Lenalidomide maintenance for patients with primary CNS lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves 28 patients with primary central nervous system diffuse large B-cell lymphoma (PCNSL) who are not eligible for autologous stem cell transplantation or whole brain radiation therapy. After receiving induction treatment with Rituximab and high-dose methotrexate, patients who achieve a complete or partial response will receive lenalidomide maintenance therapy for up to 12 cycles. The maintenance therapy will start six weeks after the last dose of induction chemotherapy, with response evaluations conducted via MRI every three months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. PCNSL patients whose achieved response (CR/PR) after first line immunochemotherapy treatment
2. histology confirmed to be PCNSL
3. ECOG \< 3
4. Hematology values must be within the following limits:

   Absolute neutrophil count (ANC) ≥ 1000/µl Platelets ≥75,000/µl
5. Biochemical values within the following limits:

   Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) Total bilirubin ≤ 2.0 x ULN Creatinine clearance (CrCl) of greater than or equal to 30 mL/min.
6. Females of childbearing potential\* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within24 hours prior to prescribing lenalidomide for Cycle 1 and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide.

   \*A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months).
7. Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy.
8. Patient must understand and voluntarily sign an informed consent form, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

1. Pregnant or breastfeeding females.
2. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
3. Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics.
4. Patients with extra-central nervous system lymphoma
5. Patients who were previously exposed and who developed adverse events, hypersensitivity or desquamating rash to lenalidomide
6. prior cancer history

Where it's running

• Seoul National University Bundang Hospital
  Seongnam-si, Please Select, South Korea Recruiting

Study contacts

• Study coordinator: Jeong-Ok S Lee
• Email: jeongok77@gmail.com
• Phone: +82317878226

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.