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

  • STATUS
    Recruiting
  • days left to enroll
    44
  • participants needed
    20
  • sponsor
    Henan Cancer Hospital
Updated on 24 January 2021
dexamethasone
doxorubicin
neutrophil count
b-cell lymphoma

Summary

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

Description

There are one third of diffuse large B-cell Lymphoma patients suffering relapse and refractory, which are the major cause of death among these patients. Vinorelbineliposomal doxorubicinmitoxantrone, dexamethasone and thalidomide have been used in the therapy of patients who failed with Second-line treatments in our center. This regimen is well tolerated but the effect needs to be improved. Chidamidea histone deacetylase inhibitor has been approved for the treatment of refractory T-cell lymphoma in China. The goal is to assess the efficacy and safety of chidamide combined with VDDTvinorelbineliposomal doxorubicindexamethasone and thalidomide in relapse and refractory patients with diffuse large B-cell Lymphoma.

Details
Condition Diffuse Large B-Cell Lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma
Treatment Dexamethasone, Vinorelbine, thalidomide, Chidamide, Liposomal Doxorubicin or mitoxantrone
Clinical Study IdentifierNCT02733380
SponsorHenan Cancer Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Diffuse Large B-Cell Lymphoma?
Do you have any of these conditions: Diffuse Large B-Cell Lymphoma or diffuse large b cell lymphoma or diffuse large cell lymphoma?
Diagnosed as diffuse large B-cell Lymphoma based on the 2008 WHO classification of tumors of haematopoietic and lymphoid tissues
Failed with second-line therapy
Having at least one measurable lesions
Age between 18 to 75 years old
World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1
Neutrophils more than 1.5 _10^9/L; Platelets more than 90_ 10^9/L Hemoglobin: more than 90g/L
Life expectancy no less than 3 months
No receiving chemotherapy in 4 weeks before enrollment
Agreeing to sign the written informed consents

Exclusion Criteria

Pregnant lactating and patients at reproductive age who refuse to practice contraception
QTc prolonging >450msventricular tachycardiaatrial fibrillationcardiac conduction block myocardial infarction in less than 1 year congestive heart failurecoronary heart disease which needs medication
Organ transplant recipients
Active bleeding
Thrombusembolismcerebral hemorrhagecerebral infarction
Important organ operation in less than 6 weeks
Abnormal liver functionNotetotal bilirubin >1.5 times the upper limit of normalAST or ALT >2.5 times the upper limit of normal Note5 times the upper limit of normal for patients with liver involvementabnormal renal functionNoteserum creatinine >1.5 times the upper limit of normalfluid and electrolyte disorders
Mental illness or unable to sign the informed consent
Drug addiction history or alcoholism which may interfere the experimental results
Researchers determine unsuited to participate in this trial
Known allergy to any kind of study drugs
Clear my responses

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