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Diffuse Large B Cell LymphomaPhase 2EPICNCT03719989

Azacitidine and Rituximab-GDP Immunochemotherapy in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Phase 2 study testing azacitidine plus R-GDP in people with Diffuse Large B Cell Lymphoma and Relapsed Non Hodgkin Lymphoma, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This phase II clinical trial aims at evaluating the efficacy and safety of azacitidine followed by rituximab-GDP immunochemotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Patients who were treated with from 1 to 4 lines of prior therapies for relapsed/refractory DLBCL wee eligible. Read more about this study

Who is it for?
Ages 19 to 75 years
What is being tested?
azacitidine plus R-GDP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteSouth Korea
Study dates
1 Dec 2018to 30 Nov 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age from 19 to 75 years
  • diagnosed as diffuse large B-cell lymphoma according to the World Health Organization 2016 criteria
  • with any measurable lesion by radiologic studies (direct measurement is allowed in cases of (sub)cutaneous lesions)
  • patients who were initially treated with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or other rituximab-containing immunochemotherapy and relapsed or refractory to prior treatment
  • previously treated with from1 to 4 lines of therapy
  • autologous stem cell transplant (ASCT) will be counted as 1 line of therapy
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  • in cases of previously treated with ASCT, patients 1) who elapsed at 60 days and 2) who have lower risk of severe bone marrow suppression and infectious complication, judged by physician
  • ASCT ineligible or no further plan of ASCT due to previous transplantation
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0~2
  • Hb ≥ 8.0 g/dL, absolute neutrophil count (ANC) ≥ 1,000/mm3, Platelet ≥ 100,000/mm3 prior to enrollment
  • correction of Hb by transfusion will be allowed
  • in cases of bone marrow involvement, patients will be included if they have ANC ≥ 500/mm3, Platelet ≥ 50,000/mm3 and no significant infection risk or transfusion dependency
  • Glomerular Filtration Rate > 60 mL/min calculated according to Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) equation, and total bilirubin < 2.5 mg/dL, aspartate amino-transferase (AST) and alanine amino- transferase (ALT) < x3 upper limit of normal (ULN)
  • In cases of hepatic involvement of DLBCL, AST or ALT < x5 ULN will be allowed
  • In cases of Gilbert syndrome, Direct bilirubin < 2.5 ULN will be allowed
  • patients who agree to do highly effective contraception during and 3 months after treatment
  • patients who agree not to be pregnant or breast-feeding and had a negative result for screening pregnancy test
  • life expectancy > 3 months

Who cannot join

  • primary or secondary central nervous system DLBCL
  • patients with or strongly suggestive of lymphomatous involvement on eye, epidural area, kidney/adrenal gland, breast, testes, or uterus
  • intravascular DLBCL
  • DLBCL transformed from low grade lymphoma
  • high grade B-cell lymphomas other than DLBCL: primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma not otherwise specified (NOS), high-grade B-cell lymphoma with myelocytomatosis oncogene (MYC) and/or B-cell lymphoma 6 (BCL6) rearrangements, B-cell lymphoma, unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma
  • human immunodeficiency virus (HIV) associated DLBCL
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  • patients with liver cirrhosis of Child-Pugh Classification B or higher, or active hepatitis B (HBV) or hepatitis C (HCV) infection
  • in cases of patients who are positive for HBsAg or HBcAb immunoglobulin G (IgG) but no evidence of active infection, patients who are negative for HBV DNA will be allowed only with adequate anti-viral prophylaxis
  • in cases of patients who are positive for hepatitis C antibody, patients will be allowed if they satisfy all other inclusion criteria and without evidence of liver cirrhosis (irrespective of HCV RNA titer)
  • patients who were diagnosed HCV less than 6 months before screening period will be excluded unless they have negative result for HCV RNA
  • patients with active infection treated with anti-microbial agents
  • patients who were diagnosed malignancy other than lymphoma, either actively treated or have been received chemotherapy or radiation therapy less than 3 years from the time of enrollment
  • Major surgery within 21 days (open laparotomy for diagnostic biopsy will be exempted)
  • patients who underwent hypersensitivity, severe allergic reaction or anaphylaxis to rituximab or other chimeric/humanized antibodies
  • patients who underwent hypersensitivity, severe allergic reaction or anaphylaxis gemcitabine, azacitidine, or cisplatin
  • severe congestive heart failure, unstable heart or pulmonary diseases
  • pregnant or lactating women
  • during radiation therapy to chest area (considering previous reports of severe esophagitis and pneumonitis after concurrent chemoradiation with gemcitabine)
  • with any prior experience of posterior reversible encephalopathy syndrome or progressive multifocal leukoencephalopathy due to rituximab
  • with any prior experience of Stevens-Jones syndrome or toxic epidermal necrosis

Trial locations and contacts

1 site in 1 country.

Junshik Hong, MD contact

82-2-2072-3383

alertjun@hanmail.net

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

    Junshik Hong, MD, 82220723383, alertjun@hanmail.net

Other trials in South Korea

About this study

Official title: A Phase II Study of Epigenetic Priming Using Azacitidine Followed by Rituximab-GDP Immunochemotherapy in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

This phase II clinical trial aims at evaluating the efficacy and safety of azacitidine followed by rituximab-GDP immunochemotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Patients who were treated with from 1 to 4 lines of prior therapies for relapsed/refractory DLBCL wee eligible. azacitidine will be treated one week prior to conventional rituximab-gemcitabine, dexamethasone, cisplatin (R-GDP) immunochemotherapy. Patients will be treated every 21 days as one cycle, and up to 6 cycles. The primary endpoint of this study is objective response rate according to the Lugano response criteria for non-Hodgkin lymphoma, and secondary endpoints are safety, complete response, progression-free survival, and overall survival.

Read the detailed description

This phase II clinical trial aims at evaluating the efficacy and safety of azacitidine followed by rituximab-GDP immunochemotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This study is designed with the expectation of correction of aberrant hypermethylation of tumor suppressor genes by preceding use of low dose azacitidine thereby re-sensitizing chemosensitivity of tumor cells. Patients who were treated with from 1 to 4 lines of prior therapies for relapsed/refractory DLBCL wee eligible. Planned initial doses of the current regimen are as follows;

azacitidine S.C 25 mg/m2 D1,2,3,4,5 rituximab I.V. 375 mg/m2 D8 gemcitabine I.V. 1,000 mg/m2, D8,15 dexamethasone I.V. or P.O. 40 mg D8,9,10,11 cisplatin 70 mg/m2 I.V. D8

Patients will be treated every 21 days as one cycle, and up to 6 cycles of treatment will be conducted. Especially, first 3~6 patients will be regarded as 'lead-in safety cohort' and their safety will be reviewed by an independent data and safety monitoring board (DSMB). The primary endpoint of this study is objective response rate according to the Lugano response criteria for non-Hodgkin lymphoma, and secondary endpoints are safety, complete response, progression-free survival, and overall survival.

Being tested
azacitidine plus R-GDP
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • azacitidine plus R-GDPDrug

    Also called N/E

    azacitidine S.C 25 mg/m2 D1,2,3,4,5 rituximab I.V. 375 mg/m2 D8 gemcitabine I.V. 1,000 mg/m2, D8,15 dexamethasone I.V. or P.O. 40 mg D8,9,10,11 every 21 days, up to 6 cycles

Study groups in NCT03719989
Study groupRoleWhat they receive
Treatment armExperimentalThis study is sing-arm study. Therefore, all enrolled patients will be treated with azacitidine plus R-GDP regimen
Receives: Drug: azacitidine plus R-GDP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    according to Lugano response criteria for non-Hodgkin lymphoma

    Measured: up to 3 years

Secondary outcomes (4)

  1. Safety (adverse events and severe adverse events)

    according to CTCAE V4.03 criteria

    Measured: up to 3 years

  2. Complete response rate

    according to Lugano response criteria for non-Hodgkin lymphoma

    Measured: up to 3 years

  3. Progression-free survival

    From date of enrollment until date of first documented progression or date of death from any cause, whichever came first

    Measured: up to 3 years

  4. Overall survival

    From date of enrollment until date of death from any cause

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2018
  2. Study start1 Dec 2018 (estimated)
  3. Primary completion30 Nov 2021 (estimated)
  4. Study completion30 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03719989
Sponsor's protocol ID
EPIC
Acronym
EPIC
Status last verified
Oct 2018
First submitted
15 Oct 2018
Last updated
25 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim DH, Kong JH, Hong J, Byun JM, Shin DY, Koh Y, Kim I, Park J, Do YR, Kim JA, Kim WS, Shin HJ, Yoon SS. Azacitidine followed by R-GDP in transplant-ineligible relapsed/refractory diffuse large B-cell lymphoma: preliminary results from a multicenter, phase II study. Ther Adv Hematol. 2025 Jul 11;16:20406207251349361. doi: 10.1177/20406207251349361. eCollection 2025.

    PubMed 40656663

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing azacitidine plus R-GDP in people with Diffuse Large B Cell Lymphoma and Relapsed Non Hodgkin Lymphoma, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Junshik Hong, MD (82-2-2072-3383, alertjun@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03719989, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.

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