Angioimmunoblastic T-cell LymphomaPhase 2PETNCT03273452
Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma (PET: Prednisone, Etoposide and Thalidomide)
A Phase 2 study testing Chidamide in people with Angioimmunoblastic T-cell Lymphoma, run by Qingdao University at 1 site in China.
Trial summary
This study aims to investigate the efficacy and safety of PET regimen combined with Chidamide for angioimmunoblastic T cell lymphoma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Angioimmunoblastic T-cell Lymphoma
- What is being tested?
- Chidamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to May 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically diagnosed as angioimmunoblastic T cell lymphoma (diagnosed by pathologic department in IIIA hospitals or verified by certified institutions), immunohistochemistry should include: CD3, CD4, CD8, CD20, CD10, CD21, CD35, Bcl6, CXCL13, EBER, PD-1, Ki67.
- At least on measurable focus (≥1.0*1.0cm by imaging), or at least one evaluable focus;
- Age 18-75 years, both male and female;
- ECOG 0-2, KPS≥ 70points;
- Expected survival ≥3 months;
- Peripheral blood neutrophil count ≥1.5×10^9/L, platelet count≥ 75×10^9/L, Hb≥ 90g/L;
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- Liver function: bilirubin ≤1.5 times of the normal maximum; AST、ALT≤2 times of the normal maximum (for patients with liver infiltration AST、ALT≤3 times of the normal maximum); renal function: blood creatinine ≤2 times the normal maximum;
- Negative random pregnancy test for fertile women patients within 7 days before enrollment;
- No radiation therapy, chemotherapy, targeted therapy nor hemopoietic stem cell transplantation within 4 weeks before enrollment;
- No anti-tumor therapy at enrollment, including herbal therapy, immunotherapy and biologic therapy, symptomatic treatment is not within this range;
Who cannot join
- Women during pregnancy or lactation, and fertile women that are not willing to take contraceptive measurements;
- Patients with other malignant tumors simultaneously that have not been effectively controlled;
- Patients with history of using HDAC inhibitors;
- Patients who are allergic to medicine used in the trial, or have metabolic disorders toward these medicine;
- Patients with severe active infection;
- Patients with HIV or syphilis infection;
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- Patients with prolonged QT interval (male > 450ms，female > 470ms), or chronic heart failure patients with level III or IV cardiac function; or those have the following heart disease within 6 months before enrollment: acute coronary syndrome, acute heart failure (heart function level III or IV), distinctive ventricular arrhythmias (prolonged ventricular tachycardia, ventricular fibrillation, etc);
- Patients with history of organ transplantation;
- Patients with history of thrombosis and embolism;
- Patients with mental disorders or those who are unable to sign a written consent;
- Patients with drug abuse or long-time alcoholism that may influence the result of the trial;
- Patients who do not have capacity of legal transactions;
- Patients currently in other clinical trials;
- Those who are recognized as inappropriate for the trial by the investigators;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Hongwei Xue, MD. PhD, (+86)13475875599, Xuehongwei1867@163.com
About this study
Official title: Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma, a Multicentric, Single Arm, Open Label Phase II Clinical Trial
This study aims to investigate the efficacy and safety of PET regimen combined with Chidamide for angioimmunoblastic T cell lymphoma patients.
Read the detailed description
Patients enrolled in the trial would be given prednisone, etoposide, thalidomide and Chidamide, and the response and side effects are observed and documented.
- Conditions
- Angioimmunoblastic T-cell Lymphoma
- Being tested
- Chidamide
- Medical subject headings
- Immunoblastic Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Also called PCT regimen
Chidamide will be given orally 30mg,biw, along with PET regimen (prednisone 100mg,po,qd,d1-5; etoposide 100mg,po,qd,d1-5; thalidomide 100mg,po,qn,d1-14;)
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | In this group, patients will be given prednisone 100mg,qd,d1-5; etoposide 100mg,qd,d1-5; thalidomide 100mg,qn,d1-14; Chidamide 30mg,biw; Receives: Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective remission rate(ORR)
the rate of patients who achieve objective remission after the treatment,including CR (complete remission),CRu (complete remission with unrecovered platelet count) and PR (partial remission).
Measured: every 3 months until 24 months after the last patient's enrollment
Secondary outcomes (3)
duration of remission
from date of complete remission to date of progression, relapse, or death from any cause
Measured: from the day of remission to the date of first documented progression，up to 24 months after the last patient's enrollment
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 24 months after the last patient's enrollment
overall survival
from the date of inclusion to date of death, irrespective of cause
Measured: 24 months after the 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 posted6 Sep 2017
- Study start1 Mar 2017
- Primary completionFeb 2019 (estimated)
- Study completionMay 2019 (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 Angioimmunoblastic T-cell LymphomaStudies of the same condition, open and under way.
- 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
- Model description
- single arm trial, patients enrolled would be treated in this arm.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Xue, Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273452
- Sponsor's protocol ID
- Xuehw001
- Acronym
- PET
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the trial is finished, all the data would be available at the principle investigator's location.
Publications
Wang Y, Zhang M, Song W, Cai Q, Zhang L, Sun X, Zou L, Zhang H, Wang L, Xue H. Chidamide plus prednisone, etoposide, and thalidomide for untreated angioimmunoblastic T-cell lymphoma in a Chinese population: A multicenter phase II trial. Am J Hematol. 2022 May;97(5):623-629. doi: 10.1002/ajh.26499. Epub 2022 Mar 11.
PubMed 35170082
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma, a Multicentric, Single Arm, Open Label Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT03273452
- Acronym / sponsor ID
- PET / Xuehw001
- Conditions
- Angioimmunoblastic T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 6 Sep 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 aims to investigate the efficacy and safety of PET regimen combined with Chidamide for angioimmunoblastic T cell lymphoma patients.
Detailed description
Patients enrolled in the trial would be given prednisone, etoposide, thalidomide and Chidamide, and the response and side effects are observed and documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm trial, patients enrolled would be treated in this arm.
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: ChidamideIn this group, patients will be given prednisone 100mg,qd,d1-5; etoposide 100mg,qd,d1-5; thalidomide 100mg,qn,d1-14; Chidamide 30mg,biw; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically diagnosed as angioimmunoblastic T cell lymphoma (diagnosed by pathologic department in IIIA hospitals or verified by certified institutions), immunohistochemistry should include: CD3, CD4, CD8, CD20, CD10, CD21, CD35, Bcl6, CXCL13, EBER, PD-1, Ki67.
- At least on measurable focus (≥1.0*1.0cm by imaging), or at least one evaluable focus;
- Age 18-75 years, both male and female;
- ECOG 0-2, KPS≥ 70points;
- Expected survival ≥3 months;
Key exclusion criteria (14 listed)
- Women during pregnancy or lactation, and fertile women that are not willing to take contraceptive measurements;
- Patients with other malignant tumors simultaneously that have not been effectively controlled;
- Patients with history of using HDAC inhibitors;
- Patients who are allergic to medicine used in the trial, or have metabolic disorders toward these medicine;
- Patients with severe active 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 |
|---|---|---|
| ChidamideAlso: PCT regimenChidamide will be given orally 30mg,biw, along with PET regimen (prednisone 100mg,po,qd,d1-5; etoposide 100mg,po,qd,d1-5; thalidomide 100mg,po,qn,d1-14;) | Drug | treatment group |
Primary outcome
Objective remission rate(ORR)
Time frame: every 3 months until 24 months after the last patient's enrollment
the rate of patients who achieve objective remission after the treatment,including CR (complete remission),CRu (complete remission with unrecovered platelet count) and PR (partial remission).
3 secondary outcomes
duration of remission
Time frame: from the day of remission to the date of first documented progression，up to 24 months after the last patient's enrollment
progression free survival
Time frame: from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment
overall survival
Time frame: 24 months after the 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 25 Sep 2017.
- Derived from this study: PubMed 35170082Wang Y, Zhang M, Song W, Cai Q, Zhang L, Sun X, Zou L, Zhang H, Wang L, Xue H. Chidamide plus prednisone, etoposide, and thalidomide for untreated angioimmunoblastic T-cell lymphoma in a Chinese population: A multicenter phase II trial. Am J Hematol. 2022 May;97(5):623-629. doi: 10.1002/ajh.26499. Epub 2022 Mar 11.
- Individual participant dataSharing planned: Yes. After the trial is finished, all the data would be available at the principle investigator's location.
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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 Angioimmunoblastic T-cell Lymphoma, run by Qingdao 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 14 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 25 Sep 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 Hongwei Xue, MD. PhD ((+86)13475875599, Xuehongwei1867@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective remission rate(ORR) (time frame: every 3 months until 24 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 NCT03273452, 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 25 Sep 2017.