Relapsed or Refractory DLBCLPhase 2PCRNCT05115409
Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen in Relapsed or Refractory DLBCL (PCR)
A Phase 2 study testing Anti-PD-1 Antibody Plus Chidamide and Rituximab in people with Relapsed or Refractory DLBCL, run by Sun Yat-sen University.
Trial summary
To assess the efficacy and safety of Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen in the Treatment of Relapsed or Refractory DLBCL Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Relapsed or Refractory DLBCL
- What is being tested?
- Anti-PD-1 Antibody Plus Chidamide and Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients: 60-75 years old.
- Relapsed or Refractory patients
- Histologically confirmed DLBCL with CD20 positive
- ECOG physical condition score: 0-1 points for patients.
- The patients must be with at least one evaluable or measurable lesion meeting LYRIC 2016 criteria.
- Patients who had received at least 2 cycles of standard first-line rituximab regimens didn't obtain remission or relapsed after remission, or who were unable or unwilling to receive chemotherapy due to illness or severe chemotherapy toxicity.
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- Hematology values must be within the following limits at baseline:
- Absolute neutrophil count (ANC) ≥1,500 cells/μL. In case bone marrow involvement, ANC≥1,000 cells/μL.
- Platelets≥75,000 cells/μL. In case bone marrow involvement, platelets≥50,000 cells/μL
- Hemoglobin≥90 g/L.In case bone marrow involvement, hemoglobin≥70 g/L
- Biochemical values must be within the following limits at baseline:
- Alanine aminotransferase#ALT#≤2.5×upper limit of normal (ULN).
- Aspartate aminotransferase (AST) ≤2.5×ULN
- Total bilirubin≤1.5×ULN, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin.
- Serum creatinine ≤2×ULN.
- LVEF ≥50%, as determined by echocardiography.
- Each subject (or their legally acceptable representative) must sigh an informed consent form (ICF) indicating that he or she understands the purpose of any procedures for the study and are willing to participate in the study.
- Thyroid stimulating hormone (TSH) or free Thyroxine (FT4) or free Triiodothyronine (FT3) were within the normal range of ±10%.
- Expected survival time ≥6 months.
- No radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before medication.
Who cannot join
- Patients with clinically symptomatic CNS metastases (e.g., cerebral edema, need for hormonal intervention, or progression of BRAIN metastases) and/or cancerous meningitis.
- A history of severe allergies or allergic reactions to drugs mentioned above.
- Patients with other malignant tumors have undergone radical treatment, except for basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of breast and carcinoma in situ of cervix.
- History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome.
- Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA titer (no more than 2500 copies/mL or 1000 IU/mL) andHCV RNA (no more than the lower limit of the detection method) in the row. In addition to active hepatitis B or hepatitis C infections requiring treatment, group trials can be conducted. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 2500 copies/mL or 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group.
- Inability to swallow, intestinal obstruction, or other factors that affect drug administration and absorption.
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- Received systemic antineoplastic therapy within 28 days before treatment, including chemotherapy, immunotherapy, biotherapy (cancer vaccine, cytokines, or growth factors that control cancer), etc..
- Received major surgery within 28 days before treatment or radiotherapy within 90 days before treatment.
- Received live vaccination (except influenza attenuated vaccine) within 28 days before treatment.
- Patients requiring long-term systemic glucocorticoid therapy or other immunosuppressive therapy. Allowing subjects to use local, ocular, intra-articular, intranasal and inhaled glucocorticoid therapy.
- Patients suffering from uncontrollable comorbid diseases, including but not limited to symptomatic congestive heart failure, uncontrollable hypertension, unstable angina, active peptic ulcer or bleeding disorders.
- Pregnant or lactating women.
- Patients with a history of interstitial lung disease or non-infectious pneumonia. Subjects who have previously had drug-induced or radioactive non-infectious pneumonia but asymptomatic are allowed to enroll.
- Any life-threatening disease, physical condition or organ dysfunction according to the researchers' judgment may endanger the safety of the subject or put the clinical research at excessive risk.
- Any other conditinons that the investigator considers inappropriate for participation in this study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen for the Relapsed or Refractory Diffuse Large B Cell Lymphoma (PCR): a Prospective, Multicenter, Single-Arm, Phase II Trial
To assess the efficacy and safety of Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen in the Treatment of Relapsed or Refractory DLBCL
- Conditions
- Relapsed or Refractory DLBCL
- Being tested
- Anti-PD-1 Antibody Plus Chidamide and Rituximab
- Keywords
- DLBCL, Rituximab, Chidamide, Anti-PD-1 Antibody
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD-1 Antibody Plus Chidamide and RituximabDrug
Anti-PD-1 Antibody 200mg, ivd, D1, every 3 weeks Chidamide 30mg, po,D-1, 4, 8, 11, 15, 18, every 3 weeks Rituximab 375mg/m2, ivd, D1, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen in Relapsed or Refractory DLBCL | Experimental | Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen in Relapsed or Refractory DLBCL Receives: Drug: Anti-PD-1 Antibody Plus Chidamide and Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate
Measured: 24 weeks
Objective remission rate
Measured: 24 weeks
Disease Control Rate
Measured: 24 weeks
Partial Remission Rate
Measured: 24 weeks
Secondary outcomes (3)
Progression-free Survival
PFS was defined as time from study registration to first disease progression or death whichever occurred first, otherwise subject data were censored at time last known disease free
Measured: 2 years
Overall Survival
OS was defined as time from study registration to death, and otherwise censored at time last known alive
Measured: 2 years
Percentage of Participants With Adverse Events (AEs)
Number of participants with adverse events occurring up to 30 days after the last administration are evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.01
Measured: Up to 30 days after the last cycle of per-protocol treatment and 90 days after last dose of anti-PD-1 antibody
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Jun 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory DLBCLStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Chipscreen Biosciences, Ltd.
- Responsible party
- Principal investigator, Huiqiang Huang, Sun Yat-sen University
- Investigators
- Huiqiang Huang, professor, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115409
- Sponsor's protocol ID
- RR-DLBCL-PCR
- Acronym
- PCR
- Status last verified
- Apr 2022
- First submitted
- 9 Nov 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen for the Relapsed or Refractory Diffuse Large B Cell Lymphoma (PCR): a Prospective, Multicenter, Single-Arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT05115409
- Acronym / sponsor ID
- PCR / RR-DLBCL-PCR
- Conditions
- Relapsed or Refractory DLBCL
- Keywords
- DLBCL, Rituximab, Chidamide, Anti-PD-1 Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Chipscreen Biosciences, Ltd.
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Nov 2021 (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.
To assess the efficacy and safety of Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen in the Treatment of Relapsed or Refractory DLBCL
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen in Relapsed or Refractory DLBCL | Experimental | Drug: Anti-PD-1 Antibody Plus Chidamide and RituximabAnti-PD-1 Antibody Plus Chidamide and Rituximab Regimen in Relapsed or Refractory DLBCL |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male or female patients: 60-75 years old.
- Relapsed or Refractory patients
- Histologically confirmed DLBCL with CD20 positive
- ECOG physical condition score: 0-1 points for patients.
- The patients must be with at least one evaluable or measurable lesion meeting LYRIC 2016 criteria.
Key exclusion criteria (15 listed)
- Patients with clinically symptomatic CNS metastases (e.g., cerebral edema, need for hormonal intervention, or progression of BRAIN metastases) and/or cancerous meningitis.
- A history of severe allergies or allergic reactions to drugs mentioned above.
- Patients with other malignant tumors have undergone radical treatment, except for basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of breast and carcinoma in situ of cervix.
- History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome.
- Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA titer (no more than 2500 copies/mL or 1000 IU/mL) andHCV RNA (no more than the lower limit of the detection method) in the row. In addition to active hepatitis B or hepatitis C infections requiring treatment, group trials can be conducted. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 2500 copies/mL or 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group.
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 |
|---|---|---|
| Anti-PD-1 Antibody Plus Chidamide and RituximabAnti-PD-1 Antibody 200mg, ivd, D1, every 3 weeks Chidamide 30mg, po,D-1, 4, 8, 11, 15, 18, every 3 weeks Rituximab 375mg/m2, ivd, D1, every 3 weeks | Drug | Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen in Relapsed or Refractory DLBCL |
Primary outcome
complete response rate
Time frame: 24 weeks
Objective remission rate
Time frame: 24 weeks
Disease Control Rate
Time frame: 24 weeks
Partial Remission Rate
Time frame: 24 weeks
3 secondary outcomes
Progression-free Survival
Time frame: 2 years
Overall Survival
Time frame: 2 years
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to 30 days after the last cycle of per-protocol treatment and 90 days after last dose of anti-PD-1 antibody
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- 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. This study is not recruiting at the moment.
Huiqiang Huang, professor principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-PD-1 Antibody Plus Chidamide and Rituximab in people with Relapsed or Refractory DLBCL, run by Sun Yat-sen University.
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 20 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huiqiang Huang, professor (0086-13808885154, huanghqsysucc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response rate (time frame: 24 weeks). The study lists 4 primary outcomes in all. 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 7 Apr 2022.