Lenalidomide Maintenance Treatment in Patients With Primary Central Nervous System Lymphoma

Launched by SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL · Feb 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called lenalidomide as a maintenance treatment for patients with primary central nervous system lymphoma (PCNSL) who cannot receive certain standard therapies. The trial will involve 28 patients who have shown some improvement after initial treatment, which includes a combination of chemotherapy drugs. If patients respond well to this initial treatment, they will take lenalidomide daily for 12 cycles, unless they choose to withdraw from the study, experience side effects, or their disease worsens.

To be eligible for this trial, patients must have already received treatment for their PCNSL and achieved a good response. They need to be in generally good health and meet specific blood test requirements. The trial is open to adults of all ages, and both men and women can participate, although women of childbearing age must use effective birth control. Participants can expect regular monitoring and support throughout the study, and they have the option to leave the trial at any time without affecting their future medical care.

Gender

ALL

Eligibility criteria

• 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