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Ibrutinib With Rituximab and Lenalidomide for Patients With Recurrent/Refractory Primary or Secondary Central Nervous System Lymphoma (PCNSL/SCNSL)

NCT03703167 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-29

No results posted yet for this study

Summary

The investigator's want to find out if treatment with ibrutinib, rituximab, and lenalidomide are safe and better than the usual approach in patients with recurrent or refractory central nervous system lymphoma.

Conditions

  • Primary Central Nervous System Lymphoma (PCNSL)
  • Secondary Central Nervous System Lymphoma (SCNSL)

Interventions

DRUG

Ibrutinib

Oral ibrutinib will be given between days 1 and 28 of each 28-day cycle and will be continued daily after completion of rituximab and lenalidomide. The starting dose of ibrutinib is 560 mg/day (dose level 1) and (dose level 2 ibrutinib: 840 mg daily).

DRUG

Lenalidomide

Oral lenalidomide will be given between days 1 and 21 of each 28-day cycle for a maximum of 12 cycles. The starting dose of lenalidomide is 10 mg/day (dose level 1 \& 2) lenalidomide: 15 mg daily (dose level 3) and lenalidomide: 20 mg daily (dose level 4).

DRUG

Rituximab

Intravenous rituximab (500mg/m2) will be given on day 1 of all cycles (+/- 3 days), for up to 6 cycles.

Sponsors & Collaborators

Principal Investigators

  • Christian Grommes, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-22
Primary Completion
2026-01-26
Completion
2026-01-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03703167 on ClinicalTrials.gov