Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma
1 other identifier
interventional
35
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedAugust 5, 2016
July 1, 2016
2.5 years
July 24, 2016
August 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Objective remission rate
through study completion, an average of 30 months
Secondary Outcomes (21)
Duration of remission
through study completion, an average of 30 months
progress free survival
through study completion, an average of 30 months
overall survival
through study completion, an average of 30 months
white blood cell count
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
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
- +16 more secondary outcomes
Study Arms (1)
Chidamide with ICE regimen
EXPERIMENTALDrugs: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.
Interventions
Chidamide and ICE regimen, dosage described in arm description
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yuankai Shilead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
July 24, 2016
First Posted
August 5, 2016
Study Start
September 1, 2016
Primary Completion
March 1, 2019
Last Updated
August 5, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will share
the data of the trial would be open to the public after the trial is finished