A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001) (NCT03162536)
๐ฉบ Plain-English Summary (8th-Grade Level)
This study aims to evaluate the safety, tolerability, pharmacodynamic, and pharmacokinetic (PK) of nemtabrutinib (formerly ARQ 531) tablets in selected participants with relapsed or refractory hematologic malignancies. No formal hypothesis testing will be performed for this study.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (28 items) and avoid the listed exclusions (15 items).
Location: Mayo Clinic Hospital ( Site 0140) โ Scottsdale, Arizona
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria Potential participants who meet ANY of the following exclusion criteria are not eligible for enrollment into this study:
- Had immunotherapy, radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product within 5 half-lives or four weeks (whichever is shorter) prior to treatment initiation, or oral therapy within 5 half-lives or one week (whichever is shorter) prior to treatment initiation
- Transformation of follicular lymphoma (FL) to a more aggressive subtype of lymphoma or grade 3b FL
- Participants currently being treated with the following drugs:
- CYP2C8 substrates with a narrow therapeutic index (such as paclitaxel)
- P-gp substrates with a narrow therapeutic index (such as digoxin)
- CYP3A strong inducers (such as rifampin) Note: A washout period of at least 5 times the half-life after the last dose of any of the above treatments is required for a participant to be eligible for study enrollment
- Active central nervous system (CNS) involvement
- Pregnant or breast-feeding women
- Has significant, ongoing co-morbid conditions which would preclude safe delivery of the study drug
- Uncontrolled illness including but not limited to ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, cardiac infarction in the past six months, and psychiatric illness that would limit compliance with study requirements
- QT corrected (QTc) prolongation (defined as a QTc \> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including 2nd degree atrioventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (10 Sites)
- Mayo Clinic Hospital ( Site 0140) โ Scottsdale, Arizona
- UCLA Hematology & Oncology ( Site 0017) โ Los Angeles, California
- Colorado Blood Cancer Institute ( Site 0225) โ Denver, Colorado
- University of Michigan ( Site 0018) โ Ann Arbor, Michigan
- Mayo Clinic - Rochester ( Site 0138) โ Rochester, Minnesota
- Duke Cancer Center ( Site 0067) โ Durham, North Carolina
- The Ohio State University Wexner Medical Center ( Site 0056) โ Columbus, Ohio
- Tennessee Oncology, PLLC ( Site 0020) โ Nashville, Tennessee
- UT Southwestern Medical Center ( Site 0116) โ Dallas, Texas
- University of Utah, Huntsman Cancer Institute ( Site 0122) โ Salt Lake City, Utah
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.