Dynamic CtDNA-guided Targeted Therapy in DLBCL

NCT06748521 | Not Yet Recruiting Phase 2

• 1 other identifier: 2023ZD0511200
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (1)

• Complete response (CR) rate

  CR rate at the end of treatment. Defined as the proportion of participants who achieved CR at the end of treatment.

  End of Cycle 6 (each cycle is 21 days)

Secondary Outcomes (3)

• 2-year progression-free survival (PFS) rate

  2 years

• 2-year Overall survival (OS) rate

  2 years

• The incidence and severity of adverse events were determined according to the NCI CTCAE v5.0 rating scale

  From enrollment to study completion, a maximum of 4 years

Study Arms (1)

treatment group

EXPERIMENTAL

Drug: R-CHOP + X

Interventions

R-CHOP + X DRUG

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.

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weili Zhao, MD, PhD

CONTACT

+862164370045; zhao.weili@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director, Hematology Department

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 27, 2024
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 13, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share