Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma (PET: Prednisone, Etoposide and Thalidomide)
NCT ID: NCT03273452
Last Updated: 2017-09-25
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
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2017-03-01
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment group
In this group, patients will be given prednisone 100mg,qd,d1-5; etoposide 100mg,qd,d1-5; thalidomide 100mg,qn,d1-14; Chidamide 30mg,biw;
Chidamide
Chidamide will be given orally 30mg,biw, along with PET regimen (prednisone 100mg,po,qd,d1-5; etoposide 100mg,po,qd,d1-5; thalidomide 100mg,po,qn,d1-14;)
Interventions
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Chidamide
Chidamide will be given orally 30mg,biw, along with PET regimen (prednisone 100mg,po,qd,d1-5; etoposide 100mg,po,qd,d1-5; thalidomide 100mg,po,qn,d1-14;)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least on measurable focus (≥1.0\*1.0cm by imaging), or at least one evaluable focus;
3. Age 18-75 years, both male and female;
4. ECOG 0-2, KPS≥ 70points;
5. Expected survival ≥3 months;
6. Peripheral blood neutrophil count ≥1.5×10\^9/L, platelet count≥ 75×10\^9/L, Hb≥ 90g/L;
7. Liver function: bilirubin ≤1.5 times of the normal maximum; AST、ALT≤2 times of the normal maximum (for patients with liver infiltration AST、ALT≤3 times of the normal maximum); renal function: blood creatinine ≤2 times the normal maximum;
8. Negative random pregnancy test for fertile women patients within 7 days before enrollment;
9. No radiation therapy, chemotherapy, targeted therapy nor hemopoietic stem cell transplantation within 4 weeks before enrollment;
10. No anti-tumor therapy at enrollment, including herbal therapy, immunotherapy and biologic therapy, symptomatic treatment is not within this range;
Exclusion Criteria
2. Patients with other malignant tumors simultaneously that have not been effectively controlled;
3. Patients with history of using HDAC inhibitors;
4. Patients who are allergic to medicine used in the trial, or have metabolic disorders toward these medicine;
5. Patients with severe active infection;
6. Patients with HIV or syphilis infection;
7. Patients with prolonged QT interval (male \> 450ms，female \> 470ms), or chronic heart failure patients with level III or IV cardiac function; or those have the following heart disease within 6 months before enrollment: acute coronary syndrome, acute heart failure (heart function level III or IV), distinctive ventricular arrhythmias (prolonged ventricular tachycardia, ventricular fibrillation, etc);
8. Patients with history of organ transplantation;
9. Patients with history of thrombosis and embolism;
10. Patients with mental disorders or those who are unable to sign a written consent;
11. Patients with drug abuse or long-time alcoholism that may influence the result of the trial;
12. Patients who do not have capacity of legal transactions;
13. Patients currently in other clinical trials;
14. Those who are recognized as inappropriate for the trial by the investigators;
18 Years
75 Years
ALL
No
Sponsors
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Qingdao University
OTHER
Responsible Party
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Hongwei Xue
MD.
Locations
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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wang Y, Zhang M, Song W, Cai Q, Zhang L, Sun X, Zou L, Zhang H, Wang L, Xue H. Chidamide plus prednisone, etoposide, and thalidomide for untreated angioimmunoblastic T-cell lymphoma in a Chinese population: A multicenter phase II trial. Am J Hematol. 2022 May;97(5):623-629. doi: 10.1002/ajh.26499. Epub 2022 Mar 11.
Other Identifiers
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Xuehw001
Identifier Type: -
Identifier Source: org_study_id