Using low-dose Decitabine with COP chemotherapy for relapsed DLBCL

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

This study is testing if adding a low dose of Decitabine to standard chemotherapy can help people with relapsed diffuse large B-cell lymphoma who haven't responded to other treatments.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Harbin Medical University (Academic / other)
• Drugs / interventions: Rituximab, chemotherapy, Cyclophosphamide, Doxorubicin
• Locations: 1 site (Harbin, Heilongjiang)
• Trial ID: NCT03494296 on ClinicalTrials.gov

What this trial studies

This study investigates the combination of low-dose Decitabine and the COP chemotherapy regimen in patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL). Decitabine acts as a DNA methyltransferase inhibitor, aiming to reverse DNA methylation and promote tumor cell differentiation or apoptosis. The study focuses on patients who have not responded to standard treatments and evaluates the effectiveness of this novel combination therapy. Participants will receive the D-COP regimen, which includes Decitabine alongside traditional chemotherapy agents.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed relapsed or refractory DLBCL.

Not a fit: Patients with severe organ dysfunction, active infections, or significant heart disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with relapsed DLBCL.

How similar studies have performed: While the use of Decitabine in combination therapies is promising, this specific approach has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Histopathology confirmed as DLBCL.
2. Relapsed and refractory patients.
3. Age ≥ 18 years old.
4. ECOG ≥ 3.
5. 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。
6. 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

Exclusion Criteria:

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

Where this trial is running

Harbin, Heilongjiang

• The First Affiliated Hospital of Harbin Medical University, Department of Hematology, Lymphoma Ward — Harbin, Heilongjiang, China (Recruiting)

Study contacts

• Study coordinator: Qi Zhou, Master

Conditions Lymphoma