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Diffuse Large B Cell Lymphoma (DLBCL)Phase 2NCT06748521

Dynamic CtDNA-guided Targeted Therapy in DLBCL

A Phase 2 study testing R-CHOP + X in people with Diffuse Large B Cell Lymphoma (DLBCL), run by Ruijin Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diffuse Large B Cell Lymphoma (DLBCL)
What is being tested?
R-CHOP + X
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
No sites listed yet
Study dates
31 Dec 2024to 1 Jun 2028
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Weili Zhao, MD, PhD contact

+862164370045 ext. 610707

zhao.weili@yahoo.com

About this study

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

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.

Being tested
R-CHOP + X
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.

  • R-CHOP + XDrug

    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.

Study groups in NCT06748521
Study groupRoleWhat they receive
treatment groupExperimentalNot described
Receives: Drug: R-CHOP + X

What is being measured

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

  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.

    Measured: End of Cycle 6 (each cycle is 21 days)

Secondary outcomes (3)

  1. 2-year progression-free survival (PFS) rate

    PFS, defined as the time from enrollment to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator. The 2-year PFS rate was the percentage of patients who did not experience disease progression or death within two years of enrollment.

    Measured: 2 years

  2. 2-year Overall survival (OS) rate

    OS defined as the time from enrollment to death from any cause. The 2-year OS rate was the percentage of patients who did not die within two years of enrollment.

    Measured: 2 years

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

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: From enrollment to study completion, a maximum of 4 years

Timeline

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

  1. First posted27 Dec 2024
  2. Study start31 Dec 2024 (estimated)
  3. Primary completion13 Dec 2026 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06748521
Sponsor's protocol ID
2023ZD0511200
Status last verified
Dec 2024
First submitted
12 Dec 2024
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing R-CHOP + X in people with Diffuse Large B Cell Lymphoma (DLBCL), run by Ruijin Hospital.

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 6 inclusion and 19 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 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Weili Zhao, MD, PhD (+862164370045 ext. 610707, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR) rate (time frame: End of Cycle 6 (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 NCT06748521.

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 27 Dec 2024.

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