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This is a single-arm, open-label phase 2study of Chidamide in combination with CHOP in the treatment of subjects with untreated angioimmunoblastic T cell lymphoma.
This open-label, single arm study will evaluate the efficacy and safety of chidamide in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy in previously untreated subjects with angioimmunoblastic T cell lymphoma. Subjects will receive 6 cycles of Chidamide 20mg, day 1,4,8,11, orally (PO) every 21 days, in addition to 6 cycles of CHOP chemotherapy IV every 21 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide plus CHOP | Experimental | Participants received six 21-day cycles of chidamide, combined with six cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy (21-day cycles). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | Chidamide 20mg per day administered orally on Day 1, 4, 8, 11 of each 21-day cycle for 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria | At the end of Cycle 6 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Percentage of participants with response(complete response and partial response) was determined on the basis of investigator assessments according to 2014 Lugano criteria | At the end of Cycle 6 (each cycle is 21 days) |
| Progression free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating free Deoxyribonucleic Acid (cfDNA) monitoring | cfDNA in peripheral blood assessed by local lab | Baseline up to data cut-off (up to approximately 4 years) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weili Zhao, MD. PhD | Ruijin Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin hospital | Shanghai | Shanghai Municipality | 200025 | 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 |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Cyclophosphamide | Drug | Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle. |
|
| Doxorubicin | Drug | Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle. |
|
| Vincristine | Drug | Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle. |
|
| Prednisone | Drug | Prednisone 60mg/m2 , Maximum 100 mg , (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle. |
|
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first. |
| Baseline up to data cut-off (up to approximately 4 years) |
| Overall survival | Overall survival in the overall study population was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. | Baseline up to data cut-off (up to approximately 4 years) |
| Duration of response | time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT. | Baseline up to data cut-off (up to approximately 4 years) |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to data cut-off (up to approximately 4 years) |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores | The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants. | Baseline (pre-dose [Hour 0] on Cycle1 Day1), Cycle3 Day 1, end of treatment (up to Month 6), every 3 months 1st year, every 6 months 2nd year, and 12 months thereafter up to data cut-off, up to approximately 4 years (cycle length = 21 days) ] |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |