Ibrutinib Combined With Rituximab for Treatment of Relapsed Refractory MYD88 and CD79A/B (or CD79B Alone) DLBCL Who Have Received at Least Two Prior Therapies

NCT04994626 | Unknown Phase 2

• 1 other identifier: NCC2613
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Ibrutinib Combined With Rituximab in Relapsed Refractory MYD88 and CD79A/B (or CD79B Alone) DLBCL Who Have Received at Least Two Prior Therapies.

Conditions

DLBCL; MYD88 Gene Mutation; CD79A Gene Mutation; CD79B Gene Mutation; Relapse; Refractory Lymphoma

Keywords

R/R DLBCL; MYD88 Gene Mutation; CD79A/B Gene Mutation; Ibrutinib; Rituximab

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  The ORR includes complete response and partial response. The treatment response assessments are as follows: Evaluation of treatment response are performed every 2 cycles followed the International Lymphoma Collaborative Group guidelines.

  24 months after the last patient's enrollment

Secondary Outcomes (5)

• Progression Free Survival (PFS)

  at 6 month and 1 year

• Overall Survival (OS)

  at 6 month and 1 year

• Event Free Survival (EFS)

  at 6 month and 1 year

• Adverse events

  24 months after the last patient's enrollment

• Assessment of the correlation between MYD88 and/or CD79A/B or other gene abnormality and efficacy.

  24 months after the last patient's enrollment

Study Arms (1)

Ibrutinib Combined With Rituximab

EXPERIMENTAL

Induction therapy: Ibrutinib 560mg administered oral once a day of each 21-day cycle for 6 cycles. Rituximab 375mg/m² administered intravenously (IV) on Day 1 of each 21-day cycle for 6 cycles. Maintenance therapy: Ibrutinib 560mg administered oral once a day of each 56-day cycle for 6 cycles. Rituximab 375mg/m² administered intravenously (IV) on Day 1 of each 56-day cycle for 6 cycles.

Drug: Ibrutinib Combined With Rituximab

Interventions

Ibrutinib Combined With Rituximab DRUG

Drug: ibrutinib ibrutinib 560mg administered orally once daily. Other Name: Imbruvica Drug: rituximab rituximab 375mg/m² administered intravenously (IV)

Also known as: Imbruvica Combined With Rituximab

Ibrutinib Combined With Rituximab

Eligibility Criteria

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

You may qualify if:

• Participants must be able to understand and be willing to sign a written informed consent document;
• Men and woman who are at least 18 years of age on the day of consenting to the study;
• According to the WHO 2016 classification criteria, pathologically confirmed CD20+diffuse large B-cell lymphoma;
• Patients with MYD88 and CD79A/B mutations or CD79B alone;
• Relapse or progression after treatment with at least two prior therapies;
• There is at least one measurable lesion, defined as a two-path measurable, intraductal lesion short neck \>1.5cm, extranodal lesion short diameter \>1.0cm;
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Blood routine examination meets the following criteria:
• Neutrophil count ≥ 1.0 x 109 / L; Platelet ≥ 75 x 109 / L; Hemoglobin ≥ 10.0 g / dL;
• The main organ function meets the following criteria:
• Aspartate aminotransferase and alanine aminotransferase ≤ 2.0 times the upper limit of normal value; Bilirubin ≤ 2.0 mg / dL; Creatinine clearance rate ≥ 60 mL / min;
• Must agree to effective contraception

You may not qualify if:

• Transformed diffuse large B-cell lymphoma;
• HBV DNA positive or HCV RNA positive;
• Patient is known to have an uncontrolled active systemic infection;
• Left ventricular ejection fraction \< 40%;
• Previous autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, dry syndrome, ankylosing spondylitis, etc;
• Immunosuppressive drugs are being or have been used in the past;
• Known hypersensitivity to the study drug or any of its excipients;
• There are other active malignant tumors that may interfere with this study requiring treatment;
• Known history of human immunodeficiency virus (HIV) infection;
• Previous autologous stem cell transplantation or allogeneic hematopoietic stem cell transplantation;
• The investigator judges that the patient has other inappropriate circumstances.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Recurrence; Lymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yuankai Shi, M.D.

  Cancer Hospital Chinese Academy of Medical Sciences & Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuankai Shi, M.D.

CONTACT

86 010-87788293; syuankaipumc@126.com

Yan Qin, M.D.

CONTACT

86 13601282738; qinyan66@vip.sina.com

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: August 3, 2021
• First Posted: August 6, 2021
• Study Start: October 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2025
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share