Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma

Peripheral T Cell Lymphoma Clinical Trial

Official title:

Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma: A Phase II Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02856997
• Other study ID #: CancerIHCAMS 16-059/1138
• 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. 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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

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