Orelabrutinib in Combination With R2 Regimen for R/R CD20+ B-cell Lymphoma

NCT05014100 | Unknown Phase 2

• 1 other identifier: PYOFGHhema001
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

Obrutinib is a highly selective BTKi and has shown efficacy in CLL/MCL. This study aims to investigate the initial efficacy and safety of obrutinib combined with R2 regimen in the treatment of relapsed or refractory CD20+B cell lymphoma

Conditions

B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  The proportion of patients receiving a OR2 regimens who are in remission

  Enrollment to the last patient complete 6cycles（each cycle is 28 days）, an average of 1 year

Study Arms (1)

The treatment group

EXPERIMENTAL

Orelabrutinib 150mg once daily in a 28-day cycle. Lenalidomide 25mg once daily for 21 days and rituximab 375mg/m2 for 7 days

Drug: Orelabrutinib tablet; Drug: Lenalidomide

Interventions

Orelabrutinib tablet DRUG

Subjects received orelabrutinib150mg orally once daily for a 28-day cycle. Throughout the study period, all subjects continued treatment until one of the following conditions occurred: disease progression, intolerable toxicity, death, withdrawal of informed consent, or loss of follow-up

The treatment group

Lenalidomide DRUG

Lenalidomide 25mg once daily for 21 days and rituximab 375mg/m2 for 7 days Throughout the study period, all subjects continued treatment until one of the following conditions occurred: disease progression, intolerable toxicity, death, withdrawal of informed consent, or loss of follow-up

Also known as: RR

The treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age ≥18 years old, ≤75 years old, gender is not limited;
• \) CD20+B cell lymphoma was confirmed by histopathology, with at least one intranode lesion larger than 1.5CM in length and extranodal lesion larger than 1.0CM in diameter.
• \) Patients with recurrent or refractory CD20+ B-cell lymphoma who have previously received ≥1 line and ≤5 line of different chemotherapy and/or targeted drug therapy failure and lack effective and standard treatment options;
• \) ECOG strength score 0-2;
• \) Medical records that have failed to respond to the latest systematic treatment (not reaching CR/PR) or disease progression after remission;
• \) Major organ functions meet the following criteria:
• A) Blood routine: neutrophils absolute value ≥1.5×109/L, platelets ≥75×109/L, hemoglobin ≥75g/L; Absolute neutrophils if associated with bone marrow invasion
• ≥1.0×109/L, platelet ≥50×109/L, hemoglobin ≥75g/L;
• B) Blood biochemistry: total bilirubin ≤1.5 times ULN, AST or ALT≤3 times ULN; Serum creatinine ≤1.5 ULN; Serum amylase ≤ULN;
• C) Coagulation function: International standardized ratio (INR) ≤1.5 times ULN.
• \) Expected survival ≥3 months;
• \) Voluntarily sign written informed consent before screening.

You may not qualify if:

• \) Current or previous malignancy, unless radical therapy has been performed and there is no evidence of recurrence or metastasis in the past 5 years;
• \) Non-hematologic toxicity of previous antitumor therapy did not return to ≤ grade 1 (excluding hair loss)
• \) Have uncontrolled or significant cardiovascular disease
• \) Had active bleeding within 2 months prior to screening, or was taking anticoagulant drugs, or was considered by the investigator to have a clear tendency to bleeding;
• (8) Urine protein ≥2+, and 24 h urine protein quantification ≥ 2G /24 h;
• \) History of deep vein thrombosis or pulmonary embolism;
• \) The toxicity of the pre-screening treatment regimen has not recovered, and there are still toxicity reactions above grade 1;
• \) Subjects with clinically significant gastrointestinal abnormalities that may affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy;
• \) A history of organ transplantation or allogeneic bone marrow transplantation;
• \) Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive results by POLYMERase chain reaction \[PCR\]).
• \) Current subjects with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function;
• \) Suitable and ready for stem cell transplantation;
• \) Any mental or cognitive impairment that may limit his/her understanding, implementation and compliance with the informed consent;
• \) Subjects with drug and alcohol abuse;
• \) Pregnant and lactating women and subjects of childbearing age who do not want to take contraceptive measures;

Sponsors & Collaborators

• Puyang Oilfield General Hospital: lead

Related Publications (4)

• Ujjani C, Wang H, Skarbnik A, Trivedi N, Ramzi P, Khan N, Cheson BD. A phase 1 study of lenalidomide and ibrutinib in combination with rituximab in relapsed and refractory CLL. Blood Adv. 2018 Apr 10;2(7):762-768. doi: 10.1182/bloodadvances.2017015263.

  PMID: 29610115 BACKGROUND

• Ujjani CS, Jung SH, Pitcher B, Martin P, Park SI, Blum KA, Smith SM, Czuczman M, Davids MS, Levine E, Lewis LD, Smith SE, Bartlett NL, Leonard JP, Cheson BD. Phase 1 trial of rituximab, lenalidomide, and ibrutinib in previously untreated follicular lymphoma: Alliance A051103. Blood. 2016 Nov 24;128(21):2510-2516. doi: 10.1182/blood-2016-06-718106. Epub 2016 Oct 3.

  PMID: 27697771 BACKGROUND

• Goy A, Ramchandren R, Ghosh N, Munoz J, Morgan DS, Dang NH, Knapp M, Delioukina M, Kingsley E, Ping J, Beaupre DM, Neuenburg JK, Ruan J. Ibrutinib plus lenalidomide and rituximab has promising activity in relapsed/refractory non-germinal center B-cell-like DLBCL. Blood. 2019 Sep 26;134(13):1024-1036. doi: 10.1182/blood.2018891598. Epub 2019 Jul 22.

  PMID: 31331917 BACKGROUND

• Yu H, Wang X, Li J, Ye Y, Wang D, Fang W, Mi L, Ding N, Wang X, Song Y, Zhu J. Addition of BTK inhibitor orelabrutinib to rituximab improved anti-tumor effects in B cell lymphoma. Mol Ther Oncolytics. 2021 Apr 3;21:158-170. doi: 10.1016/j.omto.2021.03.015. eCollection 2021 Jun 25.

  PMID: 33981831 BACKGROUND

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

orelabrutinib; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xuejun Guo, PHD

  Puyang Oilfield General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuejun Guo, PHD

CONTACT

+86 13903930612; pygxj@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 20, 2021
• Study Start: September 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2023
• Last Updated: August 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share