Peripheral T-cell LymphomaPhase 2NCT03321890
Chidamide Combined With PECM in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
A Phase 2 study testing Chidamide, prednisone and Cyclophosphamide in people with Peripheral T-cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
To observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide, etoposide and methotrexate in relapsed or refractory PTCL. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Chidamide, prednisone and Cyclophosphamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2017to 31 Dec 2020
- 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
- Histopathologically confirmed peripheral T-cell lymphoma (PTCL) patients;
- Patients who have had at least one systemic treatment (including chemotherapy, hematopoietic stem cell transplantation, etc.) who have not remission or relapsed after remission;
- For various reasons can not be hematopoietic stem cell transplantation in patients;
- The age of 18-75 years old, male, female open;
- ECOG (Eastern Cooperative Oncology Group) physical scoring 0-1 points;
- Absolute value of neutrophil≥1.5 × 109 / L, platelet≥90 × 109 / L, hemoglobin≥90g / L;
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- The expected survival time ≥ 3 months;
- No radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation were performed within 4 weeks prior to enrollment.
- Voluntary signature of written informed consent.
Who cannot join
- Pregnancy, breastfeeding women and unwilling to take contraceptive measures of reproductive age patients;
- B-mode ultrasonography showed that the width of end-diastolic pericardial dark area was ≥10mm;
- Patients receiving organ transplants;
- Patients receiving symptomatic treatment of pre-bone marrow toxicity within 7 days prior to enrollment;
- Patients with active bleeding;
- Liver function abnormalities (total bilirubin> 1.5 times the upper limit of normal, ALT( alanine aminotransferase) / AST (Aspartate aminotransferase)> 2.5 times the upper limit of normal or hepatic involvement of ALT / AST> 5 times the upper limit of normal), renal dysfunction Creatinine> 1.5 times the upper limit of normal), electrolyte abnormalities;
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- Persons with mental disabilities / those who can not obtain informed consent;
- Patients with drug abuse and long-term alcohol abuse that may affect the evaluation of test results;
- The investigators determined that they were not fit to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology,Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhiming Li, DM, +86-13719189172, Lizhm@sysucc.org.cn
Yu Wang, DM, 86-20-87343765, Wangyu@sysucc.org.cn
About this study
Official title: A Multicenter, Single-arm, Open II Phase Clinical Trial Evaluating the Efficacy of Chidamide Combined With Prednisone, Cyclophosphamide, Etoposide, and Methotrexate (PECM) in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
To observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide, etoposide and methotrexate in relapsed or refractory PTCL.
Read the detailed description
Prednisone, cyclophosphamide, etoposide, and methotrexate regimens are derived from a "metronidazole, etoposide, procarbazine and cyclophosphamide (PEPC) regimen" regimen that differs from the traditional "maximal Tolerance "chemotherapy, and the use of low-dose chemotherapy, frequent drug therapy, the purpose is to anti-angiogenesis and reduce drug resistance. At present, the program in our treatment of relapsed or refractory PTCL patients effective, safe and controllable, but also look forward to other joint treatment, so as to achieve better curative effect. To provide new treatment options for such patients.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Chidamide, prednisone, Cyclophosphamide, etoposide, Methotrexate
- Keywords
- relapsed or refractory, peripheral T-cell lymphoma, Combination therapy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Oral, each taking 30 mg (6 tablets), medication twice a week, 30 minutes after breakfast
prednisoneDrug
oral, 20mg / day,after breakfast
CyclophosphamideDrug
oral, 50mg / day,after lunch
etoposideDrug
oral, 50mg / day,after dinner
MethotrexateDrug
oral, 10mg / times, once a week,after breakfast
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy regimen | Experimental | Chidamide + prednisone+cyclophosphamide+etoposide+methotrexate Receives: Drug: Chidamide; Drug: prednisone; Drug: Cyclophosphamide; Drug: etoposide; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
the total proportion of patients with complete response（CR or CRu）and partial response（PR）
Measured: every 8 weeks until 2 years after last patient's enrollment
Secondary outcomes (3)
Duration of response
Duration of complete response（CR or CRu）and partial response（PR）
Measured: every 8 weeks until 2 years after last patient's enrollment
Progress Free Survival(PFS)
Time from treatment until disease progression or death
Measured: 2 years
Overall Survival
Time from treatment until death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start7 Mar 2017
- Primary completion1 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhiming, Sun Yat-sen University
- Investigators
- Wenqi Jiang, MD, Principal investigator, Department of Medical Oncology,Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321890
- Sponsor's protocol ID
- 2016-FXY-079-内科
- Status last verified
- Oct 2017
- First submitted
- 18 Feb 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Open II Phase Clinical Trial Evaluating the Efficacy of Chidamide Combined With Prednisone, Cyclophosphamide, Etoposide, and Methotrexate (PECM) in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT03321890
- Acronym / sponsor ID
- 2016-FXY-079-内科
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- relapsed or refractory, peripheral T-cell lymphoma, Combination therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 Oct 2017 (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 observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide, etoposide and methotrexate in relapsed or refractory PTCL.
Detailed description
Prednisone, cyclophosphamide, etoposide, and methotrexate regimens are derived from a "metronidazole, etoposide, procarbazine and cyclophosphamide (PEPC) regimen" regimen that differs from the traditional "maximal Tolerance "chemotherapy, and the use of low-dose chemotherapy, frequent drug therapy, the purpose is to anti-angiogenesis and reduce drug resistance. At present, the program in our treatment of relapsed or refractory PTCL patients effective, safe and controllable, but also look forward to other joint treatment, so as to achieve better curative effect. To provide new treatment options for such patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination therapy regimen | Experimental | Drug: Chidamide, Drug: prednisone, Drug: Cyclophosphamide, Drug: etoposide, Drug: MethotrexateChidamide + prednisone+cyclophosphamide+etoposide+methotrexate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histopathologically confirmed peripheral T-cell lymphoma (PTCL) patients;
- Patients who have had at least one systemic treatment (including chemotherapy, hematopoietic stem cell transplantation, etc.) who have not remission or relapsed after remission;
- For various reasons can not be hematopoietic stem cell transplantation in patients;
- The age of 18-75 years old, male, female open;
- ECOG (Eastern Cooperative Oncology Group) physical scoring 0-1 points;
Key exclusion criteria (9 listed)
- Pregnancy, breastfeeding women and unwilling to take contraceptive measures of reproductive age patients;
- B-mode ultrasonography showed that the width of end-diastolic pericardial dark area was ≥10mm;
- Patients receiving organ transplants;
- Patients receiving symptomatic treatment of pre-bone marrow toxicity within 7 days prior to enrollment;
- Patients with active bleeding;
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 |
|---|---|---|
| ChidamideOral, each taking 30 mg (6 tablets), medication twice a week, 30 minutes after breakfast | Drug | Combination therapy regimen |
| prednisoneoral, 20mg / day,after breakfast | Drug | Combination therapy regimen |
| Cyclophosphamideoral, 50mg / day,after lunch | Drug | Combination therapy regimen |
| etoposideoral, 50mg / day,after dinner | Drug | Combination therapy regimen |
| Methotrexateoral, 10mg / times, once a week,after breakfast | Drug | Combination therapy regimen |
Primary outcome
Objective response rate
Time frame: every 8 weeks until 2 years after last patient's enrollment
the total proportion of patients with complete response（CR or CRu）and partial response（PR）
3 secondary outcomes
Duration of response
Time frame: every 8 weeks until 2 years after last patient's enrollment
Progress Free Survival(PFS)
Time frame: 2 years
Overall Survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Wenqi Jiang, MD principal investigator
Department of Medical Oncology,Sun Yat-Sen 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 Chidamide, prednisone and Cyclophosphamide in people with Peripheral T-cell Lymphoma, run by Sun Yat-sen 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 9 inclusion and 9 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 26 Oct 2017. 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 Zhiming Li, MD (86-20-87343765, lizhm@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: every 8 weeks until 2 years after 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 26 Oct 2017.