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| Name | Class |
|---|---|
| Beijing Longfu Hospital | UNKNOWN |
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This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with chidamide in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma.
Azacytidine was given subcutaneously at a dose of 75 mg/m2 on days 1-7. Chidamide was an oral tablet which was administered 20mg twice weekly. This regimen was repeated every 28 days. Treatment was given until disease progression, unacceptable toxicity, or patient/investigator discretion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azacytidine combined with chidamide | Experimental | Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacitidine | Drug | 75 mg/m2 subcutaneously on days 1-7 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was defined as the proportion of patients who achieved CR or PR as their best response | 1year |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | PFS was defined as time from diagnosis to the date of disease progression or death from any cause or the last follow-up. | 1 year |
| Duration of response (DOR) | DOR was defined as the time from the first occurrence of CR or PR to the first diagnosis of PD or relapse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chong Wei, Dr | Contact | +86 13521760705 | QH5035@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zhang, Dr | Peking Union Medical College Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D007119 | Immunoblastic Lymphadenopathy |
| ID | Term |
|---|---|
| D000072281 | Lymphadenopathy |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Chidamide |
| Drug |
20mg orally per week continuously |
|
| through study completion, an average of 1 year |
| overall survival (OS) | OS was defined as time from diagnosis to death from any cause or the last follow-up. | through study completion, an average of 2 year |
| Adverse Events | Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | During the whole treatment |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |