Bruton's Tyrosine Kinase Inhibitor Ibrutinib as Maintenance Treatment in Elderly Patients With Primary CNS Lymphoma
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|ClinicalTrials.gov Identifier: NCT02623010|
Recruitment Status : Recruiting
First Posted : December 7, 2015
Last Update Posted : November 6, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Lymphoma||Drug: Imbruvica||Phase 2|
30 elderly patients age 60-85 with primary CNS DLBCL who will achieve response CR or PR will enter the study protocol maintenance phase.
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.
Maintenance: 28 day cycles of Ibrutinib 560 mg orally once daily until relapse or disease progression or occurrence of limiting toxicities
Evaluation of response:
Radiologic evaluation by MRI will be performed every 3 months. Neurologic status evaluation every 2 months Neurocognitive evaluation every 6 months
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 2016|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: Single arm
Imbruvica (ibrutinib) will be given as maintenance treatment until relapse or toxicity to 30 elderly PCNSL patients after achieving response to first line treatment
Bruton's Tyrosine Kinase Inhibitor Ibrutinib as maintenance treatment in elderly patients with primary CNS lymphoma following first line chemotherapy treatment
- PFS- progression free survival [ Time Frame: 3 years ]Progression free survival
- Overall survival [ Time Frame: 4 years ]Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623010
|Contact: Osnat Bairey, MDemail@example.com|
|Contact: Tali Siegal, MDfirstname.lastname@example.org|
|Petah Tikva, Israel, 494192|
|Contact: Osnat Bairey, MD 972504065471 email@example.com|
|Contact: Tali Siegal, MD 97239377950 firstname.lastname@example.org|
|Principal Investigator:||Osnat Bairey, MD||Senior Hematologist, Rabin Medical Center|