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DLBCLPhase 2NCT06701357

CR-CHOP+X in Previously Untreated DEL

A Phase 2 study testing CR-CHOP+PD1 inhibitor, CR-CHOP + Orelabrutinib and CR-CHOP + decitabine in people with DLBCL, run by Ruijin Hospital 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, single-arm, open-label phase II clinical trial that evaluates the efficacy and safety of CR-CHOP regimen combined with different targeted drugs based on different molecular subtypes in newly diagnosed DEL patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
DLBCL
What is being tested?
CR-CHOP+PD1 inhibitor, CR-CHOP + Orelabrutinib and CR-CHOP + decitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteChina
Study dates
10 Dec 2024to 1 Dec 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

  • 1. Histologically confirmed diffuse large B-cell lymphoma with CD20 positive;
  • 2. MYC and BCL2 are expressed simultaneously, WHO immunohistochemical standards: MYC≥40%, BCL2 ≥50%;
  • 3. Age ≥ 18 years old, ≦75 years old;
  • 4. ECOG physical status score of 0, 1 or 2;
  • 5. No previous history of malignant tumors; No other tumors occurred simultaneously;
  • 6. Patients judged by the investigator to have a life expectancy of at least 6 months;
  • 7. The patient or his legal representative must provide written informed consent prior to any research special examination or procedure;
  • 8. International prognostic Index (IPI) >1 score.

Who cannot join

  • 1. Have previously received systemic or local treatment including chemotherapy;
  • 2. Previously received autologous stem cell transplantation;
  • 3. Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;
  • 4. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases;
  • 5. Primary central nervous system lymphoma;
  • 6. Left ventricular ejection fraction ≤ 50%;
Show all 12Show fewer
  • 7. Laboratory test values at the time of screening (unless due to lymphoma): A. Neutrophils <1.5*109/L; B. Platelet <75*109/L; C. ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal; D. Creatinine levels higher than 1.5 times the upper limit of normal;
  • 8. Other concurrent and uncontrolled medical conditions that the investigator believes will affect patient participation in the study;
  • 9. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
  • 10. Pregnant or lactating women;
  • 11. People living with HIV;
  • 12. Patients with positive HbsAg test results need to undergo HBV DNA test, and can be enrolled before turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV DNA test should also be performed. If the result is positive, the treatment should also be negative before admission.

Trial locations and contacts

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

Li Wang contact

18917762217

dr_wangli@126.com

China1 site, 1 recruiting

  • No. 197 Ruijin 2nd Road, Huangpu District, Shanghai

    Shanghai, Shanghai Municipality

    Li Wang, 18917762217, dr_wangli@126.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Open-label Phase II Study of Chidamide Plus R-CHOP + X in Previously Untreated Diffuse Large B-cell Lymphoma with Double Expression of MYC and BCL2.

This is a prospective, single-arm, open-label phase II clinical trial that evaluates the efficacy and safety of CR-CHOP regimen combined with different targeted drugs based on different molecular subtypes in newly diagnosed DEL patients.

Read the detailed description

Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of CR-CHOP, followed by stratification of the remaining 5 cycles based on genetic subtypes. C1 plus PD1 inhibitor; C2 and C3 were treated with orelabrutinib. TP53mut plus decitabine. During chemotherapy, routine evaluation was performed after each course of treatment, and an objective comprehensive evaluation of efficacy was performed after 3 courses of treatment. Efficacy evaluation Patients with CR or PR should continue the original treatment, and patients with SD or PD should be recommended second-line salvage treatment. For the first summary evaluation after completion of all treatments, CR patients are placed on chidamide maintenance therapy (2 years recommended unless intolerable toxicity or disease progression occurs).

Conditions
DLBCL
Being tested
CR-CHOP+PD1 inhibitor, CR-CHOP + Orelabrutinib, CR-CHOP + decitabine
Keywords
DLBCL, double-expression, chidamide

What participants receive

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

  • CR-CHOP+PD1 inhibitorDrug

    Rituximab 375 mg/m2 D1； Cyclophosphamide 750mg/m2 D2； Doxorubicin 50mg/m2 D2； Vincristine 1.4 mg/m2 D2； Prednisone 60 mg/m2 D2-6； Chidamide 20mg/d D1,4,8,11； PD1 200mg D1

  • CR-CHOP + OrelabrutinibDrug

    Rituximab 375 mg/m2 D1； Cyclophosphamide 750mg/m2 D2； Doxorubicin 50mg/m2 D2； Vincristine 1.4 mg/m2 D2； Prednisone 60 mg/m2 D2-6； Chidamide 20mg/d D1,4,8,11； Orelabrutinib 150mg/qd D1-21

  • CR-CHOP + decitabineDrug

    Rituximab 375 mg/m2 D1； Cyclophosphamide 750mg/m2 D2； Doxorubicin 50mg/m2 D2； Vincristine 1.4 mg/m2 D2； Prednisone 60 mg/m2 D2-6； Chidamide 20mg/d D1,4,8,11； Decitabine 10mg/m2 D-5 - -1

Study groups in NCT06701357
Study groupRoleWhat they receive
Cluster1 DEL：CR-CHOP+PD1 inhibitorExperimentalParticipants who met the inclusion/exclusion criteria signed informed consent and received 1 course of CR-CHOP, followed by stratification of the remaining 5 cycles based on genetic subtypes. C1 plus PD1 inhibitor.
Receives: Drug: CR-CHOP+PD1 inhibitor
Cluster 2 and 3 DEL：CR-CHOP plus OrelabrutinibExperimentalParticipants who met the inclusion/exclusion criteria signed informed consent and received 1 course of CR-CHOP, followed by stratification of the remaining 5 cycles based on genetic subtypes. C2 and C3 were treated with Orelabrutinib.
Receives: Drug: CR-CHOP + Orelabrutinib
Tp53 mut DEL：CR-CHOP plus DecitabineExperimentalParticipants who met the inclusion/exclusion criteria signed informed consent and received 1 course of CR-CHOP, followed by stratification of the remaining 5 cycles based on genetic subtypes.TP53mut plus decitabine.
Receives: Drug: CR-CHOP + decitabine

What is being measured

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

  1. CRR（Complete response rate）

    CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator

    Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

Secondary outcomes (3)

  1. PFS（Progression-free survival）

    PFS, defined as the time from treatment 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

    Measured: 2-year

  2. OS（Overall survival）

    OS defined as the time from treatment to death from any cause

    Measured: 2-year

  3. ORR（Overall response rate）

    ORR at treatment completion or discontinuation defined as the proportion of participants with partial response (PR) or CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator

    Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

Timeline

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

  1. First posted22 Nov 2024
  2. Study start10 Dec 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06701357
Sponsor's protocol ID
CSIIT-B41
Status last verified
Dec 2024
First submitted
21 Nov 2024
Last updated
30 Dec 2024
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?

A Phase 2 study testing CR-CHOP+PD1 inhibitor, CR-CHOP + Orelabrutinib and CR-CHOP + decitabine in people with DLBCL, run by Ruijin Hospital 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 8 inclusion and 12 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 30 Dec 2024. 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.

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 Li Wang (18917762217, dr_wangli@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CRR（Complete response rate） (time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=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 NCT06701357.

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 30 Dec 2024.

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