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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02856997
Other study ID # CancerIHCAMS 16-059/1138
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received July 24, 2016
Last updated August 2, 2016
Start date September 2016

Study information

Verified date July 2016
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Yuankai Shi, Doctor
Phone 86-15821531560
Email drshiyuankai@163.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 35
Est. completion date
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Chidamide with ICE regimen
Chidamide and ICE regimen, dosage described in arm description

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Yuankai Shi

Outcome

Type Measure Description Time frame Safety issue
Primary Objective remission rate through study completion, an average of 30 months No
Secondary Duration of remission through study completion, an average of 30 months No
Secondary progress free survival through study completion, an average of 30 months No
Secondary overall survival through study completion, an average of 30 months No
Secondary 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 Yes
Secondary 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 Yes
Secondary blood Hb level 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 Yes
Secondary blood platelet 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 Yes
Secondary vital signs 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 Yes
Secondary Serum alanine aminotransferase level 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 Yes
Secondary Serum aspartate transaminase level 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 Yes
Secondary Serum total bilirubin level 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 Yes
Secondary Serum direct bilirubin level 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 Yes
Secondary Serum indirect bilirubin level 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 Yes
Secondary Serum glutamyltranspeptidase level 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 Yes
Secondary Serum albumin level 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 Yes
Secondary Serum ureal nitrogen level 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 Yes
Secondary Serum creatinin level 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 Yes
Secondary fasting blood glucose level 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 Yes
Secondary blood electrolytes level(K+, Na+,Cl-,Ca2+,Mg2+) 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 Yes
Secondary blood LDH level 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 Yes
Secondary QTc from ECG 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 Yes
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