T-lymphoblastic Lymphoma
Conditions
Keywords
Decitabine, RR, TTP, OS, MST
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).
Interventions
COMBINATION_PRODUCTCODOX-M/IVAC
Given ivgtt
DRUGDecitabine
Given ivgtt
Sponsors
Mingzhi Zhang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RR | up to 2 months | Responder Rate |
| TTP | up to 2 months | Time To Progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | up to 2 months | Overall Survival |
| MST | up to 2 months | Median Survival Time |
Countries
China
Contacts
Primary ContactMingzhi zhang, Pro,Dr
Backup ContactMingzhi zhang
Outcome results
None listed