T-lymphoblastic Lymphoma Clinical Trial
Official title:
A Clinical Trial of Decitabine Combined With CODOX-M/IVAC in Relapsed or Refractory T-lymphoblastic Lymphoma
To explore the safety, tolerability, and clinical effects of decitabine combined with Second-line chemotherapy regimens for patients with relapsed or refractory T-lymphoblastic lymphoma.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 1, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 60 Years |
Eligibility |
Inclusion Criteria: - age: 14~60 years; ECOG rate = 2; expected survival > 3 months; - patients with T-lymphoblastic lymphoma diagnosed by histopathology detection; - patients ever received chemotherapy and/or radiotherapy;and can not be transplanted hematopoietic stem cells; - patients with no chemotherapy contraindications: hemoglobin = 90 g/L, absolute neutrophil count =1.5 x 109/L, blood platelet =100 x 109/L, ALT and AST = 2-fold upper normal limit, serum bilirubin = 1.5-fold upper normal limit, serum creatinine = 1.5-fold upper normal limit, serum albumin = 30 g/L, normal serofibrinogen; - at least one measurable nidus; - no other severe diseases conflict with this project, cardiopulmonary function is basically normal; - the urine or blood pregnancy test of women in childbearing age must be negative in 7 days before follow-up visit; - applicable for follow-up visit; - no other antitumor adjoint therapy (including antitumor Chinese medicine, immunotherapy and biotherapy), but double phosphate anti-bone transfer therapy and other symptomatic treatment are acceptable; - understanding this study and assigning informed consent. Exclusion Criteria: - rejecting providing blood preparation; - allergic to drug in this study and with metabolic block; - 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 immunotherapy or radiotherapy contraindication; - ever suffered with malignant tumor; - having peripheral nervous system disorder or dysphrenia; - with no legal capacity, medical or ethical reasons affecting research proceeding; - participating other clinical trials simultaneously; - adopting other anti-tumor medicine excluding this research; - the researchers considering it inappropriate to participate in the study. |
Country | Name | City | State |
---|---|---|---|
China | Oncology Department of The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Mingzhi Zhang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RR | Responder Rate | up to 2 months | |
Primary | TTP | Time To Progression | up to 2 months | |
Secondary | OS | Overall Survival | up to 2 months | |
Secondary | MST | Median Survival Time | up to 2 months |
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