Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

Last updated: April 18, 2022
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoma

Treatment

N/A

Clinical Study ID

NCT05334238
PCNSL-001
  • Ages 18-65
  • All Genders

Study Summary

A multicenter, randomized, prospective clinical study of the efficacy and safety of Orelabrutinib maintenance therapy after Autologous Stem Cell Transplantation (ASCT) in patients with primary central nervous system lymphoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men and women, aged 18-65;
  2. Primary CNS lymphoma patients with CR were evaluated in the final stage of first-linetherapy, and the virus-infected patients were balanced between the experimental andcontrol groups;
  3. Laboratory tests (blood routine, liver and kidney function) meet the followingrequirements: A) Blood routine examination: white blood cell count ≥3.0×109/L, absolute neutrophilcount ≥1.5×10^9/L, hemoglobin ≥90g/L, platelet ≥75×10^9/L; B) Liver function:transaminase ≤2.5× upper limit of normal value, bilirubin ≤1.5× upper limit of normalvalue; C) Renal function: serum creatinine 44-133 mmol/L;
  4. Participants' ECOG physical status score was 0-2; The subject or his/her legalrepresentative must provide written informed consent prior to conducting a specialstudy examination or procedure.

Exclusion

Exclusion Criteria: Presence of any of the following criteria will exclude a patient from enrollment:

  • Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders,connective tissue diseases, serious infectious diseases and other diseases
  • Laboratory measures meet the following criteria at screening (unless caused bylymphoma):
  1. Neutrophils<1.5×10^9/L
  2. Platelets<80×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement)
  3. ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP andbilirubin are 1.5 times higher than the ULN.
  4. Creatinine is 1.5 times higher than the ULN or eGFR is lower than 40ml/min/1.73m^2 (according to Cockcroft-Gault Equation or MDRD Equation).
  • HIV-infected patients
  • Left ventricular ejection fraction<50%
  • Patients with HbsAg positive are required to have HBV DNA<1.0×10^3 IU/ml beforeentering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA<1.0×10^3IU/ml is required before entering the group.
  • Other anti-tumor treatments (lymphoma or other types of tumors) are currently inprogress.
  • Patients with psychiatric disorders or patients who are known or suspected to beunable to fully comply with the study protocol
  • History of stroke or intracranial hemorrhage within 6 months prior to start of therapy
  • Inability to swallow capsules or presence of diseases that significantly affectgastrointestinal function, such as malabsorption syndrome, post-bariatric surgery,inflammatory bowel disease and complete or incomplete intestinal obstruction
  • Other medical conditions determined by the researchers that may affect the study

Study Design

Total Participants: 174
Study Start date:
December 01, 2021
Estimated Completion Date:
May 30, 2025

Study Description

This trial was designed as a multicenter, randomized controlled, prospective clinical study. To evaluate the efficacy and safety of Orelabrutinib maintenance therapy with ASCT in patients with primary lymphoma of the central nervous system in a prospective clinical study.

174 patients were enrolled in this study, and randomly divided into Orelabrutinib maintenance group experimental group or observation group (control group) by 1:1. The trial included a screening period (day -28 to day -1), a treatment period (oral administration of Orelabrutinib 150mg daily for 1 year, beginning 8 weeks after autologous transplantation), and a follow-up period (1 year after the end of the last treatment).

Connect with a study center

  • Ruijin Hospital

    Shanghai, Shanghai 20025
    China

    Active - Recruiting

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