Health TrialsbyHealthPanel

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

ConditionPrimary CNS Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorKim, Seok Jin

About this trial

* 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Rituximab, lenalidomide

    Drug

    Maintenance for 2 years

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Lenalidomide and Rituximab therapyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

2-year progression free survival

The incidence of tumor progression or death from all causes during the 2-year follow-up period from the first drug administration date.

Time frame
24 months
2

Overall survival

The time from the first drug administration to death from any cause.

Time frame
24 months
3

Overall response

The proportion of patients who achieve complete and partial response.

Time frame
24 months
4

Toxicity profiles

Clinical and laboratory toxicity/symptomatology will be graded based on the NCIC CTG v4.03. Adverse events not reported in NCIC CTG will be categorized into mild, moderate, severe, and fatal and further classified to CTCAE Grades 1-4.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kim, Seok Jin

Lead sponsor

Samsung Medical Center

Sponsor institution

Celltrion

Collaborator

Samyang Biopharmaceuticals Corporation

Collaborator

Source ClinicalTrials.gov
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