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

NCT05816746 | Recruiting Phase 2

• 1 other identifier: DP in R/R DLBCL-P01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Large B Cell Lymphoma; Relapse/Recurrence; Extranodal Extension; Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  ORR

  1-year

Secondary Outcomes (5)

• Clinical Benefit Rate

  1-year

• Progression Free Survival

  1-year

• Duration of Remission

  1-year

• Time to Response

  1-year

• Overall Survival

  1-year

Study Arms (1)

Treatment group

EXPERIMENTAL

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

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

Interventions

Low-Dose Decitabine plus anti-PD-1 DRUG

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

Also known as: DP

Treatment group

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

ChinaPLAGH

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 31039052 RESULT

• 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.

  PMID: 30620669 RESULT

• 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.

  PMID: 32187361 RESULT

• 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.

  PMID: 28356247 RESULT

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence; Extranodal Extension

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: May 15, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)