PRECISE LBCL: Precision Treatment Readiness Through Comprehensive Genomic Sequencing in 1st Line LBCL

NCT07829445 — Not yet recruiting, 60 participants, M.D. Anderson Cancer Center

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RegistryNCT07829445
StatusNot yet recruiting
Study typeObservational
Enrollment60 (Estimated)
SponsorM.D. Anderson Cancer Center (Other)
ConditionsLBCL, Comprehensive Genomic, Precision Treatment
InterventionsStandard of Care (SOC) (Other)
Datesstart 2027-02-25 (estimated), primary completion 2027-06-30 (estimated), completion 2029-06-30 (estimated), first posted 2026-09-21, last updated 2026-09-21
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for LBCL All trials for Comprehensive Genomic All trials of Standard of Care (SOC)

-Summary

To determine whether special laboratory tests, called genomic sequencing, can identify specific subtypes of LBCL and provide information that may help guide treatment decisions.

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+Detailed description

Primary Objectives

• To determine the proportion of patients whose BostonGene Tumor Portrait Molecular Test results are available to the treating physician by the start of Cycle 2 of standard-ofcare anthracycline-based therapy

+Arms and interventions

ArmTypeInterventionsDescription
ABC_SubtypeOther: Standard of Care (SOC)
DZsig_SubtypeOther: Standard of Care (SOC)
Other GCB_SubtypeOther: Standard of Care (SOC)
  • Standard of Care (SOC) (Other): Standard of care

+Outcome measures

Primary outcomes

  • Safety and adverse events (AEs) [Through study completion; an average of 1 year.]: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

+Eligibility

Sex: All, ages: 18 Years to any

Eligibility Criteria

* Age ≥18y
* Pathology-confirmed diffuse large B-cell lymphoma, not otherwise specified or high-grade B-cell lymphoma (HGBL) who are eligible for standard-of-care, full-dose 6 cycles of anthracycline-based treatment
* Stage 3 or 4 disease by Lugano Criteria
* Available biopsy sample for BostonGene Tumor Portrait™ test ( for sample preparation)

Exclusion Criteria

* Known central nervous system (CNS) disease (cases concerning for CNS involvement should be evaluated with MRI and lumbar puncture)
* Any baseline characteristics that in the opinion of the treating physician would preclude patients from receiving standard-of-care anthracycline-based treatment
* Participation (or planning to participate) in any therapeutic clinical trials for lymphoma during the planned treatment course. Note, patients who become eligible for other studies based on inadequate response, toxicity to therapy, or other reasons that arise after the initiation of standard therapy on this study are permitted to pursue those alternative trials as appropriate. Participation in other non-therapeutic and/or observational studies are permitted.

+Locations (1)

FacilityCityCountryStatus
UT MD Anderson Cancer CenterHouston, TexasUnited States

+Investigators