Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05816746
Other study ID # DP in R/R DLBCL-P01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 15, 2023
Est. completion date March 1, 2026

Study information

Verified date May 2023
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 1, 2026
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 14 Years to 80 Years
Eligibility Inclusion Criteria: - 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 - 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 Exclusion Criteria: - 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

Study Design


Intervention

Drug:
Low-Dose Decitabine plus anti-PD-1
Decitabine 10mg/d,VD d1-5; PD-1 200mg,d8

Locations

Country Name City State
China ChinaPLAGH Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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 i — View Citation

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 Haematolog — View Citation

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/b — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate ORR 1-year
Secondary Clinical Benefit Rate The total percentage of subjects who achieved minimal response (MR) or above after treatment 1-year
Secondary 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 1-year
Secondary 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 1-year
Secondary Time to Response The time interval between subjects first receiving treatment and first recording of disease remission (PR and above) 1-year
Secondary 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 1-year
See also
  Status Clinical Trial Phase
Recruiting NCT04670029 - Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line Phase 3
Active, not recruiting NCT04572763 - Copanlisib Plus Venetoclax in R/R DLBCL Phase 1/Phase 2
Active, not recruiting NCT04526834 - Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Phase 1
Recruiting NCT03676504 - Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR Phase 1/Phase 2
Recruiting NCT05365659 - IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas Phase 1
Completed NCT03287817 - CD19/22 CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell Lymphoma Phase 1/Phase 2
Enrolling by invitation NCT05645744 - Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.
Completed NCT04316624 - A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy Phase 1
Active, not recruiting NCT04555811 - FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL Phase 1
Terminated NCT04189952 - Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma Phase 2
Recruiting NCT01949818 - Treatment of Diffuse Large B Cell Lymphoma Phase 4
Completed NCT01459887 - Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma Phase 3
Completed NCT03242902 - To Decrease Fatigue With Light Therapy Phase 3
Recruiting NCT04104776 - A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas Phase 1/Phase 2
Recruiting NCT05018520 - The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk Phase 3
Withdrawn NCT04052061 - QUILT-3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell Lymphoma Phase 1
Recruiting NCT05020392 - Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma Phase 3
Recruiting NCT05006716 - A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies Phase 1/Phase 2
Completed NCT03297424 - A Study of PLX2853 in Advanced Malignancies. Phase 1
Recruiting NCT04545762 - Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma Phase 1