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To observe the safety, tolerability and clinical effects of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma.
This is a prospective, open-label, one-arm, single center clinical trial, aimed to evaluate the safety, tolerability, and efficacy of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma. A total of 30 patients are planned to be enrolled into the study. Patients with diagnosis of Relapsed or Refractory NK/T-cell Lymphoma will be treated with Chidamide plus Etoposide capsules. The primary end points are objective responder rate (ORR) and a time to response(TTR) and response duration (DOR) and progression free survival(PFS) and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide+ Etoposide capsule | Experimental | Chidamide: 30mg, twice a week(BIW), PO. Etoposide capsule:50mg, quaque die (QD), PO, d1-10,21days for one cycle. Patients receive the other treatment of chidamide and etoposide capsule, and those who have achieved PD(progressive disease) will give the other treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide+ Etoposide | Drug | Patients will receive the treatment of and chidamide and etoposide capsule, and those who have achieved CR(complete response)or PR(partial response)or SD(stable disease)will continue the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time To Response (TTR) | Up to 3 months | |
| Duration of Response (DOR) | Up to 2 years | |
| Progression Free Survival (PFS) Progression Free Survival |
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Inclusion Criteria:
1.age:10-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3 months 2 patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH); 3.Refractory or relapse after at least 2 regimen 4.Once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence; 5.No chemotherapy contraindications: hemoglobin ≥ 100g / L, absolute neutrophil count ≥ 1.5 × 109 / L, platelets ≥ 80 × 109 / L, ALT, AST ≤ 2 times the upper limit of normal, serum total bilirubin ≤ 1.5 times normal Upper limit, serum creatinine ≥ 1.5 times normal upper limit, serum protein ≥ 30g / L; 6.At least one measurable lesion 7.There are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal; 8.Women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication; 9.There is no other antitumor treatment, but bisphosphonate for anti-bone metastasis treatment and other symptomatic treatment can be applied.
10.Can understand the situation of this study and sign the informed consent voluntarily
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Zhang, Professor | Contact | 13525533696 | zl2909@163.com | |
| Mingzhi Zhang, Professor | Contact | 138385656 | mingzhi_zhang@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Zhang, Professor | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Department of The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| up to 24 months |
| D009369 |
| Neoplasms |