B-cell Non-Hodgkin's LymphomaPhase 2NCT03105596
Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
A Phase 2 study testing Chidamide plus DICE Regimen in people with B-cell Non-Hodgkin's Lymphoma, run by Peking University.
Trial summary
This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) 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 65 years
- Conditions the study is for
- B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- Chidamide plus DICE Regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 11 Apr 2017to 30 Sep 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 65 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, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, transformed indolent lymphoma, and other subtypes that investigators consider to be appropriate to be enrolled;
- Patients must have received at least one systemic treatment (including chemotherapy), but did not achieve remission or had relapse after remission;
- At least one measurable lesion;
- Age18-65 years, male or female; ECOG performance status 0-1;
- Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥100 × 109/L, Hb ≥ 90g/L;.
- Life expectancy no less than 3 months;
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- Not received chemotherapy, targeted medicine or stem cell transplantation 4 weeks before enrollment;
- Patients have signed the Informed Consent Form.
- -
Who cannot join
- Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
- QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
- pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
- Patients have undergone organ transplantation;
- Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
- Patients with active hemorrhage.
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- Patients with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
- Patients with active infection, or with continuous fever within 14 days prior to enrollment.
- Patients with active infection of HBV, HCV or HIV;
- Had major organ surgery within 6 weeks prior to enrollment.
- Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum).
- Patients with mental disorders or those do not have the ability to consent.
- Patients with drug abuse, long term alcoholism that may impact the results of the trial.
- Patients who have central nervous system involvements;
- Non-appropriate patients for the trial according to the judgment of the investigators.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of Chidamide Plus DICE Regimen 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 combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
Read the detailed description
Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide combined with DICE in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
- Conditions
- B-cell Non-Hodgkin's Lymphoma
- Being tested
- Chidamide plus DICE Regimen
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide plus DICE RegimenDrug
Chidamide 20mg orally d1, 4, 8, 11, 15, 18; Dexamethasone 10mg，ivg, d1-4; ifosfamide 1g/m2, ivg, d1-4, given over 4 hours; Mesna 0.4g, 0,4,8,12 hours during Ifosfamide transfusion, ivg, d1-4; Cisplatin 25mg/m2, ivg, d1-4; Etoposide 60mg/m2, ivg. d1-4.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide plus DICE regimen | Experimental | Chidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) regimen Receives: Drug: Chidamide plus DICE Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate（ORR）
the total proportion of patients with complete response（CR or CRu）and partial response（PR）
Measured: every 6 weeks until 2 years
Secondary outcomes (3)
progression-free survival（PFS）
Time from treatment until disease progression or death
Measured: 2 years
events-free survival（EFS）
Time from treatment to disease progression, death, or discontinuation of treatment for any reason
Measured: 2 years
overall survival（OS）
Time from treatment until death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start11 Apr 2017 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Peking 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhu, Peking University
- Investigators
- Jun Zhu, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105596
- Sponsor's protocol ID
- Chidamide plus DICE
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Chidamide Plus DICE Regimen for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT03105596
- Acronym / sponsor ID
- Chidamide plus DICE
- Conditions
- B-cell Non-Hodgkin's Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 11 Apr 2017 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 10 Apr 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 combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
Detailed description
Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide combined with DICE in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide plus DICE regimen | Experimental | Drug: Chidamide plus DICE RegimenChidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) regimen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, transformed indolent lymphoma, and other subtypes that investigators consider to be appropriate to be enrolled;
- Patients must have received at least one systemic treatment (including chemotherapy), but did not achieve remission or had relapse after remission;
- At least one measurable lesion;
- Age18-65 years, male or female; ECOG performance status 0-1;
- Without bone marrow involvement. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥100 × 109/L, Hb ≥ 90g/L;.
Key exclusion criteria (16 listed)
- Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
- QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
- pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
- Patients have undergone organ transplantation;
- Patients received symptomatic treatment for bone marrow toxicity within 7 days 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 |
|---|---|---|
| Chidamide plus DICE RegimenChidamide 20mg orally d1, 4, 8, 11, 15, 18; Dexamethasone 10mg，ivg, d1-4; ifosfamide 1g/m2, ivg, d1-4, given over 4 hours; Mesna 0.4g, 0,4,8,12 hours during Ifosfamide transfusion, ivg, d1-4; Cisplatin 25mg/m2, ivg, d1-4; Etoposide 60mg/m2, ivg. d1-4. | Drug | Chidamide plus DICE regimen |
Primary outcome
objective response rate（ORR）
Time frame: every 6 weeks until 2 years
the total proportion of patients with complete response（CR or CRu）and partial response（PR）
3 secondary outcomes
progression-free survival（PFS）
Time frame: 2 years
events-free survival（EFS）
Time frame: 2 years
overall survival（OS）
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Jun Zhu, MD principal investigator
Peking University Cancer Hospital & Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide plus DICE Regimen in people with B-cell Non-Hodgkin's Lymphoma, run by Peking University.
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 9 inclusion and 16 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 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Jun Zhu, MD (+86-10-88196596, zj@bjcancer.org), 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). 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 11 Apr 2017.