A Prospective Study of Low-dose Decitabine Combined With COP Regimen in the Treatment of Relapsed and Refractory DLBCL

NCT03494296 | Recruiting FDA Drug

• 1 other identifier: Organization:FirstAHHarbinMU
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Decitabine is a cytosine analogue and is a specific DNA methyltransferase (DNMT) inhibitor. It directly inhibits DNMT by phosphorylating DNA and inhibits DNMT, thereby reversing DNA methylation and inducing tumor cells to Normal cell differentiation or induction of tumor cell apoptosis.Diffuse large B-cell lymphoma (DLBCL) is the most common pathological type in non-Hodgkin's lymphoma. The first-line chemotherapy regimen using Rituximab+Cyclophosphamide+Doxorubicin +Vincristine+Bonisone（R-CHOP）significantly increases the remission rate and disease-free survival of patients with DLBCL, but it is difficult to partially relapse. Long-term remission and survival rates in treating patients are not satisfactory.Due to the greater cardiac toxicity of adriamycin, more patients can not be uncomfortable, so the COP program is also widely used in patients with DLBCL, and achieved a good response rate.In 2008, the FDA had approved decitabine for the demethylation treatment of Myelodysplastic syndrome（MDS）. Over the years, good initial remission rates and better long-term survival rates have been achieved in patients with MDS.There are also a variety of clinical trials of decitabine for patients with solid tumors that have achieved significant clinical efficacy.Due to the high side effects of high-dose decitabine, patient tolerance is poor. Therefore, the purpose of this study was to evaluate the efficacy and safety of low-dose decitabine combined with Cyclophosphamide+Vindesine+Bonisone(COP) regimen (D-COP) 4-6 course of treatment for relapsed and refractory diffuse large B-cell lymphoma.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• A Prospective Study of Low-dose Decitabine Combined With COP Regimen in the Treatment of Relapsed and Refractory DLBCL

  Primary end point: Using 5-year progression-free survival (PFS) as an index to evaluate the clinical effect of low-dose decitabine combined with COP chemotherapy.clinical efficacy of low-dose decitabine combined with COP regimen chemotherapy. Efficacy assessment criteria:2007 revised standards for international lymphoma efficacy: J Clin Oncol 2007;25(5):579-586.

  From March 1, 2018 to December 31, 2020

Study Arms (1)

Open, multi-center, prospective

All enrolled and relapsed patients received D-COP regimen chemotherapy

Drug: patients received D-COP regimen chemotherapy

Interventions

patients received D-COP regimen chemotherapy DRUG

patients received D-COP regimen chemotherapy

Open, multi-center, prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Plans to enroll 150 cases within 2 years

You may qualify if:

• Histopathology confirmed as DLBCL.
• Relapsed and refractory patients.
• Age ≥ 18 years old.
• ECOG ≥ 3.
• Women are not lactating, not pregnant, and agree not to become pregnant during the study period and within the next 12 months. Male patients agree that their spouse is not pregnant during the study period and within the next 12 months。
• There is an assessable lesion (lymph node diameter ≥ 1.0cm; or a dermatologic lesion that can be assessed by a physical examination)Signed informed consent

You may not qualify if:

• Bone marrow involvement and lymphoma cells ≥ 25%.
• Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine\> 3 times the upper limit of normal).
• Uncontrolled active infections.
• Organic heart disease and clinical symptoms or abnormal heart function (NYHA ≥ 2).
• Simultaneous presence of other tumors.
• Other psychological conditions that prevent patients from participating in the study or signing informed consent

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Harbin Medical University, Department of Hematology, Lymphoma Ward

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Shuye Wang, PhD

  First Affiliated Hospital of Harbin Medical University

  STUDY CHAIR

Central Study Contacts

Qi Zhou, Master

CONTACT

0451-85552320; kykbgs123@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the lymphoma ward

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 11, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2020
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

CN (1)