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Diffuse Large B Cell LymphomaPhase 2NCT05816746

Decitabine and Anti-PD-1 in R/R DLBCL

A Phase 2 study testing Low-Dose Decitabine plus anti-PD-1 in people with Diffuse Large B Cell Lymphoma and Relapse/Recurrence, run by Chinese PLA General Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. Read more about this study

Who is it for?
Ages 14 to 80 years
What is being tested?
Low-Dose Decitabine plus anti-PD-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
15 May 2023to 1 Mar 2026
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 14 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 14-80 years old, male or female;
  • Pathologically confirmed relapsed/refractory diffuse large B cell lymphoma with extranodal (central nervous system) involvement;
  • Expected survival of more than 3 months;
  • AST and ALT ≤ 3.0 ULN; TBIL and CCr ≤ 1.0 ULN;
  • Inactive infection and severe mental illness
  • ECOG score 0~2
Show all 9Show fewer
  • According to the New York Heart Association (NYHA) cardiac function grading standards, the heart function grading should be grade I or Grade II; Cardiac ejection fraction >50% or not lower than the lower limit of the range of laboratory test values at the study center; No pathological abnormality was found in ECG; There was no clinically significant pericardial effusion or pleural effusion
  • The serum pregnancy test of female subjects must be negative
  • Signed informed consent

Who cannot join

  • Subjects with any autoimmune disease requiring long-term use of corticosteroids or immunosuppressive drugs or with a history of other tumors;
  • Severe uncontrolled medical disease or active infection (including HIV+);
  • Active gastrointestinal bleeding or 1 month history of gastrointestinal bleeding;
  • Received allogeneic hematopoietic stem cell transplantation within 6 months or are participating in other clinical studies;
  • Pregnant or nursing women;
  • Subjects who must be forcibly detained for the treatment of mental or physical diseases (e.g. infectious diseases);
  • The researcher thinks it is not suitable for this clinical study (such as poor compliance, drug abuse, etc.)
  • The situation that the researcher judged was not suitable for inclusion

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • ChinaPLAGH

    Beijing, Beijing Municipality, 100853

    Yu Zhao, Graduate, 010-66937232, zhaoyu301@126.com

    Sai Huang, Graduate, 010-66937232, helinahs@qq.com

    Recruiting

Other trials in China

About this study

Official title: Low-Dose Decitabine Plus Anti-PD-1 Treatment for Relapsed/Refractory Diffuse Large B Cell Lymphoma With Extranodal (Esp. Central Nervous System) Involvement: A PhaseⅡClinical Trial

Patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. 3 weeks for a cycle, with a total of 2 years or until the disease progress esor unacceptable toxicity occurs, or the patient decides to withdraw from the trial.

Read the detailed description

To evaluate the effectiveness and safety of patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. 3 weeks for a cycle, with a total of 2 years or until the disease progress esor unacceptable toxicity occurs, or the patient decides to withdraw from the trial. Enrollment was planned to be completed within 2 years, and all trials were followed up for 12 months after the last enrolled patient completed treatment. All cases will be followed up and the long-term curative effect will be observed and recorded.

Being tested
Low-Dose Decitabine plus anti-PD-1
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Recurrence, Extranodal Extension

What participants receive

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

  • Low-Dose Decitabine plus anti-PD-1Drug

    Also called DP

    Decitabine 10mg/d，VD d1-5; PD-1 200mg，d8

Study groups in NCT05816746
Study groupRoleWhat they receive
Treatment groupExperimentalDecitabine 10mg/d，VD d1-5; PD-1 200mg，d8
Receives: Drug: Low-Dose Decitabine plus anti-PD-1

What is being measured

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

  1. Objective Response Rate

    ORR

    Measured: 1-year

Secondary outcomes (5)

  1. Clinical Benefit Rate

    The total percentage of subjects who achieved minimal response (MR) or above after treatment

    Measured: 1-year

  2. Progression Free Survival

    The time interval between first treatment and first recorded progress disease, or death from any cause, the deadline is the date of the last examination

    Measured: 1-year

  3. Duration of Remission

    The time interval from first recording to disease remission (PR and above criteria) to first recording to PD. For responding subjects with no documented disease progression, the deadline is the date of the last examination

    Measured: 1-year

  4. Time to Response

    The time interval between subjects first receiving treatment and first recording of disease remission (PR and above)

    Measured: 1-year

  5. Overall Survival

    The time interval between when the subject first received treatment and when death from any cause was recorded. For subjects whose death is not recorded, the deadline is the most recent point in time at which the subject is still alive

    Measured: 1-year

Timeline

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

  1. First posted18 Apr 2023
  2. Study start15 May 2023 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Mar 2026 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05816746
Sponsor's protocol ID
DP in R/R DLBCL-P01
Status last verified
May 2023
First submitted
5 Apr 2023
Last updated
9 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Low-Dose Decitabine plus anti-PD-1 treatment for relapsed/refractory diffuse large B cell lymphoma with extranodal (dsp. central nervous system) involvement: A phaseⅡclinical trial

Publications

  • Nie J, Wang C, Liu Y, Yang Q, Mei Q, Dong L, Li X, Liu J, Ku W, Zhang Y, Chen M, An X, Shi L, Brock MV, Bai J, Han W. Addition of Low-Dose Decitabine to Anti-PD-1 Antibody Camrelizumab in Relapsed/Refractory Classical Hodgkin Lymphoma. J Clin Oncol. 2019 Jun 10;37(17):1479-1489. doi: 10.1200/JCO.18.02151. Epub 2019 Apr 30.

    PubMed 31039052

  • Ansell SM, Minnema MC, Johnson P, Timmerman JM, Armand P, Shipp MA, Rodig SJ, Ligon AH, Roemer MGM, Reddy N, Cohen JB, Assouline S, Poon M, Sharma M, Kato K, Samakoglu S, Sumbul A, Grigg A. Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study. J Clin Oncol. 2019 Feb 20;37(6):481-489. doi: 10.1200/JCO.18.00766. Epub 2019 Jan 8.

    PubMed 30620669

  • Lacy SE, Barrans SL, Beer PA, Painter D, Smith AG, Roman E, Cooke SL, Ruiz C, Glover P, Van Hoppe SJL, Webster N, Campbell PJ, Tooze RM, Patmore R, Burton C, Crouch S, Hodson DJ. Targeted sequencing in DLBCL, molecular subtypes, and outcomes: a Haematological Malignancy Research Network report. Blood. 2020 May 14;135(20):1759-1771. doi: 10.1182/blood.2019003535.

    PubMed 32187361

  • Nayak L, Iwamoto FM, LaCasce A, Mukundan S, Roemer MGM, Chapuy B, Armand P, Rodig SJ, Shipp MA. PD-1 blockade with nivolumab in relapsed/refractory primary central nervous system and testicular lymphoma. Blood. 2017 Jun 8;129(23):3071-3073. doi: 10.1182/blood-2017-01-764209. Epub 2017 Mar 29.

    PubMed 28356247

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low-Dose Decitabine plus anti-PD-1 in people with Diffuse Large B Cell Lymphoma and Relapse/Recurrence, run by Chinese PLA General Hospital at 1 site in China.

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 9 inclusion and 8 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 9 May 2023. 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 China. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 1-year). 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 NCT05816746, which also lists 4 linked publications.

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 9 May 2023.

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