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

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mingzhi Zhang
• Treatments: Azacitidine; Decitabine

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.