Diffuse Large B-Cell LymphomaPhase 2NCT04023916
Sintilimab Plus R-CHOP as the First-line Treatment in Patients With Diffuse Large B-Cell Lymphoma.
A Phase 2 study testing Sintilimab-R-CHOP in people with Diffuse Large B-Cell Lymphoma and Sintilimab, run by Chinese Academy of Medical Sciences.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Sintilimab and R-CHOP regimen as the first-line treatment for DLBCL patients with TP53 mutation and PD-L1 positive. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma, Sintilimab, TP53 Mutation
- What is being tested?
- Sintilimab-R-CHOP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 30 Jul 2021
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results;
- Age between 18 to 70 years old;
- World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2;
- No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment;
- Life expectancy no less than 6 months;
- The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures;
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- Ann Arbor stage I~ IV
- previously untreated advanced DLBCL.
- At least one bi-dimensionally measurable lesion (greater than [>] 1.5 centimeters in its largest dimension by CT scan or magnetic resonance imaging)
- Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of DLBCL.
- Agree to remain abstinent or use contraceptive measures.
Who cannot join
- History of autologous stem cell transplantation,radiotherapy or chemotherapy.
- History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;
- With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;
- Lymphoma originated in the central nervous system;
- Left ventricular ejection fraction ≦50％;
- Abnormal lab results in enrollment:Neutrophil count: <1.5*10^9/L；Platelet count <75*10^9/L；AST or ALT >2 times the upper limit of normal level，AKP and total bilirubin >1.5 times the upper limit of normal level;serum creatinine >1.5 times the upper limit of normal level;
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- Other uncontrolled medical conditions which the investigators think might influence the results of the trial;
- Patients with mental illnesses or other diseases that might not comply with the trial plan;
- Women during pregnancy or lactation;
- HIV positive patients;
- HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase II Study of Sintilimab Plus R-CHOP as the First-line Treatment for DLBCL Patients With TP53 Mutation and PD-L1 Positive.
The purpose of this study is to evaluate the efficacy and safety of Sintilimab and R-CHOP regimen as the first-line treatment for DLBCL patients with TP53 mutation and PD-L1 positive.
Read the detailed description
This Phase II, open-label, single-center, non-randomized study will evaluate the safety and efficacy of induction treatment consisting of Sintilimab in combination with Rituximab plus chemotherapy (R-CHOP) as the first-line treatment in participants with DLBCL, followed by consolidation treatment with Sintilimab alone in patients who achieve CR at the end of induction.For safety reasons, the initial enrollment of the first 6 patients in the study will be slow and conduct intensive monitoring for safety. If the dose-limited toxicity event was observed in more than 2 of the first 6 patients and was assessed caused by cumulative exposure to the study drug combination therapy, the trial will be stopped.This study also aim to evaluate the correlation of clinical efficacy to the expression of PD-L1,PD-1,CD3,CD4,CD8,CD56,CD58,β2-MG，HLA-DR/DP/DQ and so on by immunohistochemical techniques.
- Conditions
- Diffuse Large B-Cell Lymphoma, Sintilimab, TP53 Mutation
- Being tested
- Sintilimab-R-CHOP
- Keywords
- DLBCL, Sintilimab, R-CHOP, TP53, PD-L1
- 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.
Sintilimab-R-CHOPDrug
Drug:Sintilimab:
Sintilimab:200 mg IV on Day 1 Cycles 2-8, during induction treatment, followed by 200 mg IV on Day 1 of Cycles 9-14.
Drug: Rituximab Rituximab:Participants with previously untreated DLBCL will receive rituximab at a dose of 375 mg/m^2 IV on Day 1 of Cycle 1-8, during induction treatment.
Drug: Cyclophosphamide Cyclophosphamide will be administered at a dose of 750 mg/m^2 IV on Day 2 of Cycle 1-6, during induction treatment.
Drug: Doxorubicin Hydrochloride Liposome Injection Doxorubicin Hydrochloride Liposome Injection will be administered at a dose of 35 mg/m^2 IV on Day 2-3 of Cycle 1-6, during induction treatment.
Drug: Vincristine Vincristine will be administered at a dose of 1.4 mg/m^2 (maximum 2 mg) IV on Day 2 of Cycle 1-6, during induction treatment.
Drug: Prednisone Prednisone will be administered at a dose of 40 mg/m^2 orally on Days 1-5 of Cycle 1-6, during induction treatment. Prednisolone may be given if prednisone is unavailable.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab-R-CHOP | Experimental | Participants with previously untreated DLBCL will receive rituximab and CHOP during Cycle 1 (21-day cycle) and Sintilimab, rituximab, and CHOP during Cycles 2-6 (21-day cycle) ,Sintilimab and rituximab during Cycles 6-8 (21-day cycle) , followed by Sintilimab from Cycles 9-14 (8-week cycle) during consolidation treatment. Receives: Drug: Sintilimab-R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
complete remission rate after treated by Sintilimab+ R-CHOP regimen.
Measured: every 3 months until 30 months after the last patient's enrollment.
Secondary outcomes (2)
overall survival
from the date of inclusion to date of death, irrespective of cause
Measured: 30 months after the last patient's enrollment
adverse events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.For safety reasons, the initial enrollment of the first 6 patients in the study will be slow and conduct intensive monitoring for safety. the monitoring time window for each patient is 21 days after the first treatment. If the dose-limited toxicity event was observed in more than 2 of the first 6 patients and was assessed by the research team as caused by cumulative exposure to the study drug combination therapy, the trial will be stopped.
Measured: from the date of first cycle of treatment to 30 months after last patient's enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Dec 2019 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Yuankai, Chinese Academy of Medical Sciences
- Investigators
- Yuankai Shi, M.D, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023916
- Sponsor's protocol ID
- NCC2066
- Status last verified
- Dec 2019
- First submitted
- 16 Jul 2019
- Last updated
- 11 Dec 2019
- Results posted
- 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 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Sintilimab Plus R-CHOP as the First-line Treatment for DLBCL Patients With TP53 Mutation and PD-L1 Positive.
- ClinicalTrials.gov ID
- NCT04023916
- Acronym / sponsor ID
- NCC2066
- Conditions
- Diffuse Large B-Cell Lymphoma, Sintilimab, TP53 Mutation
- Keywords
- DLBCL, Sintilimab, R-CHOP, TP53, PD-L1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 18 Jul 2019 (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.
The purpose of this study is to evaluate the efficacy and safety of Sintilimab and R-CHOP regimen as the first-line treatment for DLBCL patients with TP53 mutation and PD-L1 positive.
Detailed description
This Phase II, open-label, single-center, non-randomized study will evaluate the safety and efficacy of induction treatment consisting of Sintilimab in combination with Rituximab plus chemotherapy (R-CHOP) as the first-line treatment in participants with DLBCL, followed by consolidation treatment with Sintilimab alone in patients who achieve CR at the end of induction.For safety reasons, the initial enrollment of the first 6 patients in the study will be slow and conduct intensive monitoring for safety. If the dose-limited toxicity event was observed in more than 2 of the first 6 patients and was assessed caused by cumulative exposure to the study drug combination therapy, the trial will be stopped.This study also aim to evaluate the correlation of clinical efficacy to the expression of PD-L1,PD-1,CD3,CD4,CD8,CD56,CD58,β2-MG，HLA-DR/DP/DQ and so on by immunohistochemical techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab-R-CHOP | Experimental | Drug: Sintilimab-R-CHOPParticipants with previously untreated DLBCL will receive rituximab and CHOP during Cycle 1 (21-day cycle) and Sintilimab, rituximab, and CHOP during Cycles 2-6 (21-day cycle) ,Sintilimab and rituximab during Cycles 6-8 (21-day cycle) , followed by Sintilimab from Cycles 9-14 (8-week cycle) during consolidation treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results;
- Age between 18 to 70 years old;
- World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2;
- No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment;
- Life expectancy no less than 6 months;
Key exclusion criteria (11 listed)
- History of autologous stem cell transplantation,radiotherapy or chemotherapy.
- History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;
- With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;
- Lymphoma originated in the central nervous system;
- Left ventricular ejection fraction ≦50％;
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 |
|---|---|---|
| Sintilimab-R-CHOPDrug:Sintilimab: Sintilimab:200 mg IV on Day 1 Cycles 2-8, during induction treatment, followed by 200 mg IV on Day 1 of Cycles 9-14. Drug: Rituximab Rituximab:Participants with previously untreated DLBCL will receive rituximab at a dose of 375 mg/m^2 IV on Day 1 of Cycle 1-8, during induction treatment. Drug: Cyclophosphamide Cyclophosphamide will be administered at a dose of 750 mg/m^2 IV on Day 2 of Cycle 1-6, during induction treatment. Drug: Doxorubicin Hydrochloride Liposome Injection Doxorubicin Hydrochloride Liposome Injection will be administered at a dose of 35 mg/m^2 IV on Day 2-3 of Cycle 1-6, during induction treatment. Drug: Vincristine Vincristine will be administered at a dose of 1.4 mg/m^2 (maximum 2 mg) IV on Day 2 of Cycle 1-6, during induction treatment. Drug: Prednisone Prednisone will be administered at a dose of 40 mg/m^2 orally on Days 1-5 of Cycle 1-6, during induction treatment. Prednisolone may be given if prednisone is unavailable. | Drug | Sintilimab-R-CHOP |
Primary outcome
complete remission rate
Time frame: every 3 months until 30 months after the last patient's enrollment.
complete remission rate after treated by Sintilimab+ R-CHOP regimen.
2 secondary outcomes
overall survival
Time frame: 30 months after the last patient's enrollment
adverse events
Time frame: from the date of first cycle of treatment to 30 months after last patient's enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- 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.
Yuankai Shi, M.D principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab-R-CHOP in people with Diffuse Large B-Cell Lymphoma and Sintilimab, run by Chinese Academy of Medical Sciences.
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 11 inclusion and 11 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 11 Dec 2019. 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 Yuankai Shi, M.D (86 010-87788293, syuankaipumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission rate (time frame: every 3 months until 30 months after the last patient's enrollment.). 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 11 Dec 2019.