A Clinical Trial of Decitabine in Relapsed or Refractory T-lymphoblastic Lymphoma

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Clinical Trial of Decitabine Combined With CODOX-M/IVAC in Relapsed or Refractory T-lymphoblastic Lymphoma

Conditions
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T-lymphoblastic Lymphoma

Intervention / Treatment
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* Combination Product: CODOX-M/IVAC
* Drug: Decitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>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. | Combination Product: CODOX-M/IVAC<br>* Given ivgtt<br>Drug: Decitabine<br>* Given ivgtt<br>* Other names: 5-Aza-2'-deoxycytidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RR | Responder Rate | up to 2 months | 
| TTP | Time To Progression | up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall Survival | up to 2 months | 
| MST | Median Survival Time | up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RR, Decitabine, TTP, OS, MST