NCT06289959

Brief Summary

A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
32mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Feb 2024Jan 2029

First Submitted

Initial submission to the registry

January 25, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

March 4, 2024

Status Verified

March 1, 2024

Enrollment Period

4.9 years

First QC Date

January 25, 2024

Last Update Submit

March 1, 2024

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

cfDNAtherapy

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival（PFS）

    Evaluate the PFS among three groups with different treatment practices for diffuse large B-cell lymphoma (DLBCL) patients.

    From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.

Secondary Outcomes (2)

  • Sensitivity, and specificity of plasma cfDNA in DLBCL patients

    From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.

  • Overall survivals(OS)

    From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.

Study Arms (3)

Group1（Plasma cfDNA-negative patients）

ACTIVE COMPARATOR

Continue to receive monotherapy with rituximab （375mg/m2 q3w）for 2 cycles

Diagnostic Test: cfDNA

Group2（plasma cfDNA-positive patients）

EXPERIMENTAL

Continue monotherapy with rituximab （375mg/m2 q3w）for 2 cycles

Diagnostic Test: cfDNA

Group3（plasma cfDNA-positive patients）

EXPERIMENTAL

Receive the original regimen for 2 cycles（R-CHOP like）

Diagnostic Test: cfDNA

Interventions

cfDNADIAGNOSTIC_TEST

After achieving complete metabolic remission (Lugano response assessment criteria) following 6 cycles of R-CHOP-like chemotherapy, patients undergo plasma cfDNA testing upon enrollment，and the follow-up treatment plans are based on cfDNA results.

Group1（Plasma cfDNA-negative patients）Group2（plasma cfDNA-positive patients）Group3（plasma cfDNA-positive patients）

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years, gender not specified.
  • Newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL) confirmed by histopathological examination. Patients should test positive for plasma cfDNA before treatment (defined as positive for point mutations, CNV, IgH-related fusion, or IG clonal rearrangement) and achieve complete metabolic remission after 6 cycles of R-CHOP chemotherapy (evaluated by Lugano response assessment criteria).
  • Patients for whom the researcher predicts a life expectancy of \>6 months.
  • Signed informed consent form.

You may not qualify if:

  • Patients who have undergone autologous stem cell transplantation.
  • Patients with a history of other malignant tumors, except for basal cell carcinoma of the skin or in situ cervical cancer.
  • Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, and other such conditions;
  • Primary central nervous system lymphoma.
  • Patients with mental illness or others known or suspected to be unable to fully comply with the study protocol.
  • Pregnant or lactating women.
  • HIV-infected individuals.
  • Other concurrent and uncontrolled diseases that researchers believe may affect the medical condition of patients participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Bingzong Li, Professor

    Second Affiliated Hospital of Soochow University

    STUDY CHAIR

Central Study Contacts

Han Zhang, Master

CONTACT

0086-13914064082805294554@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2024

First Posted

March 4, 2024

Study Start

February 25, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

March 4, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)