DLBCLPhase 2NCT06750991
CD-RCHOP in ND DLBCL With a Combination of TP53 Mutation and Del(17p)
A Phase 2 study testing CDR-CHOP in people with DLBCL, run by Ruijin Hospital at 1 site in China.
Trial summary
This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- DLBCL
- What is being tested?
- CDR-CHOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 31 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. Pathologically confirmed a combination of TP53 mutation and del(17p);
- 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%;
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- 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.
- 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.
China1 site
No. 197 Ruijin 2nd Road, Huangpu District, Shanghai
Shanghai, Shanghai Municipality
Li Wang, 18917762217, dr_wangli@126.com
About this study
Official title: A Prospective, Open-label Phase II Study of Chidamide, Decitabine Plus R-CHOP in Previously Untreated Diffuse Large B-cell Lymphoma With a Combination of TP53 Mutation and Del(17p)
This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen.
Read the detailed description
This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen. . Patients who achieve CR will continue with chidamide maintenance therapy (20mg, D1,4,8,11) or opt for autologous hematopoietic stem cell transplantation after completion of induction therapy, with maintenance therapy recommended for at least 1 year (unless intolerable side effects or disease progression occur). Concurrent follow-up assessment (patients will enter the follow-up period described in the time and event table) until the end of the specified follow-up period (total study duration is 3 years) or until the patient meets the exit criteria.
- Conditions
- DLBCL
- Being tested
- CDR-CHOP
- Keywords
- DLBCL, TP53, Chidamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDR-CHOPDrug
Rituximab 375 mg/m2 D1 Cyclophosphamide 750 mg/m2 D2 Doxorubicin 50 mg/m2 D2 Vincristine 1.4 mg/m2 D2 Prednisone 69 mg.m2 D2-6 Chidamide 20 mg/d D1,4,8,11 Decitabine 10 mg/m2 D-5 - -1
| Study group | Role | What they receive |
|---|---|---|
| CDR-CHOP | Experimental | Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen. Receives: Drug: CDR-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 1-year
Secondary outcomes (3)
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]
OS（overall survival）
OS defined as the time from treatment to death from any cause
Measured: 2-year
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.
- First posted27 Dec 2024
- Study start31 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCLStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750991
- Sponsor's protocol ID
- CSIIT-B45
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label Phase II Study of Chidamide, Decitabine Plus R-CHOP in Previously Untreated Diffuse Large B-cell Lymphoma With a Combination of TP53 Mutation and Del(17p)
- ClinicalTrials.gov ID
- NCT06750991
- Acronym / sponsor ID
- CSIIT-B45
- Conditions
- DLBCL
- Keywords
- DLBCL, TP53, Chidamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen.
Detailed description
This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen. . Patients who achieve CR will continue with chidamide maintenance therapy (20mg, D1,4,8,11) or opt for autologous hematopoietic stem cell transplantation after completion of induction therapy, with maintenance therapy recommended for at least 1 year (unless intolerable side effects or disease progression occur). Concurrent follow-up assessment (patients will enter the follow-up period described in the time and event table) until the end of the specified follow-up period (total study duration is 3 years) or until the patient meets the exit criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDR-CHOP | Experimental | Drug: CDR-CHOPParticipants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Histologically confirmed diffuse large B-cell lymphoma with CD20 positive;
- 2. Pathologically confirmed a combination of TP53 mutation and del(17p);
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDR-CHOPRituximab 375 mg/m2 D1 Cyclophosphamide 750 mg/m2 D2 Doxorubicin 50 mg/m2 D2 Vincristine 1.4 mg/m2 D2 Prednisone 69 mg.m2 D2-6 Chidamide 20 mg/d D1,4,8,11 Decitabine 10 mg/m2 D-5 - -1 | Drug | CDR-CHOP |
Primary outcome
PFS（Progression-free survival）
Time frame: 1-year
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
3 secondary outcomes
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]
OS（overall survival）
Time frame: 2-year
ORR（overall response rate）
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CDR-CHOP 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 13 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.
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?
PFS（Progression-free survival） (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.