Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)Phase 2NCT03245905
Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-NHL
A Phase 2 study testing Chidamide in people with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL), run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
- 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
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2017to 31 Dec 2021
- 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
- Diagnosed as B-cell Non-Hodgkin's Lymphoma (NHL) according to "2008 WHO classification of tumors of haematopoietic and lymphoid tissues", including Diffuse Large B-Cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), transformed indolent lymphoma (TL), and other subtypes that investigators consider to be appropriate to be enrolled;
- Patients achieved CR or PR in previous cytotoxic chemotherapy, and relapsed later than 6 months after remission;
- Patients with DLBCL, FL grade3, MALT, LPL and SLL received at least two chemotherapy regimens, and Patients with FL grade1-2 received at least three chemotherapy regimens;
- At least one measurable lesion with a longest diameter >1.5cm or a short axis >1.0cm;
- Age18-75 years;
- ECOG performance status 0-2;
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- Life expectancy no less than 3 months;
- Functions within 7 days prior to enrollment: Blood routine test: Hb ≥ 80g/L, absolute neutrophil count ≥1.5 × 109/L, platelet ≥60 × 109/L; Total bilirubin ≤ 1.5 times of normal maximum, ALT/AST≤ 2.5 times of normal maximum, for patients with liver metastasis ALT/AST≤ 5 times of normal maximum; serum creatinin≤1.5 times of normal maximum or CCr≥ 60ml/min;
- LVEF ≥ 50% by echocardiography;
- Contraception during and 4 weeks after the study for patients at child bearing age;
- Patients have signed the Informed Consent Form.
Who cannot join
- Patients received Chidamide treatment within 6 months prior to enrollment;
- Patients with Burkitt Lymphoma, B-lymphoblastic lymphoma, central nervous system lymphoma and HIV-Associated Lymphoma;
- Patients with a "currently active" second malignancy;
- Patients not recovered from non-hematologic toxicities within 4 weeks prior to enrollment due to chemotherapy, radiation and immunotherapy;
- Patients receiving or received corticosteroids within 2 weeks prior to enrollment;
- Patients with cumulative life time dose of Doxorubicin > 450mg/m2;
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- Patients who have been treated with any investigational drug within 4 weeks prior to enrollment;
- Women during pregnancy or lactation;
- Patients with active infection, medical conditions, or mental disorders;
- Patients with active infection of HBV, HCV or HIV;
- Congestive heart failure (NYHA grade III/IV), myocardial infarction within 6 months, QTc elongation with clinical significance (≥480ms), hypertension BP≥150/100 mmHg and symptomatic coronary heart disease that require treatment;
- Patients with drug abuse, long term alcoholism that may impact the results of the trial;
- Non-appropriate patients for the trial according to the judgment of the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong, 510060
HuiQiang Huang, 86-020-87343350, huanghq@sysucc.org.cn
About this study
Official title: Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
Read the detailed description
Patients with relapsed /refractory aggressive B cell lymphoma usually have a poor prognosis. These patients cannot be treated successfully or tolered with the conventional chemotherapy. Epigenetic changes in B-cell lymphoma. Thus, epigenetic agents may offer potential improvment of clinical outcomes. Chidamide is a new type of oral histone deacetylase inhibitor. Our exploratory research found that Chidamide was effect in some relapsed /refractory B cell lymphoma patients
. Thus, we will evaluate the efficacy and safety of Chidamide in the patients with aggressive relapsed refractory B cell lymphoma failed from second line chemotherapy.
- Being tested
- Chidamide
- Medical subject headings
- Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Also called epidaza
Chidamide 30mg orally BIW. Treatment cycles are repeated every 3 weeks.The maximum duration of treatment is 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide | Experimental | Chidamide should be given at a fixed time with fixed dosage Receives: Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate（ORR）
Overall response was determined on the basis of investigator assessments according to lymphoma response to immunomodulatory therapy criteria (LYRIC) for Malignant Lymphoma, 2016. Tumor assessments were performed with CT/MRI with or without PET.
Measured: every 6 weeks until 2 years after last patient's enrollment
Secondary outcomes (3)
progression-free survival（PFS）
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
Measured: every 6 weeks until 2 years after last patient's enrollment
overall survival（OS）
Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason
Measured: every 6 weeks until 2 years after last patient's enrollment
Percentage of Participants With Adverse Events (AEs)
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: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start20 Aug 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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 B-cell Non-Hodgkin's Lymphoma (NHL)Studies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiqiang Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245905
- Sponsor's protocol ID
- CSIIT-B09
- Status last verified
- Mar 2021
- First submitted
- 8 Aug 2017
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT03245905
- Acronym / sponsor ID
- CSIIT-B09
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 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 is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
Detailed description
Patients with relapsed /refractory aggressive B cell lymphoma usually have a poor prognosis. These patients cannot be treated successfully or tolered with the conventional chemotherapy. Epigenetic changes in B-cell lymphoma. Thus, epigenetic agents may offer potential improvment of clinical outcomes. Chidamide is a new type of oral histone deacetylase inhibitor. Our exploratory research found that Chidamide was effect in some relapsed /refractory B cell lymphoma patients
. Thus, we will evaluate the efficacy and safety of Chidamide in the patients with aggressive relapsed refractory B cell lymphoma failed from second line chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide | Experimental | Drug: ChidamideChidamide should be given at a fixed time with fixed dosage |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosed as B-cell Non-Hodgkin's Lymphoma (NHL) according to "2008 WHO classification of tumors of haematopoietic and lymphoid tissues", including Diffuse Large B-Cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), transformed indolent lymphoma (TL), and other subtypes that investigators consider to be appropriate to be enrolled;
- Patients achieved CR or PR in previous cytotoxic chemotherapy, and relapsed later than 6 months after remission;
- Patients with DLBCL, FL grade3, MALT, LPL and SLL received at least two chemotherapy regimens, and Patients with FL grade1-2 received at least three chemotherapy regimens;
- At least one measurable lesion with a longest diameter >1.5cm or a short axis >1.0cm;
- Age18-75 years;
Key exclusion criteria (13 listed)
- Patients received Chidamide treatment within 6 months prior to enrollment;
- Patients with Burkitt Lymphoma, B-lymphoblastic lymphoma, central nervous system lymphoma and HIV-Associated Lymphoma;
- Patients with a "currently active" second malignancy;
- Patients not recovered from non-hematologic toxicities within 4 weeks prior to enrollment due to chemotherapy, radiation and immunotherapy;
- Patients receiving or received corticosteroids within 2 weeks prior to enrollment;
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: epidazaChidamide 30mg orally BIW. Treatment cycles are repeated every 3 weeks.The maximum duration of treatment is 2 years. | Drug | Chidamide |
Primary outcome
objective response rate（ORR）
Time frame: every 6 weeks until 2 years after last patient's enrollment
Overall response was determined on the basis of investigator assessments according to lymphoma response to immunomodulatory therapy criteria (LYRIC) for Malignant Lymphoma, 2016. Tumor assessments were performed with CT/MRI with or without PET.
3 secondary outcomes
progression-free survival（PFS）
Time frame: every 6 weeks until 2 years after last patient's enrollment
overall survival（OS）
Time frame: every 6 weeks until 2 years after last patient's enrollment
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- 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.
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 Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL), 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 11 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 16 Mar 2021. 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 Huiqiang Huang, Professor (+86 020 87343350, huanghq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate（ORR） (time frame: every 6 weeks until 2 years after last patient's enrollment). 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 16 Mar 2021.