Peripheral T Cell LymphomaCHOPNCT03268889
Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma)
A study testing Chidamide in people with Peripheral T Cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients. Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 39 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 15 Sep 2020
- Phase
- Interventional
- 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
- Pathologically diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2008 classification criteria（NK/T cell lymphoma, ALK positive anaplastic large cell lymphoma and granuloma fungoides excluded）;
- De novo peripheral T cell lymphoma patients;
- Age 18-70 years old;
- ECOG≤2；
- Female patients not in lactation nor pregnancy, and no intention to concept during the study and 12 months thereafter. Male patients agree not to impregnate his partner during the study and 12 months thereafter;
- The patient should have evaluable foci (lymphnodes with diameter≥1.0cm, or evaluable skin foci);
- Willing to sign a written consent.
Who cannot join
- T lymphoblast lymphoma;
- Bone marrow infiltrated with lymphoma cell ≥25%；
- NT/T cell lymphoma;
- Granuloma fungoides;
- Severe impaired liver/ renal function (ALT, Bilirubin or creatinine >3 times the normal maximum);
- Uncontrolled infection;
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- Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA ≥ level 2);
- With other tumors;
- With other condition that cause the patient unable to sign the written consent;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Zhengming Jin, MD, PhD, (+86)512-67781856
About this study
Official title: Chidamide With Cyclophosphamide, Etoposide, Vincristine and Prednisone for de Novo Peripheral T Cell Lymphoma Patients
This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.
Read the detailed description
After enrollment, patients in this study will be given Chidamide, Cyclophosphamide, Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then evaluated.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- Chidamide
- Keywords
- Chidamide, CHOP regimen
- 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
Also called CHOP regimen
Chidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone. Receives: Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission Rate
the rate of patients who achieve complete remission after the treatment
Measured: every 3 months until 30 months after the last patient's enrollment
Secondary outcomes (4)
progression free survival
from date of inclusion to date of progression, relapse, or death from any cause
Measured: from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
duration of remission
from date of complete remission to date of progression, relapse, or death from any cause
Measured: from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
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
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 posted31 Aug 2017
- Study start15 Jun 2017
- Primary completion15 Jun 2020 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhengming Jin, MD,PhD, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268889
- Sponsor's protocol ID
- Jinzm 001
- Acronym
- CHOP
- Status last verified
- Aug 2017
- First submitted
- 30 Aug 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data would be available at the First Affiliated Hospital after the study is finished
Publications
Zong X, Yang Z, Zhou J, Jin Z, Wu D. Clinical trial: Chidamide plus CHOP improve the survival of newly diagnosed angioimmunoblastic T-cell lymphoma. Front Immunol. 2024 Aug 20;15:1430648. doi: 10.3389/fimmu.2024.1430648. eCollection 2024.
PubMed 39229263
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide With Cyclophosphamide, Etoposide, Vincristine and Prednisone for de Novo Peripheral T Cell Lymphoma Patients
- ClinicalTrials.gov ID
- NCT03268889
- Acronym / sponsor ID
- CHOP / Jinzm 001
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- Chidamide, CHOP regimen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 31 Aug 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.
This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.
Detailed description
After enrollment, patients in this study will be given Chidamide, Cyclophosphamide, Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: ChidamideIn this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2008 classification criteria（NK/T cell lymphoma, ALK positive anaplastic large cell lymphoma and granuloma fungoides excluded）;
- De novo peripheral T cell lymphoma patients;
- Age 18-70 years old;
- ECOG≤2；
- Female patients not in lactation nor pregnancy, and no intention to concept during the study and 12 months thereafter. Male patients agree not to impregnate his partner during the study and 12 months thereafter;
Key exclusion criteria (9 listed)
- T lymphoblast lymphoma;
- Bone marrow infiltrated with lymphoma cell ≥25%；
- NT/T cell lymphoma;
- Granuloma fungoides;
- Severe impaired liver/ renal function (ALT, Bilirubin or creatinine >3 times the normal maximum);
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 |
|---|---|---|
| ChidamideAlso: CHOP regimenChidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5. | Drug | treatment group |
Primary outcome
Complete Remission Rate
Time frame: every 3 months until 30 months after the last patient's enrollment
the rate of patients who achieve complete remission after the treatment
4 secondary outcomes
progression free survival
Time frame: from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
duration of remission
Time frame: from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
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 31 Aug 2017.
- Derived from this study: PubMed 39229263Zong X, Yang Z, Zhou J, Jin Z, Wu D. Clinical trial: Chidamide plus CHOP improve the survival of newly diagnosed angioimmunoblastic T-cell lymphoma. Front Immunol. 2024 Aug 20;15:1430648. doi: 10.3389/fimmu.2024.1430648. eCollection 2024.
- Individual participant dataSharing planned: Yes. All the data would be available at the First Affiliated Hospital after the study is finished
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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.
Zhengming Jin, MD,PhD principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chidamide in people with Peripheral T Cell Lymphoma, run by The First Affiliated Hospital of Soochow 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 7 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 31 Aug 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.
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 Zhengming Jin, MD,PhD (（+86）512-65223637, suzhouhematology@163.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?
On the ClinicalTrials.gov record for NCT03268889, which also lists 1 linked publication.
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 31 Aug 2017.