Chidamide With R-CHOP Regimen for DLBCL Patients

Zhejiang University

Status and phase: Unknown; Phase 2

Conditions: Diffuse Large B Cell Lymphoma

Treatments: Drug: Chidamide + R-CHOP regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT03201471

lymphoma center Q001

Details and patient eligibility

About

It's a prospective, single arm, open label phase II clinical trial, in which the safety and efficacy of Chidamide plus R-CHOP regimen is accessed in de novo DLBCL patients, who have received 2 courses of R-CHOP but only achieved PR or whose MRD tests for ctDNA revealed positive results.

abbreviation: R-CHOP: the chemo-therapy regimen composed of Rituximab, cyclophosphoamide, etoposide, vincristine and prednisone.

PR: partial remission; MRD:minimal residual disease;

Enrollment: 39 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results;
2. Age between 18 to 75 years old;
3. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2;
4. No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment;
5. Life expectancy no less than 6 months
6. The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures;
7. IPI mark>1.

Exclusion criteria

1. History of autologous stem cell transplantation;

2. History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;

3. With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;

4. Lymphoma originated in the central nervous system;

5. Left ventricular ejection fraction ≦50％

6. Abnormal lab results in enrollment:

   1. Neutrophil count: <1.5*109/L；
   2. Platelet count <75*109/L；
   3. AST or ALT >2 times the upper limit of normal level，AKP and total bilirubin >1.5 times the upper limit of normal level;
   4. serum creatinine >1.5 times the upper limit of normal level;

7. Other uncontrolled medical conditions which the investigators think might influence the results of the trial;

8. Patients with mental illnesses or other diseases that might not comply with the trial plan;

9. Women during pregnancy or lactation;

10. HIV positive patients;

11. HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

39 participants in 1 patient group

treatment group

Experimental group

Description:

In this group, the patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1; CTX 750mg/m2, ivgtt,d2; EPI 70mg/m2, ivgtt,d2; VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2, PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18; one cycle every 21 days； abbreviation： CTX： cyclophosphamide；EPI：etoposide；VCR： vincristine；Pred：prednisone； R-CHOP：the chemo-therapy regimen composed of Rituximab, cyclophosphoamide; etoposide, vincristine and prednisone.

Treatment:

Drug: Chidamide + R-CHOP regimen