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RB/RBAC alternating

Phase 2

Mantle Cell Lymphoma | Small molecule | Oncology |JIN MEDICAL INTERNATIONAL LTD.|Last Updated: Apr 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05245656A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell LymphomaPHASE2 RECRUITING 90Oct 18, 2022Dec 31, 2029Apr 23, 20261 South Korea
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Study Endpoints
Primary Endpoints
Progression-freesurvival
Up to 84 months
Secondary Endpoints
Overall Survival
Up to 84 months
Duration of Response
Up to 84 months
Event Free Survival
Up to 84 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RB/RBAC alternatingEXPERIMENTALEvery 4 weeks for 6 cycles RB (1st, 3rd, and 5th cycles) * Rituximab + Bendamustine RBAC (2nd, 4th, and 6th cycles) * Rituximab + Bendamustine + Cytarabine
RBACTIVE_COMPARATOREvery 4 weeks for 6 cycles \- Rituximab + Bendamustine
Interventions
NameTypeDescription
RB/RBAC alternatingDRUGPatients assigned to the RB alternating with RBAC arm will receive six cycles of alternating RB (odd cycles) or RBAC (even cycles) RB (1st, 3rd, and 5th cycles) * Rituximab 375mg/m2, IV, D1 * Bendamustine 90mg/m2, IV, D1-2 RBAC (2nd, 4th, and 6th cycles) * Rituximab 375mg/m2, IV, D1 * Bendamustine 70mg/m2, IV, D2-3 * Cytarabine 500mg/m2, IV, D2-4
RBDRUGEvery 4 weeks for 6 cycles * Rituximab 375mg/m2, IV, D1 * Bendamustine 90mg/m2, IV, D1-2
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. newly diagnosed, previously untreated, histologically confirmed CD20+ mantle cell lymphoma, confirmed by WHO classification criteria 2. age ≥70 years or 60-69 years if the patients are ineligible for high-dose therapy with autologous stem cell transplantation. 3. ECOG perform...

Countries:South Korea
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05245656studyFirstPostDate: changed