NB02 (Poseltinib) Combined Rituximab and Lenalidomide in R/R PCNSL
ConditionPrimary CNS Lymphoma (PCNSL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-80
SponsorNOBO Medicine
About this trial
An Open, Single treatment arm, Multi-center, Prospective, Phase 2 Trial to Evaluate Efficacy and Safety of NB02 (Poseltinib) combined with Rituximab and Lenalidomide as a Salvage Therapy for Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A patient who voluntarily decided to participate and provided written consent after receiving an explanation of this clinical trial and the characteristics of the investigational drug.
Adults aged 19 years or older and 80 years or younger.
Patients diagnosed histopathologically with CD20-positive primary central nervous system lymphoma (PCNSL).
Patients with confirmed disease progression or treatment resistance after remission induction therapy, radiotherapy, or autologous transplantation, with no more than two prior systemic treatments and no more than one prior radiotherapy treatment (preconditioning and transplantation for hematopoietic stem cells are counted as one systemic treatment; radiotherapy, regardless of fractionation or dose, including concurrent chemoradiotherapy, is counted as one treatment).
Disqualifiers
Patients newly diagnosed with primary central nervous system lymphoma (PCNSL).
Patients with ocular lymphoma without brain lesions.
Patients with metastatic CNS lymphoma involving organs outside the central nervous system, except th eeyes and cerebrospinal fluid (if systemic disease is present: Secondary CNS lymphoma).
Patients with cardiovascular, hepatic, renal, neurological, immune, infectious, or psychiatric disorders that could affect safety, trial evaluation, or protocol compliance (e.g., regular visits).
Trial design
Design model
Single group
Treatments tested in this trial
R2P -> RP
DrugInduction(R2P) 21 days per cycles, 6 cycles * NB02 : 60mg BID PO, Day 1-21 * Rituximab 375mg/m2 DAY IV Day 1, 8, 15 at 1st cycle; D1 at 2nd to 6th cycles * Lenalidomide : 20mg QD PO, Day 1-14 Maintenance(RP) 21 days per cycles, until Progression * NB02 : 60mg BID PO, Day 1-21 * Lenalidomide : 20mg QD PO, Day 1-14
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: NB02 (Poseltinib) combined Rituximab and LenalidomideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall Response (ORR) by IRC
End Of Induction
Time frame
4 cycles (12 weeks)Secondary outcomes
1
Overall Response by Investigator (ORR)
End Of Induction
Time frame
4 cycles (12 weeks)2
Overall Survival (OS)
End of Study
Time frame
through study completion, an estimation of 2 years3
Progression Free Survival (PFS)
End Of Treatment
Time frame
through study completion, an estimation of 2 years4
Event Free Survival (EFS)
End Of Study
Time frame
through study completion, an estimation of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov