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NCT02623010

Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib as Maintenance Treatment in Elderly Patients With Primary CNS Lymphoma Following First Line Chemotherapy Treatment

Status unknown Phase 2 Last updated 9 May 2022
What this trial tests

Phase 2 trial testing Imbruvica in Central Nervous System Lymphoma in 30 participants. Status unknown.

Timeline
1 October 2016
Primary endpoint
1 December 2023
1 December 2023

Quick facts

Lead sponsorRabin Medical Center
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 October 2016
Primary completion1 December 2023
Estimated completion1 December 2023
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Rabin Medical Center

Who can join

Adults 60 to 85, any sex, with Central Nervous System Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The study will include 30 elderly patients age 60-85 with primary CNS DLBCL . Induction treatment will include Rituximab and high dose methotrexate protocol (containing at least methotrexate and one more chemotherapy agent). Patients with MRI documented response CR or PR will enter the study protocol maintenance phase which will include continous treatment with Ibrutinib 560 mg day until relapse or disease progression or occurrence of limiting toxicities

Publications & conference data

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

  1. Primary central nervous system lymphoma.
    Schaff LR, Grommes C. · · 2022 · cited 160× · PMID 34699590 · DOI 10.1182/blood.2020008377
  2. Dysregulation of Cell Survival in Diffuse Large B Cell Lymphoma: Mechanisms and Therapeutic Targets.
    Miao Y, Medeiros LJ, Xu-Monette ZY, Li J, et al · · 2019 · cited 39× · PMID 30881917 · DOI 10.3389/fonc.2019.00107
  3. Current and emerging therapies for primary central nervous system lymphoma.
    Yuan Y, Ding T, Wang S, Chen H, et al · · 2021 · cited 30× · PMID 33957995 · DOI 10.1186/s40364-021-00282-z
  4. Bruton's tyrosine kinase inhibitors in the treatment of primary central nervous system lymphoma: A mini-review.
    Shen J, Liu J. · · 2022 · cited 18× · PMID 36465385 · DOI 10.3389/fonc.2022.1034668
  5. Targeted Therapies and Immune Checkpoint Inhibitors in Primary CNS Lymphoma.
    Wirsching HG, Weller M, Balabanov S, Roth P. · · 2021 · cited 17× · PMID 34203062 · DOI 10.3390/cancers13123073
  6. Primary Central Nervous System Lymphoma in Elderly Patients: Management and Perspectives.
    Morales-Martinez A, Lozano-Sanchez F, Duran-Peña A, Hoang-Xuan K, et al · · 2021 · cited 16× · PMID 34298693 · DOI 10.3390/cancers13143479
  7. Update on Novel Therapeutics for Primary CNS Lymphoma.
    Schaff LR, Grommes C. · · 2021 · cited 15× · PMID 34771535 · DOI 10.3390/cancers13215372
  8. Novel insights into the biomarkers and therapies for primary central nervous system lymphoma.
    Zhai Y, Zhou X, Wang X. · · 2022 · cited 7× · PMID 35558005 · DOI 10.1177/17588359221093745

Verify or expand the search:

Other recruiting trials for Central Nervous System Lymphoma

Currently open trials in the same condition.

Other Rabin Medical Center trials

Trials by the same sponsor.

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Data sources for this page

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