Peripheral T-cell LymphomaPhase 2NCT04052659
Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in Refractory or Relapsed PTCL
A Phase 2 study testing Sintilimab, Chidamide and Azacidine in people with Peripheral T-cell Lymphoma, run by Peking University at 1 site in China.
Trial summary
This is a single-arm, single-center Phase II clinical trial for patients with relapsed or refractory Peripheral T-cell lymphoma (PTCL). Immunotherapy with anti-PD-1 antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Sintilimab, Chidamide and Azacidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2021to 30 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed PTCL;
- Disease status defined as relapsed or refractory after >=1 prior treatment lines;
- Prior use of HDACi or PD-1/PD-L1 antibodies or demethylation drugs is allowed;
- At least one measurable disease (defined as ≥ 1.5 cm in length-diameter, or 1.1~1.5 cm in length-diameter and >1.0 cm in short-diameter ) ；
- ECOG PS 0~2；
- Provide written informed consent for the trial；
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- 18 ≤ age ≤ 80；
- Life expectancy ≥12 weeks;
- Adequate organ and bone marrow function, laboratory tests should be received within 7 days prior to the use of the research drug and meet the eligibility requirements;
- Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 120 days after the last dose of study medication.
Who cannot join
- Known central nervous system lymphoma or cutaneous T-cell lymphoma;
- Received any immunesuppressive drugs within 4 weeks of the first dose of study medicationy, not including topical corticosteroids or systemic corticosteroids in physiological doses (≤10 mg/day prednisone or equivalent dose of other steroid);
- Patients with active autoimmune diseases requiring systematic treatment in the past two years;
- Received or plan to receive any attenuated vaccines within 4 weeks of the first dose of study medication;
- Received the last anti-tumor therapy within 4 weeks of the first dose of study medication or have not recovered (recovery defined as baseline or ≤ grade 1) from adverse events due to anti-cancer agents;
- Currently participating in an interventional clinical study, unless participating in observational study or during follow-up period of an interventional study;
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- Received any investigational agent within 4 weeks of the first dose of study medication;
- Subjects with interstitial lung disease or lung disease that may interfere with the detection or treatment of suspected drug-related pulmonary toxicity;
- Other primary malignancy;
- Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation;
- Received autologous hemopoietic stem cell transplantation within 90 days of the first dose of study medication;
- Received major surgery or unhealed wound, ulcer or fracture within 4 weeks of the first dose of study medication;
- Active tuberculosis；
- Known primary immunodeficiency；
- Known allergy or hypersensitivity to any monoclonal antibodies or any components used in their preparation;
- Uncontrolled concomitant disease;
- Patients with active hepatitis. 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 50 IU/mL) and HCV RNA (no more than the lower limit of the detection method);
- History of gastrointestinal perforation and /or fistula within 6 months before enrollment;
- Hemophagocytic syndrome；
- Uncontrolled third space effusion, e.g. ascites or pleural effusion cannot be drained or controlled;
- Women who are pregnant or nursing；
- According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions;
- Other researchers consider it unsuitable for patients to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing
Beijing, Beijing Municipality, 100000
Yuqin Song, Dr., 0086 13683398726, songyuqin622@163.com
About this study
Official title: A Study to Evaluate the Efficacy and Safety of Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in the Refractory or Relapsed PTCL: A Phase 2, Single-center, Single-arm, Open Label Trial
This is a single-arm, single-center Phase II clinical trial for patients with relapsed or refractory Peripheral T-cell lymphoma (PTCL). Immunotherapy with anti-PD-1 antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chidamide and azacitidine may respectively stop the growth of tumor cells by blocking histone deacetylation and DNA methylation enzymes needed for cell growth. Giving chidamide and azacitidine with sintilimab these three drugs may work better than single drug or combination of two drugs in treating patients with relapsed or refractory peripheral T-cell lymphoma.
Read the detailed description
PRIMARY OBJECTIVES:
To determine the objective response rate (ORR).
SECONDARY OBJECTIVES:
- To determine the complete response rate (CRR).
- To determine the duration of response (DOR).
- To determine the progression free survival (PFS).
- To determine the overall survival (OS).
- To determine the safety.
EXPLORATORY OBJECTIVES:
Assess the correlation between the expression of PD-L1, CD4, CD8, CD68 in tumor microenvironment and the efficacy of combined therapy in relapsed or refractory peripheral T-cell lymphoma.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Sintilimab, Chidamide, Azacidine
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called IBI308
200 mg IV, every 3 weeks, d1
ChidamideDrug
Also called Epidaza
30 mg PO, 2 times every week, d1 and d4
AzacidineDrug
Also called Ladakamycin
100 mg SC, every 3 weeks, d1 to d7
| Study group | Role | What they receive |
|---|---|---|
| Treatment (sintilimab,chidamide and azacitidine) | Experimental | Sintilimab: 200 mg IV, Q3W, d1
Chidamid: 30 mg PO, BIW, d1, d4
Azacidine: 100 mg SC, Q3W, d1-7 Receives: Drug: Sintilimab; Drug: Chidamide; Drug: Azacidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) by Lugano 2014 up to 24 months
Proportion of subjects who achieve complete response (CR) or partial response (PR) by Lugano 2014 response criteria
Measured: Up to 24 months
Secondary outcomes (5)
Complete remission rate (CRR) by Lugano 2014 up to 24 months
Proportion of subjects who achieve complete response (CR) by Lugano 2014 response criteria
Measured: Up to 24 months
Duration of response (DOR) up to 24 months
DOR is defined as the time from the date of first remission to the date of disease progression or death whichever is earlier
Measured: Up to 24 months
Progression free survival (PFS) up to 24 months
PFS is defined as the time from the treatment date to the date of disease progression per the Lugano 2014 Response Criteria or death regardless of cause
Measured: Up to 24 months
Overall survival (OS) up to 24 months
OS is defined as the time from treatment to the date of death
Measured: Up to 24 months
Incidence and Severity of adverse events by CTCAE v5.0 up to 90 days post-treatment
Incidence and Severity of adverse events as assessed by CTCAE v5.0
Measured: Up to 90 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start15 Apr 2021 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Peking 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhu, Peking University
- Investigators
- Yuqin Song, Doctor, Principal investigator, Cancer Hospital of Beijing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052659
- Sponsor's protocol ID
- CIBI308Y016
- Status last verified
- Mar 2021
- First submitted
- 9 Aug 2019
- Last updated
- 9 Mar 2021
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in the Refractory or Relapsed PTCL: A Phase 2, Single-center, Single-arm, Open Label Trial
- ClinicalTrials.gov ID
- NCT04052659
- Acronym / sponsor ID
- CIBI308Y016
- Conditions
- Peripheral T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 15 Apr 2021 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Aug 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.
This is a single-arm, single-center Phase II clinical trial for patients with relapsed or refractory Peripheral T-cell lymphoma (PTCL). Immunotherapy with anti-PD-1 antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chidamide and azacitidine may respectively stop the growth of tumor cells by blocking histone deacetylation and DNA methylation enzymes needed for cell growth. Giving chidamide and azacitidine with sintilimab these three drugs may work better than single drug or combination of two drugs in treating patients with relapsed or refractory peripheral T-cell lymphoma.
Detailed description
PRIMARY OBJECTIVES:
To determine the objective response rate (ORR).
SECONDARY OBJECTIVES:
- To determine the complete response rate (CRR).
- To determine the duration of response (DOR).
- To determine the progression free survival (PFS).
- To determine the overall survival (OS).
- To determine the safety.
EXPLORATORY OBJECTIVES:
Assess the correlation between the expression of PD-L1, CD4, CD8, CD68 in tumor microenvironment and the efficacy of combined therapy in relapsed or refractory peripheral T-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (sintilimab,chidamide and azacitidine) | Experimental | Drug: Sintilimab, Drug: Chidamide, Drug: AzacidineSintilimab: 200 mg IV, Q3W, d1 Chidamid: 30 mg PO, BIW, d1, d4 Azacidine: 100 mg SC, Q3W, d1-7 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histopathologically confirmed PTCL;
- Disease status defined as relapsed or refractory after >=1 prior treatment lines;
- Prior use of HDACi or PD-1/PD-L1 antibodies or demethylation drugs is allowed;
- At least one measurable disease (defined as ≥ 1.5 cm in length-diameter, or 1.1~1.5 cm in length-diameter and >1.0 cm in short-diameter ) ；
- ECOG PS 0~2；
Key exclusion criteria (23 listed)
- Known central nervous system lymphoma or cutaneous T-cell lymphoma;
- Received any immunesuppressive drugs within 4 weeks of the first dose of study medicationy, not including topical corticosteroids or systemic corticosteroids in physiological doses (≤10 mg/day prednisone or equivalent dose of other steroid);
- Patients with active autoimmune diseases requiring systematic treatment in the past two years;
- Received or plan to receive any attenuated vaccines within 4 weeks of the first dose of study medication;
- Received the last anti-tumor therapy within 4 weeks of the first dose of study medication or have not recovered (recovery defined as baseline or ≤ grade 1) from adverse events due to anti-cancer agents;
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 |
|---|---|---|
| SintilimabAlso: IBI308200 mg IV, every 3 weeks, d1 | Drug | Treatment (sintilimab,chidamide and azacitidine) |
| ChidamideAlso: Epidaza30 mg PO, 2 times every week, d1 and d4 | Drug | Treatment (sintilimab,chidamide and azacitidine) |
| AzacidineAlso: Ladakamycin100 mg SC, every 3 weeks, d1 to d7 | Drug | Treatment (sintilimab,chidamide and azacitidine) |
Primary outcome
Objective response rate (ORR) by Lugano 2014 up to 24 months
Time frame: Up to 24 months
Proportion of subjects who achieve complete response (CR) or partial response (PR) by Lugano 2014 response criteria
5 secondary outcomes
Complete remission rate (CRR) by Lugano 2014 up to 24 months
Time frame: Up to 24 months
Duration of response (DOR) up to 24 months
Time frame: Up to 24 months
Progression free survival (PFS) up to 24 months
Time frame: Up to 24 months
Overall survival (OS) up to 24 months
Time frame: Up to 24 months
Incidence and Severity of adverse events by CTCAE v5.0 up to 90 days post-treatment
Time frame: Up to 90 days post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- 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.
Yuqin Song, Doctor principal investigator
Cancer Hospital of Beijing University
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 Sintilimab, Chidamide and Azacidine in people with Peripheral T-cell Lymphoma, run by Peking University 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 10 inclusion and 23 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 9 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuqin Song, Doctor (010-88196115, songyuqin622@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) by Lugano 2014 up to 24 months (time frame: Up to 24 months). 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 9 Mar 2021.