Cutaneous T-cell LymphomaPhase 2NCT04296786
Sintilimab Plus Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter Phase II Study
A Phase 2 study testing Sintilimab and Chidamide in people with Cutaneous T-cell Lymphoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of Sintilimab combined with Chidamide in the treatment of relapsed/refractory cutaneous T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cutaneous T-cell Lymphoma
- What is being tested?
- Sintilimab and Chidamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed cutaneous T-cell lymphoma according World Health Organization (WHO) classification.
- ECOG≤2
- Patients with measurable lesions, with or without extra-dermal lesions, clinical stage of IIB-IVB.
- Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment.
- Absolute neutrophil count (ANC）≥0.75×109/L，platelet (PLT) ≥ 50×109/L，hemoglobin (HGB）≥ 80 g/L
- Thyroid stimulating hormone (TSH) within normal range
Who cannot join
- Pre-existing uncontrolled active infection
- Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN), total bilirubin (TBIL) >1.5 times ULN, serum creatinine >1.5 times ULN
- Patients with clinically significant QT interval prolongation (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), acute coronary syndrome (ACS) within 1 year, congestive heart failure (CHF), and symptomatic coronary heart disease.
- Patients who have received organ transplantation or hematopoietic stem cell transplantation.
- Active bleeding or recent thrombotic disease
- Patients with known interstitial lung disease
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- Patients with active autoimmune disease or history of autoimmune disease in the past 2 years
- Patients with CNS involvement
- Pregnant or lactating women
- History of mental illness
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhang Wei, +86 136 8147 3557, vv1223@vip.sina.com
Wei Chong, +86 13521760705, QH5035@163.com
About this study
Official title: Sintilimab Combined With Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter Single Arm Phase II Study
This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of Sintilimab combined with Chidamide in the treatment of relapsed/refractory cutaneous T-cell lymphoma.
Read the detailed description
This is a single-arm phase 2 study with fixed does of combined Sintilimab and Chidamide regimen. This regimen is repeated every 21 days. Sintilimab (200mg) is administered intravenously on day 1 of every cycle. Chidamide is used 20mg twice per week continuously. From the beginning of the trial, sindilimab will be used for 96 weeks, until disease progress, intolerable toxicity or patient/investigator discretion. Patients will continue to receive Chidamide treatment until disease progression, unacceptable toxicity, or patient/investigator discretion.
The response will be evaluated every 2 cycles in the first 36 weeks and every 4 cycles from week 36 till the end of treatment. The patients who achieve complete remission (CR), partial remission (PR), and stable disease (SD) will receive further treatment. The patients with progressed disease (PD) will be continue on the treatment and reassess after 4-8 weeks to rule out false progression. On confirmation of PD , patients will be withdrawn from the trial and receive salvage regimens.
- Conditions
- Cutaneous T-cell Lymphoma
- Being tested
- Sintilimab, Chidamide
- Keywords
- Chidamide, Sintilimab, cutaneous T-cell lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
200mg intravenously on day 1, every 21 days for 1 cycle, 96 weeks for protocol treatment
ChidamideDrug
20mg po per week continuously
| Study group | Role | What they receive |
|---|---|---|
| Chidamide plus Sintilimab | Experimental | Patients in experimental group will receive fixed does of Sintilimab and Chidamide. This regimen is repeated every 21 days. The response will be evaluated every 2 cycles in the first 36 weeks and every 4 cycles from week 36 till the end of treatment. Receives: Drug: Sintilimab; Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR was defined as the proportion of patients who achieved CR or PR as their best response.
Measured: From date of signing the informed consent until the date of first confirmed progression or date of death from any cause, whichever came first, assessed up to 104 weeks
Secondary outcomes (3)
Adverse Events
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: From date of signing the informed consent until the date of first confirmed progression or date of death from any cause, whichever came first, assessed up to 104 weeks
Duration of response (DOR)
DOR was defined as the time from the first occurrence of CR or PR to the first diagnosis of PD or relapse.
Measured: From date of signing the informed consent until the date of first confirmed progression or date of death from any cause, whichever came first, assessed up to 104 weeks
Progression-Free Survival (PFS)
PFS was defined as interval from patient enrollment to the date of disease progression or death from any cause.
Measured: PFS was defined as interval from patient enrollment to the date of disease progression or death from any cause, whichever came first, assessed up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Nov 2019
- 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 Cutaneous T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Beijing Longfu Hospital, Dongzhimen Hospital, Beijing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296786
- Sponsor's protocol ID
- PUMCH-NHL-006
- Status last verified
- Jan 2020
- First submitted
- 3 Mar 2020
- Last updated
- 5 Mar 2020
- 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 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined With Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter Single Arm Phase II Study
- ClinicalTrials.gov ID
- NCT04296786
- Acronym / sponsor ID
- PUMCH-NHL-006
- Conditions
- Cutaneous T-cell Lymphoma
- Keywords
- Chidamide, Sintilimab, cutaneous T-cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Beijing Longfu Hospital, Dongzhimen Hospital, Beijing
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Mar 2020 (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 multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of Sintilimab combined with Chidamide in the treatment of relapsed/refractory cutaneous T-cell lymphoma.
Detailed description
This is a single-arm phase 2 study with fixed does of combined Sintilimab and Chidamide regimen. This regimen is repeated every 21 days. Sintilimab (200mg) is administered intravenously on day 1 of every cycle. Chidamide is used 20mg twice per week continuously. From the beginning of the trial, sindilimab will be used for 96 weeks, until disease progress, intolerable toxicity or patient/investigator discretion. Patients will continue to receive Chidamide treatment until disease progression, unacceptable toxicity, or patient/investigator discretion.
The response will be evaluated every 2 cycles in the first 36 weeks and every 4 cycles from week 36 till the end of treatment. The patients who achieve complete remission (CR), partial remission (PR), and stable disease (SD) will receive further treatment. The patients with progressed disease (PD) will be continue on the treatment and reassess after 4-8 weeks to rule out false progression. On confirmation of PD , patients will be withdrawn from the trial and receive salvage regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide plus Sintilimab | Experimental | Drug: Sintilimab, Drug: ChidamidePatients in experimental group will receive fixed does of Sintilimab and Chidamide. This regimen is repeated every 21 days. The response will be evaluated every 2 cycles in the first 36 weeks and every 4 cycles from week 36 till the end of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed cutaneous T-cell lymphoma according World Health Organization (WHO) classification.
- ECOG≤2
- Patients with measurable lesions, with or without extra-dermal lesions, clinical stage of IIB-IVB.
- Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment.
- Absolute neutrophil count (ANC）≥0.75×109/L，platelet (PLT) ≥ 50×109/L，hemoglobin (HGB）≥ 80 g/L
Key exclusion criteria (10 listed)
- Pre-existing uncontrolled active infection
- Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN), total bilirubin (TBIL) >1.5 times ULN, serum creatinine >1.5 times ULN
- Patients with clinically significant QT interval prolongation (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), acute coronary syndrome (ACS) within 1 year, congestive heart failure (CHF), and symptomatic coronary heart disease.
- Patients who have received organ transplantation or hematopoietic stem cell transplantation.
- Active bleeding or recent thrombotic disease
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 |
|---|---|---|
| Sintilimab200mg intravenously on day 1, every 21 days for 1 cycle, 96 weeks for protocol treatment | Drug | Chidamide plus Sintilimab |
| Chidamide20mg po per week continuously | Drug | Chidamide plus Sintilimab |
Primary outcome
Overall Response Rate (ORR)
Time frame: From date of signing the informed consent until the date of first confirmed progression or date of death from any cause, whichever came first, assessed up to 104 weeks
ORR was defined as the proportion of patients who achieved CR or PR as their best response.
3 secondary outcomes
Adverse Events
Time frame: From date of signing the informed consent until the date of first confirmed progression or date of death from any cause, whichever came first, assessed up to 104 weeks
Duration of response (DOR)
Time frame: From date of signing the informed consent until the date of first confirmed progression or date of death from any cause, whichever came first, assessed up to 104 weeks
Progression-Free Survival (PFS)
Time frame: PFS was defined as interval from patient enrollment to the date of disease progression or death from any cause, whichever came first, assessed up to 104 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- 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.
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 and Chidamide in people with Cutaneous T-cell Lymphoma, run by Peking Union Medical College 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 6 inclusion and 10 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 5 Mar 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: From date of signing the informed consent until the date of first confirmed progression or date of death from any cause, whichever came first, assessed up to 104 weeks). 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 5 Mar 2020.