Peripheral T Cell LymphomaPhase 2NCT02753543
Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma
A Phase 2 study testing Chidamide in people with Peripheral T Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- Chidamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Nov 2019
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathologically verified peripheral T-cell lymphoma, partial response or stable disease after 3 cycles of CEOP (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or CEOP(cyclophosphamide,vincristin,epirubicin and prednisone)/IVE (ifosfamide, epirubicin, etoposide)/GDP(Gemcitabine, Cis-platinum, Dexamethasone)
- Age ≧16 years, ≦75 years
- ECOG (Eastern Cooperative Oncology Group) =0,1,2
- No previous history of malignancy
- Radiologically measurable disease
- Life expectancy>6 months
- Informed consented
Who cannot join
- Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
- Lab at enrollment(unless caused by lymphoma)
- Neutrophile<1.5*10^9/L
- Platelet<75*10^9/L
- Hemoglobulin<90g/L
- ALT(alanine aminotransferase) or AST (aspartate aminotransferase ) >2*ULN,AKP(alkaline phosphatase) or bilirubin >1.5*ULN (upper limit of normal )
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- Creatinine>1.5*ULN
- Other uncontrollable medical condition that may that may interfere the participation of the study
- Not able to comply to the protocol for mental or other unknown reasons
- Pregnant or lactation
- HIV infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200023
Weili Zhao, MD, PhD, 64370045 ext. 610707, zhao.weili@yahoo.com
Pengpeng Xu, MD, 64370045 ext. 610707, xpproc@msn.com
About this study
Official title: A Multi-center, Prospective, Single-arm, Open Label Phase II Study of Chidamide Combined With Chemotherapy in the Treatment of Peripheral T Cell Lymphoma
This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- Chidamide
- 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.
ChidamideDrug
| Study group | Role | What they receive |
|---|---|---|
| Chidamide plus previous chemotherapy | Experimental | Chidamide 20mg/d Biw p.o. on d1,4,8,11 for of each cycle for 3 cycles Receives: Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response
Measured: 21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)
Secondary outcomes (3)
Progression free survival
Measured: 1 year
Overall survival
Measured: 1 year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: Each cycle of treatment and then every 3 months for 1 year（each cycle is 21 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (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 Ruijin 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753543
- Sponsor's protocol ID
- RJ-PTCL-2016-01
- Status last verified
- Nov 2017
- First submitted
- 19 Apr 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Single-arm, Open Label Phase II Study of Chidamide Combined With Chemotherapy in the Treatment of Peripheral T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02753543
- Acronym / sponsor ID
- RJ-PTCL-2016-01
- Conditions
- Peripheral T Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 28 Apr 2016 (estimated)
- 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, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.
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 previous chemotherapy | Experimental | Drug: ChidamideChidamide 20mg/d Biw p.o. on d1,4,8,11 for of each cycle for 3 cycles |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically verified peripheral T-cell lymphoma, partial response or stable disease after 3 cycles of CEOP (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or CEOP(cyclophosphamide,vincristin,epirubicin and prednisone)/IVE (ifosfamide, epirubicin, etoposide)/GDP(Gemcitabine, Cis-platinum, Dexamethasone)
- Age ≧16 years, ≦75 years
- ECOG (Eastern Cooperative Oncology Group) =0,1,2
- No previous history of malignancy
- Radiologically measurable disease
Key exclusion criteria (11 listed)
- Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
- Lab at enrollment(unless caused by lymphoma)
- Other uncontrollable medical condition that may that may interfere the participation of the study
- Pregnant or lactation
- HIV infection
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 |
|---|---|---|
| Chidamide | Drug | Chidamide plus previous chemotherapy |
Primary outcome
complete response
Time frame: 21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)
3 secondary outcomes
Progression free survival
Time frame: 1 year
Overall survival
Time frame: 1 year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: Each cycle of treatment and then every 3 months for 1 year（each cycle is 21 days）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- 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 Chidamide in people with Peripheral T Cell Lymphoma, run by Ruijin 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 7 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 14 Nov 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 Weili Zhao, MD, PhD (64370045 ext. 610707, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (time frame: 21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days)). 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 14 Nov 2017.