DLBCL Germinal Center B-Cell Type Clinical Trial
Official title:
Frontline Selinexor(ATG-010) Plus R-CHOP Therapy for High-risk GCB-subtype Diffuse Large B-Cell Lymphoma
This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study. And the objective is to Evaluate the safety and efficacy of XR-CHOP in High-Risk (IPI 3-5) GCB-subtype DLBCL.The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.
This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study. Enrolled patients will be treated with 6 cycles of R-CHOP (Rituximab 375 mg/m2, cyclophosphamide 750 mg/m2 , doxorubicin 50 mg/m2 IV, vincristine 0.5 mg/kg on day 1, prednisone 100 mg po on days 1-5 in a 21 day cycle) and a fixed dose, 60 mg of selinexor, orally, weekly, each 3 week a cycle. Disease assessment will be made by positron emission tomography computed tomography (PET-CT) or PET- magnetic resonance imaging (MRI) scans (if CT is contraindicated) at screening (within 14 days of Cycle 1 Day 1). The PET-CT or PET-MRI scans (if CT is contraindicated) will be performed on Cycle 3 Day 1 (±1 week) and then every 8 weeks ± 1 week (i.e., Day 1 of odd numbered cycles) until disease progression is confirmed. The CT (or MRI) is allowed at alternating assessment time points (i.e., every 16 weeks, or every other scan) to replace PET if PET cannot be performed for every assessment. Enrolled patients will be treated with 6 cycles of R-CHOP (Rituximab 375 mg/m2, Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 IV, Vincristine 0.5 mg/kg on day 1, Prednisone 100 mg po on days 1-5 in a 21 day cycle) and a fixed dose, 60 mg of selinexor, orally, weekly, each 3 week a cycle. Treatment will continue for six cycles, or until intolerability, inadequate response, disease progression, consent withdrawal, or death, whichever occur first. Two additional Rituximab doses (1 dose/21-day cycle) are permitted at cycles 7 and 8 if prespecified and considered standard of care per local practice. Investigators could prospectively give prespecified local radiotherapy consolidation after chemotherapy to treat a particular bulky disease site (at least 7 cm) or large mass. Additional prophylaxis or supportive care are recommended for better patient management. The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first. ;
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