Angioimmunoblastic T-cell LymphomaPhase 2NCT05179213
Azacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma
A Phase 2 study testing Azacitidine and Chidamide in people with Angioimmunoblastic T-cell Lymphoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with chidamide in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioimmunoblastic T-cell Lymphoma
- What is being tested?
- Azacitidine and Chidamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 May 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 angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification;
- Age≥18years;
- ECOG≤2;
- Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment;
- Adequate bone marrow hematopoietic function: ANC>1.5 × 109/L，HGB>90g/L，PLT>80 × 109/L;
- Adequate organ function: ALT≤3 times ULN, TBil≤1.5 times ULN, SCr≥50ml/min/m2, cardiac function grade 0-2 (NYHA);
Who cannot join
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
- Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;
- Pregnant or lactating women;
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Azacytidine Combined With Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma: a Multicenter Single Arm Phase II Study
This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with chidamide in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma.
Read the detailed description
Azacytidine was given subcutaneously at a dose of 75 mg/m2 on days 1-7. Chidamide was an oral tablet which was administered 20mg twice weekly. This regimen was repeated every 28 days. Treatment was given until disease progression, unacceptable toxicity, or patient/investigator discretion.
- Conditions
- Angioimmunoblastic T-cell Lymphoma
- Being tested
- Azacitidine, Chidamide
- Keywords
- Angioimmunoblastic T-cell Lymphoma, Azacytidine, 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.
AzacitidineDrug
75 mg/m2 subcutaneously on days 1-7
ChidamideDrug
20mg orally per week continuously
| Study group | Role | What they receive |
|---|---|---|
| Azacytidine combined with chidamide | Experimental | Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days. Receives: Drug: Azacitidine; Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR was defined as the proportion of patients who achieved CR or PR as their best response
Measured: 1year
Secondary outcomes (4)
progression-free survival (PFS)
PFS was defined as time from diagnosis to the date of disease progression or death from any cause or the last follow-up.
Measured: 1 year
Duration of response (DOR)
DOR was defined as the time from the first occurrence of CR or PR to the first diagnosis of PD or relapse.
Measured: through study completion, an average of 1 year
overall survival (OS)
OS was defined as time from diagnosis to death from any cause or the last follow-up.
Measured: through study completion, an average of 2 year
Adverse Events
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: During the whole treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angioimmunoblastic T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Longfu Hospital
- Responsible party
- Sponsor
- Investigators
- Wei Zhang, Dr, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179213
- Sponsor's protocol ID
- PUMCH-NHL-012
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azacytidine Combined With Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma: a Multicenter Single Arm Phase II Study
- ClinicalTrials.gov ID
- NCT05179213
- Acronym / sponsor ID
- PUMCH-NHL-012
- Conditions
- Angioimmunoblastic T-cell Lymphoma
- Keywords
- Angioimmunoblastic T-cell Lymphoma, Azacytidine, Chidamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Longfu Hospital
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 5 Jan 2022 (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 is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with chidamide in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma.
Detailed description
Azacytidine was given subcutaneously at a dose of 75 mg/m2 on days 1-7. Chidamide was an oral tablet which was administered 20mg twice weekly. This regimen was repeated every 28 days. Treatment was given until disease progression, unacceptable toxicity, or patient/investigator discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azacytidine combined with chidamide | Experimental | Drug: Azacitidine, Drug: ChidamidePatients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification;
- Age≥18years;
- ECOG≤2;
- Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment;
- Adequate bone marrow hematopoietic function: ANC>1.5 × 109/L，HGB>90g/L，PLT>80 × 109/L;
Key exclusion criteria (3 listed)
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
- Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;
- Pregnant or lactating women;
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 |
|---|---|---|
| Azacitidine75 mg/m2 subcutaneously on days 1-7 | Drug | Azacytidine combined with chidamide |
| Chidamide20mg orally per week continuously | Drug | Azacytidine combined with chidamide |
Primary outcome
Overall Response Rate (ORR)
Time frame: 1year
ORR was defined as the proportion of patients who achieved CR or PR as their best response
4 secondary outcomes
progression-free survival (PFS)
Time frame: 1 year
Duration of response (DOR)
Time frame: through study completion, an average of 1 year
overall survival (OS)
Time frame: through study completion, an average of 2 year
Adverse Events
Time frame: During the whole treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- 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.
Wei Zhang, Dr study director
Peking Union Medical College 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 Angioimmunoblastic T-cell Lymphoma, run by Peking Union Medical College 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 6 inclusion and 3 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 5 Jan 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 Chong Wei, Dr (+86 13521760705, QH5035@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: 1year). 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 5 Jan 2022.