A Clinical Trial of Decitabine in Relapse and Refractory Diffuse Large B Cell Lymphoma

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To explore the safety, tolerability and clinical effects of decitabine combined with R±DHAP for patients with replase and refractory Diffuse Large B cell lymphoma.

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

Details

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

Criteria

Inclusion Criteria:

• age:14-65 years;ECOG rate≤2;expected survival≥3 months

• patients with Diffuse Large B cell lymphoma diagnoesd by histopathology detection;

• patients ever received RCHOP or CHOP chemotherapy but did not receive DHAP

• patients never received radiotherapy

• patients with no chemotherapy contraindications:hemoglobin ≥ 90g/L,absoluate neutrophil count ≥1.5x109/L,blood platelet ≥100x109/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 ≥ 30g/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.