Chidamide Combined With VDDT Regimen in the Relapse and Refractory Diffuse Large B Cell Lymphoma

• Status: Unknown status
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide combined with VDDT(vinorelbine，liposomal doxorubicin，dexamethasone and thalidomide) in relapsed and refractory patients with diffuse large B-cell lymphoma(DLBCL).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Histone Deacetylase Inhibitors; Liposomal doxorubicin; Mitoxantrone; Thalidomide; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

1. Diagnosed as diffuse large B-cell Lymphoma based on the 2008 WHO classification of tumors of haematopoietic and lymphoid tissues

2. Failed with second-line therapy

3. Having at least one measurable lesions

4. Age between 18 to 75 years old

5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1

6. Neutrophils more than 1.5*10^9/L; Platelets more than 90*10^9/L Hemoglobin: more than 90g/L.

7. Life expectancy no less than 3 months

8. No receiving chemotherapy in 4 weeks before enrollment

9. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Pregnant ，lactating and patients at reproductive age who refuse to practice contraception

2. QTc prolonging >450ms，ventricular tachycardia，atrial fibrillation，cardiac conduction block， myocardial infarction in less than 1 year， congestive heart failure，coronary heart disease which needs medication.

3. Organ transplant recipients

4. Active bleeding

5. Thrombus，embolism，cerebral hemorrhage，cerebral infarction

6. Important organ operation in less than 6 weeks

7. Abnormal liver function（Note：total bilirubin >1.5 times the upper limit of normal，AST or ALT >2.5 times the upper limit of normal （Note：5 times the upper limit of normal for patients with liver involvement）），abnormal renal function（Note：serum creatinine >1.5 times the upper limit of normal），fluid and electrolyte disorders

8. Mental illness or unable to sign the informed consent

9. Drug addiction history or alcoholism which may interfere the experimental results.

10. Researchers determine unsuited to participate in this trial

11. Known allergy to any kind of study drugs