Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Apr 1, 2027 → Aug 1, 2027
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 234 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Apr 1, 2027 to Aug 1, 2027
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised at 6 of 56 sites
  2. Enrollment closed, study ongoing
    • Site details revised at 56 of 56 sites
    v233
  3. Site details revised at 1 of 56 sitesv232
  4. Study sites: 55 to 56v231
  5. Site details revised at 1 of 55 sitesv230
Show 22 earlier versionsHide 22 earlier versions
  1. Site contacts updated at 1 of 55 sitesv229
  2. Site details revised at 1 of 55 sitesv228
  3. Site details revised at 1 of 55 sitesv227
  4. Re-verified, no change to tracked fieldsv226
  5. Study sites: 54 to 55v225
  6. Site details revised at 2 of 54 sites
    • Eligibility criteria expanded, about 1 word
    v224
  7. Site details revised at 1 of 54 sitesv223
  8. Site details revised at 1 of 54 sitesv222
  9. Site details revised at 1 of 54 sitesv221
  10. Site contacts updated at 1 of 54 sitesv220
  11. Study sites revised (54)v219
  12. Site contacts updated at 1 of 54 sitesv218
  13. Site details revised at 1 of 54 sitesv217
  14. Site details revised at 1 of 54 sitesv216
  15. Site details revised at 1 of 54 sitesv215
  16. Site contacts updated at 1 of 54 sitesv214
  17. Site details revised at 2 of 54 sitesv213
  18. 5 versions Re-verified since Apr 3, 2026, no change to tracked fieldsv208-v212
  1. Primary and study completion pushed from May 31, 2026 to Apr 1, 2027v207
  2. 22 versions Re-verified since Mar 3, 2026, no change to tracked fieldsv185-v206
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase I trial tests the safety, side effects, best dose and effectiveness of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Methotrexate is frequently combined with other chemotherapy agents to improve response. This study may help increase the understanding of lenalidomide and nivolumab use in primary CNS lymphoma treatment. In addition, it may help researchers see whether the control of CNS lymphoma can be extended by using these study drugs as maintenance (prolonged therapy) after control is achieved with the initial chemotherapy regimen (induction).
Trial Details
NCT Number NCT04609046
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System
Enrollment 47 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov