Relapsed or Refractory Peripheral T-cell LymphomaPhase 2NCT04329130
Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
A Phase 2 study testing Chidamide, Lenalidomide in people with Relapsed or Refractory Peripheral T-cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this open label,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Peripheral T-cell Lymphoma
- What is being tested?
- Chidamide, Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2020to 26 Mar 2025
- 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
- peripheral T cell lymphoma (PTCL);
- no remission or relapse after at least one previous systemic treatment；
- at least one assessable lesion；
- 18-75 years;
- ECOG PS 0-2;
- proper functioning of the major organs;
- expected survival time ≥3 months.
Who cannot join
- previous received treatment of HDAC inhibitor or lenalidomide;
- central nervous system (CNS) involvement;
- serious heart problems;
- known allergies to experimental drug ingredients;
- diagnosed with or receiving treatment for a malignancy other than lymphoma;
- uncontrolled active infection, with the exception of tumor-related b-symptom fever;
- unable or unwilling to receive antithrombotic therapy;
- history of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510000
Wenyu Li, MD
About this study
Official title: Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma: an Open Label, Single Arm, Phase II Study
The purpose of this open label,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma.
Read the detailed description
Histone deacetylase(HDAC) inhibitor has been used in relapsed or refractory peripheral T-cell lymphoma.There are no international studies of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma. Therefore, this study intends to select the oral HDAC inhibitor Chidamide combined with lenalidomide for relapsed or refractory peripheral T-cell lymphoma, and explore its efficacy and safety.
- Being tested
- Chidamide, Lenalidomide
- Medical subject headings
- Recurrence, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide, LenalidomideDrug
All patients enrolled in the study will accept Chidamide combination with lenalidomide regimen.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide combined Lenalidomide | Experimental | Chidamide, 20 mg, twice per week; lenalidomide, 25 mg, d1-21, and rest for 7 days.
one treatment cycle per 28 days.For patients with limited lesions and good drug response, local radiotherapy may be assessed by the investigator. Receives: Drug: Chidamide, Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Overall Response Rate
Measured: 4-years
Secondary outcomes (3)
PFS
Progression Free Survival
Measured: 4-years
DOR
Duration of Overall Response
Measured: 4-years
OS
Overall Survival
Measured: 4-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start27 Mar 2020
- Primary completion26 Mar 2022 (estimated)
- Study completion26 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
- Investigators
- Qingqing Cai, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329130
- Sponsor's protocol ID
- B2020-013
- Status last verified
- Apr 2020
- First submitted
- 28 Mar 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma: an Open Label, Single Arm, Phase II Study
- ClinicalTrials.gov ID
- NCT04329130
- Acronym / sponsor ID
- B2020-013
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 26 Mar 2022 (estimated)
- Study completion
- 26 Mar 2025 (estimated)
- First posted
- 1 Apr 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.
The purpose of this open label,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma.
Detailed description
Histone deacetylase(HDAC) inhibitor has been used in relapsed or refractory peripheral T-cell lymphoma.There are no international studies of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma. Therefore, this study intends to select the oral HDAC inhibitor Chidamide combined with lenalidomide for relapsed or refractory peripheral T-cell lymphoma, and explore its efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide combined Lenalidomide | Experimental | Drug: Chidamide, LenalidomideChidamide, 20 mg, twice per week; lenalidomide, 25 mg, d1-21, and rest for 7 days. one treatment cycle per 28 days.For patients with limited lesions and good drug response, local radiotherapy may be assessed by the investigator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- peripheral T cell lymphoma (PTCL);
- no remission or relapse after at least one previous systemic treatment；
- at least one assessable lesion；
- 18-75 years;
- ECOG PS 0-2;
Key exclusion criteria (8 listed)
- previous received treatment of HDAC inhibitor or lenalidomide;
- central nervous system (CNS) involvement;
- serious heart problems;
- known allergies to experimental drug ingredients;
- diagnosed with or receiving treatment for a malignancy other than lymphoma;
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, LenalidomideAll patients enrolled in the study will accept Chidamide combination with lenalidomide regimen. | Drug | Chidamide combined Lenalidomide |
Primary outcome
ORR
Time frame: 4-years
Overall Response Rate
3 secondary outcomes
PFS
Time frame: 4-years
DOR
Time frame: 4-years
OS
Time frame: 4-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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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.
Qingqing Cai, MD principal investigator
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, Lenalidomide in people with Relapsed or Refractory 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 7 inclusion and 8 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 24 Apr 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?
Contact Qingqing Cai, MD (0086-20-87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 4-years). 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 24 Apr 2020.