Clinical trial NCT03558412: A Clinical Trial of Decitabine in Relapsed or Refractory T-lymphoblastic Lymphoma
Official title: A Clinical Trial of Decitabine Combined With CODOX-M/IVAC in Relapsed or Refractory T-lymphoblastic Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: T-lymphoblastic Lymphoma
Keywords: Decitabine
RR
TTP
OS
MST
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: RR
timeFrame: up to 2 months
measure: TTP
timeFrame: up to 2 months
Secondary outcomes:
measure: OS
timeFrame: up to 2 months
measure: MST
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Oncology Department of The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Mingzhi zhang
role: PRINCIPAL_INVESTIGATOR
References: