NCT01542918 is a Phase 1 clinical trial of Lenalidomide in Recurrent/Refractory CNS, sponsored by James Rubenstein.

Who is sponsoring NCT01542918?

NCT01542918 is sponsored by James Rubenstein.

What drugs are being tested in NCT01542918?

Interventions in NCT01542918: Lenalidomide, Rituximab.

What condition does NCT01542918 study?

NCT01542918 studies Recurrent/Refractory CNS, Intraocular Lymphoma.

Is NCT01542918 still recruiting?

NCT01542918 is currently completed. Last updated 11 August 2020.

Last reviewed 2020-08-11 · How we verify

NCT01542918

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Lenalidomide Plus Rituximab for Recurrent/Refractory CNS and Intraocular Lymphoma

Completed Phase 1 Last updated 11 August 2020

What this trial tests

Phase 1 trial testing Lenalidomide in Recurrent/Refractory CNS in 14 participants. Completed in 30 August 2016.

Timeline

17 December 2012

Primary endpoint
7 April 2016

30 August 2016

Quick facts

Lead sponsor	James Rubenstein
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	17 December 2012
Primary completion	7 April 2016
Estimated completion	30 August 2016
Sites	1 location across United States

Drugs / interventions tested

Lenalidomide — full drug profile →
Rituximab — full drug profile →

Conditions studied

Recurrent/Refractory CNS — all drugs for Recurrent/Refractory CNS →
Intraocular Lymphoma — all drugs for Intraocular Lymphoma →

Sponsor

James Rubenstein

Who can join

18 and older, any sex, with Recurrent/Refractory CNS or Intraocular Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase I study, which means that the goal is to see if the study treatment is safe. The purpose of this study is to test the safety of Lenalidomide at different dose levels, and to test the safety of Lenalidomide alone or in combination with Rituximab (also known as Rituxan®).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Phase 1 investigation of lenalidomide/rituximab plus outcomes of lenalidomide maintenance in relapsed CNS lymphoma.
Rubenstein JL, Geng H, Fraser EJ, Formaker P, et al · · 2018 · cited 135× · PMID 29986852 · DOI 10.1182/bloodadvances.2017014845
How I treat CNS lymphomas.
Rubenstein JL, Gupta NK, Mannis GN, Lamarre AK, et al · · 2013 · cited 132× · PMID 23963042 · DOI 10.1182/blood-2013-06-453084
Trial Watch: Lenalidomide-based immunochemotherapy.
Semeraro M, Vacchelli E, Eggermont A, Galon J, et al · · 2013 · cited 46× · PMID 24482747 · DOI 10.4161/onci.26494
Therapy of primary CNS lymphoma: role of intensity, radiation, and novel agents.
Ferreri AJM. · · 2017 · cited 42× · PMID 29222306 · DOI 10.1182/asheducation-2017.1.565
Progress in central nervous system lymphomas.
Wang CC, Carnevale J, Rubenstein JL. · · 2014 · cited 40× · PMID 24837460 · DOI 10.1111/bjh.12938
Beyond high-dose methotrexate and brain radiotherapy: novel targets and agents for primary CNS lymphoma.
Ponzoni M, Issa S, Batchelor TT, Rubenstein JL. · · 2014 · cited 38× · PMID 24265352 · DOI 10.1093/annonc/mdt385
The Challenge of Primary Central Nervous System Lymphoma.
Carnevale J, Rubenstein JL. · · 2016 · cited 33× · PMID 27888882 · DOI 10.1016/j.hoc.2016.07.013
New approaches in primary central nervous system lymphoma.
Fraser E, Gruenberg K, Rubenstein JL. · · 2015 · cited 28× · PMID 25841718 · DOI 10.3978/j.issn.2304-3865.2015.02.01

Verify or expand the search:

Other trials of Lenalidomide

Trials testing the same drug.

NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
NCT07247097 — ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred · Phase 2 · not yet recruiting
NCT07465029 — A Study of Incidence, Treatment Patterns, and Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in · active not recruiting
NCT07261163 — Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma · Phase 2 · not yet recruiting
NCT06910124 — Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Neg · Phase 2 · recruiting

Other James Rubenstein trials

Trials by the same sponsor.

NCT05351593 — Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma · Phase 1, PHASE2 · recruiting
NCT04656431 — Feasibility of Acquiring Hyperpolarized Imaging in Patients With Primary CNS Lymphoma · Phase 1 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01542918 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by James Rubenstein
Last refreshed: 11 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01542918.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing