Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03225716 · ClinicalTrials.gov registry record · Phase 1
A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT03225716: Clinical Trial Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT03225716 is a Phase 1 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03225716, a Phase 1 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This research study is studying Ulocuplumab combined with ibrutinib as a possible treatment for symptomatic Waldenstrom's Macroglobulinemia (WM).
Primary Outcome
MTD was determined by testing increasing doses up to 1600mg of ulocuplumab on dose escalation levels 1 to 3 with 3 to 7 participants each. MTD reflects the highest dose of ulocuplumab that did not cause a Dose-Limiting Toxicity (DLT) in \>33% of participants. DLTs were defined as any Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) grade 4 or 5 hematologic toxicities (anemia, neutropenia, or thrombocytopenia) and grade 3 or above non-hematologic toxicities. Exceptions were
Interventions
- DRUG Ibrutinib
- DRUG Ulocuplumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-10-20 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 1 |
Why NCT03225716 stopped before completion
NCT03225716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Ibrutinib is the first listed.
NCT03225716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03225716 about?
NCT03225716 is a clinical study titled "A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia". This research study is studying Ulocuplumab combined with ibrutinib as a possible treatment for symptomatic Waldenstrom's Macroglobulinemia (WM).
What is the current status of trial NCT03225716?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2017-10-20. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03225716?
The interventions under investigation include: Ibrutinib (DRUG), Ulocuplumab (DRUG).
Who is sponsoring clinical trial NCT03225716?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03225716's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03125655 · 13 participants
Regulation of Inflammatory Genes in Psoriasis
- NCT03774446 · 13 participants · Phase 2
Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
- NCT03830151 · 13 participants · Phase 1
Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
- NCT04573231 · 13 participants · Phase 2
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI