Clinical trial NCT02856997: Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma
Official title: Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma: A Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral T Cell Lymphoma
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
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:

1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
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.

Primary outcomes:
measure: Objective remission rate
timeFrame: through study completion, an average of 30 months
Secondary outcomes:
measure: Duration of remission
timeFrame: through study completion, an average of 30 months
measure: progress free survival
timeFrame: through study completion, an average of 30 months
measure: overall survival
timeFrame: through study completion, an average of 30 months
measure: white blood cell count
timeFrame: 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
measure: red blood cell count
timeFrame: 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
measure: blood Hb level
timeFrame: 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
measure: blood platelet count
timeFrame: 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
measure: vital signs
timeFrame: 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
measure: Serum alanine aminotransferase level
timeFrame: 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
measure: Serum aspartate transaminase level
timeFrame: 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
measure: Serum total bilirubin level
timeFrame: 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
measure: Serum direct bilirubin level
timeFrame: 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
measure: Serum indirect bilirubin level
timeFrame: 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
measure: Serum glutamyltranspeptidase level
timeFrame: 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
measure: Serum albumin level
timeFrame: 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
measure: Serum ureal nitrogen level
timeFrame: 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
measure: Serum creatinin level
timeFrame: 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
measure: fasting blood glucose level
timeFrame: 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
measure: blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+）
timeFrame: 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
measure: blood LDH level
timeFrame: 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
measure: QTc from ECG
timeFrame: 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
Other outcomes:
Locations:
Study officials:
References: