stable dose of G-CSF for at least 14 days and my white blood cell count is not above 10,000.

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I have had low white blood cell counts for over 6 months not due to medications, infections, or cancer.

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I weigh at least 15 kilograms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 6 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change From Baseline in ANC to Month 6

Change From Baseline in Absolute Neutrophil Count (ANC) to 8 hours Post-dose On Day 1

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Multiple Doses of Mavorixafor

+1 more

Secondary outcome measures

AUC of ALC (AUCALC)

AUC of AMC (AUCAMC)

AUC of ANC (AUCANC)

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: MavorixaforExperimental Treatment1 Intervention

Part 1: Adult participants and adolescent participants who weigh more than 50 kilograms (kg) will receive mavorixafor 400 milligrams (mg) (4 capsules of 100 mg each), orally once on Day 1. Adolescents weighing less than or equal to 50 kg will receive mavorixafor 200 mg (2 capsules of 100 mg each), orally once on Day 1. Part 2: Eligible participants from Part 1 will receive once daily dosing of mavorixafor for 6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mavorixafor

2020

Completed Phase 1

~20

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

X4 PharmaceuticalsLead Sponsor

9 Previous Clinical Trials

319 Total Patients Enrolled

1 Trials studying Neutropenia

150 Patients Enrolled for Neutropenia

Media Library

Mavorixafor (CXCR4 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04154488 — Phase 1 & 2

Neutropenia Research Study Groups: Mavorixafor

Neutropenia Clinical Trial 2023: Mavorixafor Highlights & Side Effects. Trial Name: NCT04154488 — Phase 1 & 2

Mavorixafor (CXCR4 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04154488 — Phase 1 & 2

Frequently Asked Questions

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

Are there any limitations on where this trial can be accessed?

"The recruitment of participants for this trial is presently happening at 6 sites. These include Seattle, Iowa City and Saint Petersburg as well as 3 other locations in the vicinity. To make participation more accessible to potential patients, it would be best to select a site that requires minimal travel."

Answered by AI

Is there still time to join as a participant in this experiment?

"Yes, based on the information provided by clinicaltrials.gov, this trial is currently recruiting patients to join it. The initiative was initially launched on October 16th 2020 and its details were last modified on November 30th 2022. 50 people are required across 6 different sites."

Answered by AI

How many participants have enrolled in this research project?

"This trial necessitates the recruitment of 50 eligible subjects from two different medical institutions: University of Washington in Seattle, Washington and University of Iowa Hospital and Clinics in Iowa City, Iowa."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Mavorixafor in Participants With Congenital Neutropenia and Chronic Idiopathic Neutropenia Disorders

2020. "A Study of Mavorixafor in Participants With Congenital Neutropenia and Chronic Idiopathic Neutropenia Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04154488.