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Diffuse Large B-Cell LymphomaNCT07070648

Study on Predicting Response to Standard First-Line Treatment in Diffuse Large B-Cell Lymphoma (DLBCL) Patients Using ctDNA Combined With PET

An observational study of Diffuse Large B-Cell Lymphoma and DLBCL, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a prospective, multicenter, multi-cohort study of ctDNA combined with PET for predicting the efficacy of standard first-line therapy for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma, DLBCL
What is being tested?
POLA-R-CHP
How many people
300 participants
Where
1 siteChina
Study dates
9 May 2025to 30 Dec 2027
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: Newly diagnosed diffuse large B - cell lymphoma (DLBCL)

Who may be able to join

  • Age ≥ 18 years old.
  • Previously untreated CD20-positive DLBCL patients, including the following types according to the 2016 WHO classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS) including germinal center B-cell type and activated B-cell type; T-cell/histiocyte-rich large B-cell lymphoma; Epstein - Barr virus-positive DLBCL, NOS; ALK-positive large B-cell lymphoma; HHV8-positive DLBCL, NOS; high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma); high-grade B-cell lymphoma, NOS.
  • Signed informed consent form (ICF).
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2, with an expected survival greater than 12 months.
  • Have at least one measurable two-dimensional lesion determined by clinical examination, CT scan, or MRI: ① lymph nodes > 1.5 cm; ② other non-lymph node lesions ≥ 1.0 cm.
  • Good function of major organs: Hematological function: absolute neutrophil count ≥ 1,000/mm³, platelet count ≥ 75,000/mm³; Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin ≤ 1.5× ULN (for patients with Gilbert syndrome, hilar compressive adenopathy-induced cholestasis, liver involvement or lymphoma-induced biliary obstruction < 5 times ULN); Renal function: creatinine clearance > 30 mL/min, creatinine ≤ 1.5× ULN; Pulmonary function: indoor oxygen saturation ≥ 95%; Cardiac function: no obvious cardiac insufficiency or cardiovascular disease.
  • Fertile patients must be willing to take highly effective contraceptive measures during the study and within 120 days after the last administration of treatment.

Who cannot join

  • Patients planned to receive short-cycle chemotherapy and radiotherapy.
  • Subjects judged by the investigator to have any factors affecting compliance with the protocol, including uncontrollable medical, psychological, family, sociological or geographical conditions; or unwilling or unable to comply with the procedures required in the study protocol.
  • Known human immunodeficiency virus (HIV) infection or positive immunassay.
  • Viral infections that cannot be controlled by antiviral drugs, such as herpesvirus active infection, acute or chronic active hepatitis B, acute or chronic active hepatitis C, etc. (Note: Chronic HBV carriers or inactive HBsAg-positive subjects with HBV-DNA below the detection limit can be enrolled, requiring clinical evaluation, and if appropriate, preventive antiviral treatment is required; HCV antibody-negative subjects can be enrolled, and HCV antibody-positive patients need to be tested for HCV-RNA, and if negative, they can be enrolled).
  • Patients with uncontrolled lymphoma central nervous system infiltration (central nervous system diseases diagnosed at the initial diagnosis are allowed, provided that complete remission of central nervous system diseases is achieved and maintained and there is no central nervous system disease at recurrence).
  • Pregnant or lactating patients.
  • Other concurrent serious diseases or medical conditions that would interfere with participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rong Tao, M.D contact

86-21-64175590

rtao@shca.org.cn

Wenhao Zhang contact

ZWHL98@foxmail.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, China

    Rong Tao, M.D, 8621-64175590, rtao@shca.org.cn

    Wenhao Zhang, ZWHL98@foxmail.com

    Recruiting

Other trials in China

About this study

Official title: Study on Predicting Response to Standard First-Line Treatment in Diffuse Large B-Cell Lymphoma (DLBCL) Patients Using ctDNA Combined With PET: A Prospective, Multicenter, Multicohort Investigation

This is a prospective, multicenter, multi-cohort study of ctDNA combined with PET for predicting the efficacy of standard first-line therapy for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).

Read the detailed description

This multicenter, prospective, multi-cohort clinical study was designed to evaluate the relevance of combined test results for PET / CT and ctDNA and patient survival outcomes in patients with naive DLBCL after 2 cycles of treatment with the standard first-line therapy. The study plans to enroll 80 patients with newly diagnosed, CD20-positive DLBCL who have not received prior systemic therapy. Participants will be stratified into two cohorts based on baseline International Prognostic Index (IPI) scores, receiving either the NMPA-approved R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or the NMPA-approved Pola-R-CHP regimen (polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, prednisone) for 6 cycles. PET/CT imaging will be performed at baseline, Cycle 2 Day 20 (C2D20), and 6 weeks after Cycle 6 Day 21 (C6D21), while whole-blood samples for circulating tumor DNA (ctDNA) analysis will be collected at baseline, Cycle 3 Day 1 (C3D1), and C6D21.The primary endpoint of this study is the association of PET / CT and ctDNA test results with progression-free survival (PFS) after 2 cycles of RCHOP or Pola-R-CHP regimen in treatment-naive patients with diffuse large B cell lymphoma (DLBCL). Secondary endpoints are the correlation between the combination of PET / CT and ctDNA with tumor remission after 2 cycles of RCHOP or Pola-R-CHP in DLBCL patients, association of PET / CT and ctDNA with RCHOP or Pola-R-CHP and assessment of the CR rate, ORR, EFS and safety of real-world RCHOP or Pola-R-CHP regimen in treatment-naive DLBCL patients.

Being tested
POLA-R-CHP
Keywords
Diffuse Large B-Cell Lymphoma, ctDNA, PET-CT
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • POLA-R-CHPDrug

    Pola-R-CHP treatment for 6 cycles (IPI score 2-5)

Study groups in NCT07070648
Study groupRoleWhat they receive
Pola-R-CHP treatment group (IPI score 2-5)Pola-R-CHP treatment group (IPI score 2-5)
Receives: Drug: POLA-R-CHP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between combined PET/CT and ctDNA assessments after 2 cycles of R-CHOP or Pola-R-CHP therapy and progression-free survival (PFS)

    Deauville criteria (PET), Lugano 2014 (response), ctDNA (Percentage reduction in ctDNA concentration by NGS kit) Progression-free survival (PFS): Defined as the period from the first administration of medication until disease progression or death from any cause.

    Measured: Baseline, Day 20 of Cycle 2, and 6 weeks after Cycle 6 completion（each cycle is 21 days）

Secondary outcomes (1)

  1. Correlation between combined PET/CT and ctDNA assessments after 2 cycles of R-CHOP or Pola-R-CHP therapy and tumor response and overall survival (OS) in treatment-naive DLBCL patients

    Real-world evaluation of complete response rate (CRR), overall response rate (ORR), progression-free survival (PFS), event-free survival (EFS), overall survival (OS), and safety profiles of R-CHOP or Pola-R-CHP regimens in treatment-naive diffuse large B-cell lymphoma (DLBCL) patients,ctDNA(positve or negative by NGS kit).

    Measured: Through study completion, an average of 2 year"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2025
  2. Study start9 May 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07070648
Sponsor's protocol ID
SHCA-HEMA-03
Status last verified
Jul 2025
First submitted
24 Jun 2025
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diffuse Large B-Cell Lymphoma and DLBCL, run by Fudan University at 1 site in China.

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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Jul 2025. 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 China. 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 Rong Tao, M.D (86-21-64175590, rtao@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between combined PET/CT and ctDNA assessments after 2 cycles of R-CHOP or Pola-R-CHP therapy and progression-free survival (PFS) (time frame: Baseline, Day 20 of Cycle 2, and 6 weeks after Cycle 6 completion（each cycle is 21 days）). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07070648.

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 17 Jul 2025.

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