Using low-dose Decitabine with COP chemotherapy for relapsed DLBCL
Official title: A Prospective Study of Low-dose Decitabine Combined With COP Regimen in the Treatment of Relapsed and Refractory DLBCL
Run by First Affiliated Hospital of Harbin Medical University · NCT03494296 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | First Affiliated Hospital of Harbin Medical University Academic / other |
| Drugs / interventions | Rituximab, chemotherapy, Cyclophosphamide, Doxorubicin |
| Locations | 1 site (Harbin, Heilongjiang) |
| Status | Recruiting |
| Started | March 1, 2018 |
| Main results expected | December 31, 2020 |
| Study ends | December 31, 2026 |
| Registry record updated | April 11, 2018 |
| Trial ID | NCT03494296 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with histopathologically confirmed relapsed or refractory DLBCL.
✕Probably not a fit
Patients with severe organ dysfunction, active infections, or significant heart disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the use of Decitabine in combination therapies is promising, this specific approach has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
The First Affiliated Hospital of Harbin Medical University, Department of Hematology, Lymphoma Ward
Harbin, Heilongjiang, China Recruiting
Study contacts
- Study coordinator: Qi Zhou, Master
- Email: kykbgs123@163.com
- Phone: 0451-85552320
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.