A Clinical Trial of Decitabine in Relapsed or Refractory T-lymphoblastic Lymphoma
- Conditions
- T-lymphoblastic Lymphoma
- Interventions
- Combination Product: CODOX-M/IVAC
- Registration Number
- NCT03558412
- Lead Sponsor
- Mingzhi Zhang
- Brief Summary
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.
- Detailed Description
This is a prospective, open，investigator initial clinical trial with a single arm, aimed to evaluate the safety, tolerability, and efficacy of decitabine combined with Second-line chemotherapy regimens (CODOX-M/IVAC) in relapsed or refractory T-lymphoblastic lymphoma. A total of 40 patients are planned to be enrolled into the study. Patients with diagnosis of relapsed or refractory T-lymphoblastic lymphoma will be treated with decitabine plus CODOX-M/IVAC. The primary end point is responder rate (RR) and time to progression (TTP), and the secondary end points include overall survival (OS) and the median survival time (MST).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A CODOX-M/IVAC Decitabine+CODOX-M/IVAC for patients with relapsed or refractory T-lymphoblastic lymphoma who used Hyper-CVAD or BFM-90 as first-line therapy:regimen A:CODOX-M:cyclophosphamide,epirubicin,vincristine,methotrexate.Regimen B :IVAC:ifosfamide,etoposide，cytarabine.Decitabine,10mg,ivgtt,used for 5 days before A+B. Arm A Decitabine Decitabine+CODOX-M/IVAC for patients with relapsed or refractory T-lymphoblastic lymphoma who used Hyper-CVAD or BFM-90 as first-line therapy:regimen A:CODOX-M:cyclophosphamide,epirubicin,vincristine,methotrexate.Regimen B :IVAC:ifosfamide,etoposide，cytarabine.Decitabine,10mg,ivgtt,used for 5 days before A+B.
- Primary Outcome Measures
Name Time Method RR up to 2 months Responder Rate
TTP up to 2 months Time To Progression
- Secondary Outcome Measures
Name Time Method OS up to 2 months Overall Survival
MST up to 2 months Median Survival Time
Trial Locations
- Locations (1)
Oncology Department of The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China