Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorFirst Affiliated Hospital of Harbin Medical University
Academic / other
Drugs / interventionsRituximab, chemotherapy, Cyclophosphamide, Doxorubicin
Locations1 site (Harbin, Heilongjiang)
StatusRecruiting
StartedMarch 1, 2018
Main results expectedDecember 31, 2020
Study endsDecember 31, 2026
Registry record updatedApril 11, 2018
Trial IDNCT03494296 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.