tong Chen
tong Chen
This is a single-arm and open-label study to explore X+MTX+Ritu (ATG-010, Methotrexate, Rituximab) regimen in Relapse refractory PCNSL patients. Approximately 30 patients will be enrolled in the study. In dose escalation phase, patients with Relapse refractory PCNSL will be treated with X+MTX+Ritu regimen and escalating doses of oral ATG-010 weekly in a 3+3 design. Then a phase 2 expansion at the recommended dose level based on phase 1b trial will be conducted to evaluate the efficacy, safety and tolerability.
Central Nervous System Lymphoma
Selinexor
Rituximab
Methotrexate
Phase 1
Phase 2
In dose escalation phase, patients with Relapse refractory PCNSL will be treated with X+MTX+Ritu regimen (Methotrexate 3.5 g/m2, d1; Rituximab 375 mg/m2, d0)and escalating doses of oral ATG-010 weekly in a 3+3 design. ATG-010 dose level (DL) 1, 2 and 3 are 60, 80 and 100mg respectively respectively on day 1,8,15,22 for 28-days cycle. The phase 2 expansion at the recommended dose level based on phase 1b trial. The total 6 cycles, 28 days per cycle . And, Subjects participating in the study will undergo a screening period(up to 21days), a treatment period, and a follow-up period. The screening period is a maximum of 21 days before treatment period, And will be followed by 6 cycles of combination treatment(28 days per cycle). partial remission(PR) patients after induction treatment will continue ATG-010 maintenance up to 1 year or until disease progression, intolerable toxicity, death.}}
Study Type : | Interventional |
Estimated Enrollment : | 30 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Selinexor in Combination With Methotrexate and Rituximab for Relapsed /Refractory Central Nervous System (CNS) Lymphoma |
Actual Study Start Date : | August 3, 2023 |
Estimated Primary Completion Date : | June 30, 2026 |
Estimated Study Completion Date : | December 31, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: X-MTX-Ritu Escalating doses of oral ATG-010 weekly in a 3+3 design. ATG-010 dose level (DL) 1, 2 and 3 are 60, 80 and 100mg respectively respectively on day 1,8,15,22 for 28-days cycle.and the phase 2 expansion at the recommended dose level based on phase 1b trial. And, Methotrexate 3.5 g/m2, d1 and Rituximab 375 mg/m2, d0, 28-days cycle.The total 6 cycles, 28 days per cycle. |
Drug: Selinexor Drug: Rituximab Drug: Methotrexate |
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China, 450052
Not yet recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, China, 200040
Not yet recruiting
The First Affiliated Hospital Of Fujian Medical University
F U axis, Fujian, China,
Not yet recruiting
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China,
Recruiting
Department of Hematology, Huashan Hospital, Fudan University
Shanghai, Shanghai, China,