Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma
NCT ID: NCT02856997
Last Updated: 2016-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
35 participants
INTERVENTIONAL
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Retrospective Clinical Study on the First-line Maintenance Treatment of PTCL With Chidamide.
NCT05967949
PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma
NCT04040491
EZH2 Inhibitor Zeprumetostat in Combination Therapy for Patients With Relapsed or Refractory Mature T-cell and NK-cell Lymphomas
NCT07339527
Tofacitinib Combined With Chidamide in R/R ENKTCL
NCT03598959
Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)
NCT05833724
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Safety is accessed by:
1. The type, incidence, severity of incidents related to the use of the regimen.
2. Laboratory abnormalities, including the type, incidence, severity, relationship with the use of the regimen.
3. Incidence of level 3-4 incidents and laboratory abnormalities.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chidamide with ICE regimen
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.
Chidamide with ICE regimen
Chidamide and ICE regimen, dosage described in arm description
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Chidamide with ICE regimen
Chidamide and ICE regimen, dosage described in arm description
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. There is at least 1 focus that could be evaluated both by histopathology and cytology (˃1.5cm) according to Cheson criteria.
3. 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.
4. Age18-75 years, male or female;
5. General condition should be ECOG 0-1.
6. Blood routine test: absolute neutrophil count ≥1.5 × 109/L, platelet ≥80 × 109/L, Hb ≥ 90g/L;
7. Expected survival ≥ 3 months;
8. No radiotherapy, chemotherapy, targeted therapy or hemopoietic stem cell transplantation received within 4 weeks prior to enrollment.
9. Willing to sign the written consent.
Exclusion Criteria
2. 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.
3. Patients who have received organ transplantation.
4. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
5. Patients with active hemorrhage.
6. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
7. Patients with active infection, or with continuous fever within 14 days prior to enrollment.
8. Had major organ surgery within 6 weeks prior to enrollment.
9. 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).
10. Patients with mental disorders or those do not have the ability to consent.
11. Patients with drug abuse, long term alcoholism that may impact the results of the trial.
12. Non-appropriate patients for the trial according to the judgment of the investigators.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yuankai Shi
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yuankai Shi
Dr.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CancerIHCAMS 16-059/1138
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.