A Trial to Compare Ibrutinib Versus Lenalidomide in Combination With MRE-chemotherapy for Adult Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL)

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 1, 2020

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2025

Conditions
Recurrent/RefractoryPrimary Central Nervous System Lymphoma (PCNSL)
Interventions
DRUG

Ibrutinib

Ibrutinib 560 mg/day daily (starting dose) between days 4 and 28 of each cycle for six cycles. Then Ibrutinib is continued until disease progression, intolerable toxicity, death or up to two years.

DRUG

Lenalidomide

Oral lenalidomide 25mg/day between days 4 and 24 of each cycle for six cycles. Then lenalidomide is continued until disease progression, intolerable toxicity, death or up to two years.

DRUG

Methotrexate

Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min + 3 g/m2 in 3-hr infusion) on day 1

DRUG

Rituximab

Rituximab 375 mg/m2 conventional infusion on day 1

DRUG

Etoposide

Etoposide 250 mg/m2 over 3 hours on day3

DRUG

PEGylated recombinant human granulocyte colony

PEGylated recombinant human granulocyte colony 100 ug/kg subcutaneous injection on day 5.

Trial Locations (1)

310009

RECRUITING

Department of Hematology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
collaborator

Ruijin Hospital

OTHER

collaborator

The First Affiliated Hospital of Nanchang University

OTHER

collaborator

Fujian Medical University Union Hospital

OTHER

collaborator

RenJi Hospital

OTHER

collaborator

Shanghai Tong Ren Hospital

OTHER

collaborator

Shandong Provincial Hospital

OTHER_GOV

collaborator

Cancer Hospital of Guangxi Medical University

OTHER

collaborator

Sir Run Run Shaw Hospital

OTHER

collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

OTHER

collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

collaborator

Yinzhou Hospital Affiliated to Medical School of Ningbo University

OTHER

collaborator

Zhejiang University

OTHER

lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER