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

Summary

This is a open-label，multicenter, randomised, three-arm, phase II efficacy and safety study of ibrutinib in combination with MRE(methotrexate,rituximab,etoposide)-chemotherapy versus lenalidomide in combination with MRE-chemotherapy given to adult patients who have recurrent/refractory primary central nervous system lymphoma (PCNSL)

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.

Sponsors & Collaborators

• Ruijin Hospital

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Shanghai Tong Ren Hospital

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Cancer Hospital of Guangxi Medical University

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• Yinzhou Hospital Affiliated to Medical School of Ningbo University

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2023-12-31

Completion

2025-12-31

Countries

• China

Study Locations