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Not yet recruiting NCT06748521

Dynamic CtDNA-guided Targeted Therapy in DLBCL

Phase II Interventional Diffuse Large B Cell Lymphoma (DLBCL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: R-CHOP + X.
Who it may be relevant to
Registry conditions: Diffuse Large B Cell Lymphoma (DLBCL). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Dynamic CtDNA-guided Targeted Therapy in Patients with Previously Untreated Diffuse Large B-cell Lymphoma

Overview

This is a prospective, single-arm, noninferiority trial involving patients with previously untreated CD20-positive DLBCL. The aim of this study is to determine the efficacy and safety of treatment stratified based on ctDNA dynamic changes after one cycle of chemotherapy and the targeted therapy based on DLBCL genotype. A total of 108 patients were planned to be enrolled in this trial, and the patients were stratified according to the dynamic changes of ctDNA after one cycle of chemotherapy: the chemotherapy-sensitive group continued the original R-CHOP regimen, and the potential drug resistance group received genotype-guided targeted drug combination. The whole trial included a screening period (day -28 to day -1), a treatment period, and a 2-year follow-up period.

Interventions

  • Drug R-CHOP + X
    Eligible participants will receive 1 cycle of R-CHOP therapy with genotyping and ctDNA testing at C1D14. Chemotherapy sensitive patients with C1D14 ctDNA negative or ctDNA LFC ≥ 2 will continue to receive R-CHOP therapy for up to 6 courses. Potentially resistant patients with C1D14 ctDNA positive and LFC \< 2 were stratified by DLBCL genotyping and treated with cycle 2-6 R-CHOP in combination with obutinib or decitabine or lenalidomide or Chidamide.

Primary outcome measures

  • Complete response (CR) rate [Time frame: End of Cycle 6 (each cycle is 21 days)]
Secondary outcome measures (3)
  • 2-year progression-free survival (PFS) rate [Time frame: 2 years]
  • 2-year Overall survival (OS) rate [Time frame: 2 years]
  • The incidence and severity of adverse events were determined according to the NCI CTCAE v5.0 rating scale [Time frame: From enrollment to study completion, a maximum of 4 years]

Eligibility criteria

Inclusion criteria

  • Signed Informed Consent Form
  • Age 18-75 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
  • Previously untreated participants with CD20-positive DLBCL
  • IPI score 2-5
  • ECOG Performance Status of 0, 1, or 2
  • Life expectancy ≥ 6 months

Exclusion criteria

  • Contraindication to any of the individual components of R-CHOP or Obutinib or Decitabine or Lenalidomide or Chidamide
  • Have received systemic or local treatment including chemotherapy in the past
  • Have received autologous stem cell transplantation in the past
  • Past medical history of other malignant tumors, except basal cell carcinoma of the skin and cervical cancer in situ
  • Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases, severe infectious diseases and other diseases
  • Primary central nervous system lymphoma
  • Left ventricular ejection fraction ≦50%
  • Other concurrent and uncontrolled situation which will affect the patient's medical status based on researchers' decision
  • Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
  • ANC < 1.0 x 10\^9/L
  • PLT < 75 x 10\^9/L
  • Hb < 100g/L
  • Serum AST and ALT ≥ 2.5 x ULN
  • Total bilirubin ≥ 1.5 x ULN
  • Serum creatinine ≥ 1.5 x ULN
  • Psychiatric patients or other patients who are known or suspected to be unable to fully accomplish with the research protocol
  • Pregnant or lactating women
  • Patients with positive HbsAg test results need to undergo HBV-DNA test and can be admitted to the group after turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV-DNA is also required；if the result is positive, patients also need to be treated to become negative before entering the group
  • Patients living with HIV

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06748521 · 2023ZD0511200

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗