Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL

Primary Central Nervous System Lymphoma Clinical Trial

Official title:

Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With Primary CNS Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02836158
• Other study ID #: NavyGHB-002
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 2010
• Est. completion date: December 2030

Study information

• Verified date: September 2020
• Source: Navy General Hospital, Beijing
• Contact: Liren Qian, M.D.
• Phone: +861066957676
• Email: qlr2007[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in elderly patients with primary central nervous system lymphoma (PCNSL).

Description:

The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in elderly patients with primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).

Exclusion Criteria:

• Involved sites other than the brain, meninges, CSF, or the eyes.

• Age less than 18 years or greater than 75 years.

• Inadequate bone marrow capacity (defined as neutrophils<1.5 ×10^9/L, platelets <100 ×10^9/L, and hemoglobin level< 8 g/dL).

• Known cause of immunosuppression (ie, HIV type I infection).

• Any previous malignancy.

• Creatinine clearance below 60 mL/min.

• Heart insufficiency (NYHA IIIB or IV).

• Uncontrolled infection.

• Noncompensated active pulmonary or liver disease.

• Previously treated for PCNSL, except by corticosteroids.

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma

Intervention

Drug:
• R-IDARAM plus intrathecal chemotherapy
R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2); methotrexate 1.5 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 20mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.

Locations

Country	Name	City	State
China	Navy General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	3 year Overall survival	3 year Overall survival