UnknownPhase 4

A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma

China30 participantsStarted 2016-10-01

Plain-language summary

To observe the safety, tolerability and clinical effects of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma.

Age range10 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓.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.
✓0.Can understand the situation of this study and sign the informed consent voluntarily

✕. rejecting providing blood preparation;
✕. allergic to drug in this study or with hemophagocytic syndrome;
✕. rejecting adopting reliable contraceptive method in pregnancy or lactation period;
✕. uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas）；
✕. with severe infection;
✕. with primary or secondary central nervous system tumor invasion;
✕. with Chemotherap or radiotherapy contraindication;
✕. ever suffered with malignant tumor;

Objective Response Rate (ORR)

Timeframe: up to 24 months

NCT IDNCT04490590

SponsorMingzhi Zhang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-01

Lei Zhang, Professor

Who can participate

Age range10 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓.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.
✓0.Can understand the situation of this study and sign the informed consent voluntarily

✕. rejecting providing blood preparation;
✕. allergic to drug in this study or with hemophagocytic syndrome;
✕. rejecting adopting reliable contraceptive method in pregnancy or lactation period;
✕. uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas）；
✕. with severe infection;
✕. with primary or secondary central nervous system tumor invasion;
✕. with Chemotherap or radiotherapy contraindication;
✕. ever suffered with malignant tumor;