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NCT04274738 · ClinicalTrials.gov registry record · Phase 1
A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4
A Phase 1 study of Waldenstrom's Macroglobulinemia, sponsored by X4 Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 5
- Study locations
NCT04274738: Completed Phase 1 study of Waldenstrom's Macroglobulinemia, sponsored by X4 Pharmaceuticals.
NCT04274738 is a Phase 1 study of Waldenstrom's Macroglobulinemia that has completed, run by X4 Pharmaceuticals. The registered enrollment target is 16 participants, below the 160-participant average among 5 other Waldenstrom's Macroglobulinemia trials with a reported enrollment target (90% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04274738, a Phase 1 study of Waldenstrom's Macroglobulinemia, has completed, sponsored by X4 Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 5
- Study locations
Study Summary
The primary objective of the study is to establish a pharmacologically active dose of mavorixafor in combination with ibrutinib based on pooled safety, clinical response, pharmacokinetic (PK) and pharmacodynamic (PD) data to select the recommended dose for a randomized registrations trial.
Conditions Studied
Interventions
- DRUG Ibrutinib
- DRUG Mavorixafor
Study Locations (5)
Massachusetts
- Dana Farber Cancer Institute - Boston
- Mass General Hospital Cancer Center - Boston
Colorado
- Colorado Blood Cancer Institute - Denver
Texas
- MD Anderson Cancer Center - Houston
Other
- University of Athens - Athens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-04-30 |
| Est. Completion | 2022-10-31 |
| Phase | Phase 1 |
What the finished NCT04274738 record still lists
NCT04274738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 160-participant average among 5 other Waldenstrom's Macroglobulinemia trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Waldenstrom's Macroglobulinemia appearing as the primary indexed condition, and to 2 interventions - of which Ibrutinib is the first listed.
NCT04274738 lists 5 locations in 4 states (Massachusetts, Colorado, Texas).
Frequently Asked Questions
What is clinical trial NCT04274738 about?
NCT04274738 is a clinical study titled "A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4". The primary objective of the study is to establish a pharmacologically active dose of mavorixafor in combination with ibrutinib based on pooled safety, clinical response, pharmacokinetic (PK) and pharmacodynamic (PD) data to select the recommended dose for a randomized registrations trial.
What is the current status of trial NCT04274738?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2020-04-30. Estimated completion is 2022-10-31.
What conditions does trial NCT04274738 study?
This clinical trial studies the following conditions: Waldenstrom's Macroglobulinemia.
What interventions are being tested in trial NCT04274738?
The interventions under investigation include: Ibrutinib (DRUG), Mavorixafor (DRUG).
Who is sponsoring clinical trial NCT04274738?
This trial is sponsored by X4 Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04274738 being conducted?
This trial has 5 study locations across Colorado, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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