Peripheral T-cell LymphomaPhase 2NCT04480125
Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy
A Phase 2 study testing Azacitidine and Chidamide in people with Peripheral T-cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Azacitidine and Chidamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2020to 20 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification
- Treatment naive
- Age ≥ 18 years
- Unfit for converntional chemotherapy meeting criteria as following but not limited to: age ≥75, ECOG >2，ADL<100 or CCI>1.
- Must has measurable lesion in CT or PET-CT prior to treatment
- Expected lifetime ≥ 3 months
- Informed consented
Who cannot join
- Has accepted localized or systemic anti-lymphoma treatment
- Has accepted autologous Stem cell transplantation before
- History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- Primary CNS lymphoma
- Left EF≤ 50%
Show all 13Show fewer
- Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/ L ;Platelet<75*10^9/L; ALT or AST >2*ULN; 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
- Patients with mentally disorders or other reasons unable to fully comply with the study protocol
- Pregnant or lactation
- HIV infection
- HBV-DNA and HCV-RNA undectable.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospital
Shanghai
Weili Zhao, M.D. and Ph.D, 021-64370045, zwl_trial@163.com
About this study
Official title: The Efficacy and Safety of Azacitidine in Combination With Chidamide in the Treatment of Newly Diagnosed Peripheral T-Cell Lymphoma Unfit for Conventional Chemotherapy
This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy.
Read the detailed description
Peripheral T-cell lymphoma (PTCL is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for ~10%. CHOP regimen has been widely used in PTCL patients even with unfavourable prognosis, with 5-year overall survival rate of 38.5%. Elderly patients seldom benefit from conventional CHOP regimen. A study showed that CR rate was only 18.1% in elderly patients (median age of 80 years old, ranging from 56 to 93 years old).
Azacitidine combined with romidepsin has been proved efficient in relasped or refractory PTCL, with CR rate of 55%. This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with Chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Azacitidine, Chidamide
- Keywords
- Peripheral T-cell lymphoma, Targeted therapy, Chemo-free therapy
- 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.
AzacitidineDrug
100mg D1-7
ChidamideDrug
30mg BIW PO
| Study group | Role | What they receive |
|---|---|---|
| Aza+Chida | Experimental | Azacitidine ivgtt D1-7 Chindamide 30mg,PO,twice a week Every 21 days for total 6 courses Receives: Drug: Azacitidine; Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Measured: At the end of Cycle 6 (each cycle is 21 days)
Secondary outcomes (7)
Overall response rate
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Measured: At the end of Cycle 6 (each cycle is 21 days)
Progression free survival
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Measured: Baseline up to data cut-off (up to approximately 4 years)
Overall survival
Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Measured: Baseline up to data cut-off (up to approximately 4 years)
Duration of response
Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.
Measured: Baseline up to data cut-off (up to approximately 4 years)
Treatment related mortality
Percentage of death related with treatment on the basis of investigator assessments
Measured: Baseline up to data cut-off (up to approximately 4 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events
Measured: Baseline up to data cut-off (up to approximately 4 years)
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.
Measured: : Baseline (pre-dose [Hour 0] on Cycle1 Day1), Cycle3 Day 1, end of treatment (up to Month 6), every 3 months 1st year, every 6 months 2nd year, and 12 months thereafter up to data cut-off, up to approximately 4 years (cycle length = 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start20 Jun 2020
- Primary completion20 Jun 2022 (estimated)
- Study completion20 Jun 2024 (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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
- Investigators
- Weili Zhao, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480125
- Sponsor's protocol ID
- RJ-PTCL-2
- Status last verified
- Apr 2022
- First submitted
- 19 Jul 2020
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Azacitidine in Combination With Chidamide in the Treatment of Newly Diagnosed Peripheral T-Cell Lymphoma Unfit for Conventional Chemotherapy
- ClinicalTrials.gov ID
- NCT04480125
- Acronym / sponsor ID
- RJ-PTCL-2
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- Peripheral T-cell lymphoma, Targeted therapy, Chemo-free therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 21 Jul 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.
This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy.
Detailed description
Peripheral T-cell lymphoma (PTCL is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for ~10%. CHOP regimen has been widely used in PTCL patients even with unfavourable prognosis, with 5-year overall survival rate of 38.5%. Elderly patients seldom benefit from conventional CHOP regimen. A study showed that CR rate was only 18.1% in elderly patients (median age of 80 years old, ranging from 56 to 93 years old).
Azacitidine combined with romidepsin has been proved efficient in relasped or refractory PTCL, with CR rate of 55%. This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with Chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aza+Chida | Experimental | Drug: Azacitidine, Drug: ChidamideAzacitidine ivgtt D1-7 Chindamide 30mg,PO,twice a week Every 21 days for total 6 courses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification
- Treatment naive
- Age ≥ 18 years
- Unfit for converntional chemotherapy meeting criteria as following but not limited to: age ≥75, ECOG >2，ADL<100 or CCI>1.
- Must has measurable lesion in CT or PET-CT prior to treatment
Key exclusion criteria (13 listed)
- Has accepted localized or systemic anti-lymphoma treatment
- Has accepted autologous Stem cell transplantation before
- History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- Primary CNS 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 |
|---|---|---|
| Azacitidine100mg D1-7 | Drug | Aza+Chida |
| Chidamide30mg BIW PO | Drug | Aza+Chida |
Primary outcome
Complete response rate
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
7 secondary outcomes
Overall response rate
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Progression free survival
Time frame: Baseline up to data cut-off (up to approximately 4 years)
Overall survival
Time frame: Baseline up to data cut-off (up to approximately 4 years)
Duration of response
Time frame: Baseline up to data cut-off (up to approximately 4 years)
Treatment related mortality
Time frame: Baseline up to data cut-off (up to approximately 4 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE
Time frame: Baseline up to data cut-off (up to approximately 4 years)
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Time frame: : Baseline (pre-dose [Hour 0] on Cycle1 Day1), Cycle3 Day 1, end of treatment (up to Month 6), every 3 months 1st year, every 6 months 2nd year, and 12 months thereafter up to data cut-off, up to approximately 4 years (cycle length = 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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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.
Weili Zhao study chair
Ruijin Hospital
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 Azacitidine and 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 13 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 20 Apr 2022. 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, PhD，MD (+862164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: At the end of Cycle 6 (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 20 Apr 2022.