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Small Molecule

Mavorixafor for Waldenström's Macroglobulinemia

Phase 1
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to end of study (up to approximately 2 years)
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to find the best dose for a future registration trial.

Eligible Conditions
  • Waldenström's Macroglobulinemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to end of study (up to approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to end of study (up to approximately 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC of Ibrutinib
Accumulation Ratio of Ibrutinib
Accumulation Ratio of Mavorixafor
+24 more
Secondary outcome measures
Change From Baseline in Hgb at Over the Time
Major Response Rate
Number of Participants With Adverse Events (AEs)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Mavorixafor and IbrutinibExperimental Treatment2 Interventions
Each participants will initially receive mavorixafor at Dose Level 1 (200 mg QD) in combination with ibrutinib 420 mg. Cohort A will comprise the first 6 participants enrolled in the study that complete at least their first cycle at Dose Level 2 (400 mg QD). Cohort A participants will start at Dose Level 1 and be allowed to dose escalate after the first cycle to Dose Level 2, if no DLTs are observed during the first cycle of each participant. Cohort B will comprise the next 6 participants enrolled into the study that complete at least their 1st cycle at Dose Level 3 (600 mg QD). Cohort B participants will start at Dose Level 1 and be allowed to dose escalate up to Dose Levels 2 and 3. Cohort C will comprise the remainder of participants enrolled up to the total of 18. Cohort C participants will start at Dose Level 1 and be allowed to escalate to 400 and 600 mg after each dose level has been deemed safe by participants from Cohort A and B.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mavorixafor
2020
Completed Phase 1
~20
Ibrutinib
2014
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

X4 PharmaceuticalsLead Sponsor
9 Previous Clinical Trials
346 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4
2020. "A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04274738.
~3 spots leftby Apr 2025
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