LBCLNCT07829445
PRECISE LBCL: Precision Treatment Readiness Through Comprehensive Genomic Sequencing in 1st Line LBCL
An observational study of LBCL and Comprehensive Genomic, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LBCL, Comprehensive Genomic, Precision Treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2027to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MD Anderson Cancer Center
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson Cancer Center
Houston, Texas, 77030
Dai Chihara, MD, 713-563-4354, JMDennison@mdanderson.org
Dai Chihara, MD
About this study
To determine whether special laboratory tests, called genomic sequencing, can identify specific subtypes of LBCL and provide information that may help guide treatment decisions.
Read the 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
- Conditions
- LBCL, Comprehensive Genomic, Precision Treatment
- Being tested
- Standard of Care (SOC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC)Other
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| ABC_Subtype | Not described Receives: Other: Standard of Care (SOC) | |
| DZsig_Subtype | Not described Receives: Other: Standard of Care (SOC) | |
| Other GCB_Subtype | Not described Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start25 Feb 2027 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LBCLStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dai Chihara, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829445
- Sponsor's protocol ID
- 2025-1674
- Other IDs
- NCI-2026-06976
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECISE LBCL: Precision Treatment Readiness Through Comprehensive Genomic Sequencing in 1st Line LBCL
- ClinicalTrials.gov ID
- NCT07829445
- Acronym / sponsor ID
- 2025-1674
- Conditions
- LBCL, Comprehensive Genomic, Precision Treatment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 25 Feb 2027 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether special laboratory tests, called genomic sequencing, can identify specific subtypes of LBCL and provide information that may help guide treatment decisions.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABC_Subtype | – | Other: Standard of Care (SOC) |
| DZsig_Subtype | – | Other: Standard of Care (SOC) |
| Other GCB_Subtype | – | Other: Standard of Care (SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care (SOC)Standard of care | Other | ABC_Subtype, DZsig_Subtype, Other GCB_Subtype |
Primary outcome
Safety and adverse events (AEs)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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CAR-T ceLL for Eradication of Active Residual Disease in LBCL (CLEAR-1 Study)
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RecruitingPhase 2
Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial.
B-cell Lymphoma
Not yet recruitingPhase 2
Prizloncabtagene Autoleucel (Prizlon-cel) for the Treatment of Relapsed or Refractory Large B-cell Lymphoma Post FDA Approved CAR T-cell Therapy
Large B Cell Lymphoma, LBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dai Chihara, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of LBCL and Comprehensive Genomic, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dai Chihara, MD (713-563-4354, JMDennison@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.