Peripheral T Cell LymphomaPhase 2NCT02856997
Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma
A Phase 2 study testing Chidamide with ICE regimen in people with Peripheral T Cell Lymphoma, run by Yuankai Shi.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Chidamide with ICE regimen in patients with relapsed/refractory Peripheral T Cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- Chidamide with ICE regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Peripheral T Cell Lymphoma (PTCL) verified by histopathology/ cytology, according to WHO 2008 classification criteria, including: adult T cell lymphoma or leukemia (human T cell leukemia virus 1 positive); angioimmunoblastic t cell lymphoma; ALK positive anaplastic large cell lymphoma; ALK negative anaplastic large cell lymphoma; non-specified peripheral T cell lymphoma; extra-nodal NK/T cell lymphoma; bowl disease related T cell lymphoma; hepatosplenic T cell lymphoma; subcutaneous panniculitis-like T cell lymphoma; allergic mycosis fungoides.
- There is at least 1 focus that could be evaluated both by histopathology and cytology (˃1.5cm) according to Cheson criteria.
- The patients should have had at least 1 course of systemic treatment (including chemo-therapy, stem cell transplantation etc), but did not achieve remission or had relapse after remission.
- Age18-75 years, male or female;
- General condition should be ECOG 0-1.
- Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;
Show all 9Show fewer
- Expected survival ≥ 3 months;
- No radiotherapy, chemotherapy, targeted therapy or hemopoietic stem cell transplantation received within 4 weeks prior to enrollment.
- Willing to sign the written consent.
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.
- Patients who have received organ transplantation.
- Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
- Patients with active hemorrhage.
- Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
Show all 12Show fewer
- Patients with active infection, or with continuous fever within 14 days prior to enrollment.
- 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.
- 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: Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma: A Phase II Clinical Trial
The purpose of this study is to evaluate the efficacy and safety of Chidamide with ICE regimen in patients with relapsed/refractory Peripheral T Cell lymphoma.
Read the detailed description
Efficacy of the combined regimen is evaluated primarily by objective remission rate, including complete remission, unverified complete remission and partial remission, also by duration of remission, progression free survival, and overall survival.
Safety is accessed by:
- The type, incidence, severity of incidents related to the use of the regimen.
- Laboratory abnormalities, including the type, incidence, severity, relationship with the use of the regimen.
- Incidence of level 3-4 incidents and laboratory abnormalities.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- Chidamide with ICE regimen
- 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.
Chidamide with ICE regimenDrug
Also called Epidaza，HBI-8000
Chidamide and ICE regimen, dosage described in arm description
| Study group | Role | What they receive |
|---|---|---|
| Chidamide with ICE regimen | Experimental | Drugs:Chidamide and ICE regimen (ifosfamide, Mesna,Carboplatin and etoposide): Chidamide 20mg on d1,4,8,11;ifosfamide 1.2g/ m2，d1-4,ivg during 4 hours; Mesna 0.4g, 0,4,8 hours during Ifosfamide transfusion, ivg, d1-4; Carboplatin AUC=4, d2,ivg; etoposide 65mg/m 2, d1-4, ivg. 3 weeks as 1 course, for 6 courses.
if the effect is PR or better than PR, go to auto-stem cell transplantation, no further treatment with Chidamide is needed.
If the effect is PR or better than PR and no auto-stem cell transplantation available,Chidamide 20mg orally, twice every week, till the end of the trial. Receives: Drug: Chidamide with ICE regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective remission rate
Measured: through study completion, an average of 30 months
Secondary outcomes (21)
Duration of remission
Measured: through study completion, an average of 30 months
progress free survival
Measured: through study completion, an average of 30 months
overall survival
Measured: through study completion, an average of 30 months
white blood cell count
Measured: every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
red blood cell count
Measured: every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
blood Hb level
Measured: every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
blood platelet count
Measured: every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
vital signs
Measured: every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum alanine aminotransferase level
Measured: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum aspartate transaminase level
Measured: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum total bilirubin level
Measured: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum direct bilirubin level
Measured: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum indirect bilirubin level
Measured: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum glutamyltranspeptidase level
Measured: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum albumin level
Measured: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum ureal nitrogen level
Measured: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum creatinin level
Measured: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
fasting blood glucose level
Measured: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+）
Measured: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
blood LDH level
Measured: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
QTc from ECG
Measured: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2019 (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.
- 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuankai Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuankai Shi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856997
- Sponsor's protocol ID
- CancerIHCAMS 16-059/1138
- Status last verified
- Jul 2016
- First submitted
- 24 Jul 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: the data of the trial would be open to the public after the trial is finished
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma: A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT02856997
- Acronym / sponsor ID
- CancerIHCAMS 16-059/1138
- Conditions
- Peripheral T Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Yuankai ShiUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2019 (estimated)
- First posted
- 5 Aug 2016 (estimated)
- 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 study is to evaluate the efficacy and safety of Chidamide with ICE regimen in patients with relapsed/refractory Peripheral T Cell lymphoma.
Detailed description
Efficacy of the combined regimen is evaluated primarily by objective remission rate, including complete remission, unverified complete remission and partial remission, also by duration of remission, progression free survival, and overall survival.
Safety is accessed by:
- The type, incidence, severity of incidents related to the use of the regimen.
- Laboratory abnormalities, including the type, incidence, severity, relationship with the use of the regimen.
- Incidence of level 3-4 incidents and laboratory abnormalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide with ICE regimen | Experimental | Drug: Chidamide with ICE regimenDrugs:Chidamide and ICE regimen (ifosfamide, Mesna,Carboplatin and etoposide): Chidamide 20mg on d1,4,8,11;ifosfamide 1.2g/ m2，d1-4,ivg during 4 hours; Mesna 0.4g, 0,4,8 hours during Ifosfamide transfusion, ivg, d1-4; Carboplatin AUC=4, d2,ivg; etoposide 65mg/m 2, d1-4, ivg. 3 weeks as 1 course, for 6 courses. if the effect is PR or better than PR, go to auto-stem cell transplantation, no further treatment with Chidamide is needed. If the effect is PR or better than PR and no auto-stem cell transplantation available,Chidamide 20mg orally, twice every week, till the end of the trial. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with Peripheral T Cell Lymphoma (PTCL) verified by histopathology/ cytology, according to WHO 2008 classification criteria, including: adult T cell lymphoma or leukemia (human T cell leukemia virus 1 positive); angioimmunoblastic t cell lymphoma; ALK positive anaplastic large cell lymphoma; ALK negative anaplastic large cell lymphoma; non-specified peripheral T cell lymphoma; extra-nodal NK/T cell lymphoma; bowl disease related T cell lymphoma; hepatosplenic T cell lymphoma; subcutaneous panniculitis-like T cell lymphoma; allergic mycosis fungoides.
- There is at least 1 focus that could be evaluated both by histopathology and cytology (˃1.5cm) according to Cheson criteria.
- The patients should have had at least 1 course of systemic treatment (including chemo-therapy, stem cell transplantation etc), but did not achieve remission or had relapse after remission.
- Age18-75 years, male or female;
- General condition should be ECOG 0-1.
Key exclusion criteria (12 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.
- Patients who have received organ transplantation.
- Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
- Patients with active hemorrhage.
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 with ICE regimenAlso: Epidaza，HBI-8000Chidamide and ICE regimen, dosage described in arm description | Drug | Chidamide with ICE regimen |
Primary outcome
Objective remission rate
Time frame: through study completion, an average of 30 months
21 secondary outcomes
Duration of remission
Time frame: through study completion, an average of 30 months
progress free survival
Time frame: through study completion, an average of 30 months
overall survival
Time frame: through study completion, an average of 30 months
white blood cell count
Time frame: every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
red blood cell count
Time frame: every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
blood Hb level
Time frame: every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
blood platelet count
Time frame: every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
vital signs
Time frame: every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum alanine aminotransferase level
Time frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum aspartate transaminase level
Time frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum total bilirubin level
Time frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum direct bilirubin level
Time frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum indirect bilirubin level
Time frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum glutamyltranspeptidase level
Time frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum albumin level
Time frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum ureal nitrogen level
Time frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Serum creatinin level
Time frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
fasting blood glucose level
Time frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+）
Time frame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
blood LDH level
Time frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
QTc from ECG
Time frame: every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Individual participant dataSharing planned: Yes. the data of the trial would be open to the public after the trial is finished
Related trials for Peripheral T Cell Lymphoma
RecruitingPhase 1
Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma
Recurrent Anaplastic Large Cell Lymphoma, Recurrent Enteropathy-Associated T-Cell Lymphoma
RecruitingObservational study
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Hematologic Malignancy, Leukemia
Active, not recruitingPhase 1/2
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
Anaplastic Large Cell Lymphoma, Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
RecruitingObservational study
Characterization of the Microbiome in Cutaneous T Cell Lymphoma
Cutaneous T Cell Lymphoma
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide with ICE regimen in people with Peripheral T Cell Lymphoma, run by Yuankai Shi.
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 12 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 Aug 2016. 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 Yuankai Shi, Doctor (86-15821531560, drshiyuankai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective remission rate (time frame: through study completion, an average of 30 months). 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 Aug 2016.