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NCT03506373 · ClinicalTrials.gov registry record · Phase 2
Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia
A Phase 2 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT03506373: Clinical Trial Phase 2 study, sponsored by Mayo Clinic.
NCT03506373 is a Phase 2 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03506373, a Phase 2 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
This phase II trial studies the side effects of ibrutinib citrate when given with ixazomib, and determines how well they work in treating patients with Waldenstrom macroglobulinemia that is newly diagnosed, has come back (recurrent) or does not respond to treatment (refractory). Enzyme inhibitors, such as ibrutinib and ixazomib citrate, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Complete response rate to be defined as an objective status of CR at any time, where confirmation of the complete response status is required on two consecutive evaluations with a second immunofixation before calling the patient a CR. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Categorized by Response Assessment Criteria as specified in Appendix III of the protocol.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Ibrutinib
- DRUG Ixazomib Citrate
- OTHER Pharmacokinetic Study
- OTHER Pharmacodynamic Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-08-14 |
| Est. Completion | 2026-02-03 |
| Phase | Phase 2 |
Why NCT03506373 stopped before completion
NCT03506373 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03506373 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03506373 about?
NCT03506373 is a clinical study titled "Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia". This phase II trial studies the side effects of ibrutinib citrate when given with ixazomib, and determines how well they work in treating patients with Waldenstrom macroglobulinemia that is newly diagnosed, has come back (recurrent) or does not respond to treatment (refractory). Enzyme inhibitors, s...
What is the current status of trial NCT03506373?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2018-08-14. Estimated completion is 2026-02-03.
What interventions are being tested in trial NCT03506373?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Ibrutinib (DRUG), Ixazomib Citrate (DRUG), Pharmacokinetic Study (OTHER), Pharmacodynamic Study (OTHER).
Who is sponsoring clinical trial NCT03506373?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03506373's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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