Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL.

NCT04627753 | Recruiting Phase 2 DMC

• 1 other identifier: 2019-10-081
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

• After standard treatment of primary central nervous system lymphoma (PCNSL), high-dose methotrexate induction therapy, and consolidation therapy, most patients reach complete remission, but within the first 6 months, 35-60% of patients refractory to treatment or experience relapse during the first treatment.
• The progression-free survival (PFS) period of relapsed patients is 2.2 months (0-29.6 months), and the survival period is reported as 3.5 months (0-29.6 months). After relapse, the majority of patients die within 2-4 months due to neurologic deterioration
• Consolidation therapy after induction therapy includes whole-brain radiation therapy, high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (auto-SCT), and high-dose chemotherapy alone.
• However, the median age of the inducing patient is 65 years, and more than half of the patients who are unable to transplant autologous hematopoietic stem cells (auto-SCT) after induction therapy account for more than half.
• Therefore, we intend to conduct a study to evaluate the efficacy and safety of maintenance therapy for rituximab and lenalidomide as one of the consolidation therapies for patients with primary central nervous system lymphoma (PCNSL).

Conditions

Primary CNS Lymphoma

Outcome Measures

Primary Outcomes (1)

• 1 year progression free survival

  The incidence of tumor progression or death from all causes during the 1-year follow-up period from the first drug administration date.

  12 months

Secondary Outcomes (4)

• 2-year progression free survival

  24 months

• Overall survival

  24 months

• Overall response

  24 months

• Toxicity profiles

  from the date of informed consent signature to 30 days after last drug administration.

Study Arms (1)

Lenalidomide and Rituximab therapy

EXPERIMENTAL

The clinical trial drug is administered in one cycle for 28 days and is administered as follows. Drug : Rituximab It will be administered 375 mg/m² IV infusion Day 1. (Rituximab: up to 6 cycles) Drug : Lenalidomide It will be administred 20 mg PO day 1 -21. The medication is taken for up to 2 years, and if there is no recurrence, it is stopped after 2 years , Or stop when disease progression is confirmed during the administration period.

Drug: Rituximab, lenalidomide

Interventions

Rituximab, lenalidomide DRUG

Maintenance for 2 years

Also known as: Truxima Inj, Lenalid

Lenalidomide and Rituximab therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who have been diagnosed with histopathological primary central nervous system lymphoma and who have completed standard chemotherapy for induction of remission of primary central nervous system lymphoma have reached a complete or partial response.
• Those who are unable to transplant autologous hematopoietic stem cells for the following reasons
• If you are 65 years of age or older or if you are judged to have a weak systemic condition before receiving high-dose chemotherapy
• Refusal of autologous hematopoietic stem cell transplantation after high-dose chemotherapy
• Adequate laboratory functional values
• Absolute neutrophil count ≥ 1000/ul
• Platelet count ≥ 50,000/ul
• Hemoglobin ≥ 9.0 g/dL
• Serum calcium ≤ 12.0mg/dL
• Serum creatinine ≤ 1.5 X UNL
• AST/ALT ≤ 2.5 X UNL
• Total bilirubin ≤ 1.5 X UNL
• Hepatitis B patients with combination of prophylactic antiviral therapy
• ECOG PS 0-2
• Those who can take oral medication

You may not qualify if:

• If autotransplantation is planned after chemotherapy
• Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within six months prior to 1st day of 1st cycle.
• Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents.
• Uncontrolled hepatitis C infection and/or hepatitis B (except for patients with hepatitis B surface antigen \[SAg\] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).
• Known human immunodeficiency (HIV) seropositive
• Those who are unable to take oral medication
• Patients with a history of malignant tumors other than the target diseases except for the following cases
• If the tumor has not been treated for at least 5 years or is disease-free
• Patients at least 1 year after complete resection of basal cell carcinoma / squamous cell carcinoma or successful treatment of cervical epithelial cancer
• Adverse reactions within 30 days prior to screening Severe gastrointestinal bleeding exceeding Grade 2 according to the Common Terms Criteria 4.03 version criteria
• Occurrence of blood clots or embolism within 6 months before starting screening
• Patients with hypersensitivity to THIS DRUG and other ingredients of THIS DRUG (e.g., angioedema, Stevens-Jones syndrome, toxic epidermal necrosis, etc.)
• Patients with seizure disorder requiring medication
• Female patients who are pregnant or lactating.
• Patients with genetic problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption.

Sponsors & Collaborators

• Kim, Seok Jin: lead
• Celltrion: collaborator
• Samyang Biopharmaceuticals Corporation: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135710, South Korea

RECRUITING

MeSH Terms

Interventions

Rituximab; Lenalidomide

Intervention Hierarchy (Ancestors)

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

• Seok Jin Kim, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seok Jin Kim, MD, PhD

CONTACT

82-2-3410-1766; kstwoh@skku.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Division of hematology-oncology, Department of medicine

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 13, 2020
• Study Start: November 2, 2020
• Primary Completion (Estimated): November 2, 2028
• Study Completion (Estimated): November 2, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

KR (1)