NCT02657785

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
56mo left

Started Sep 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Sep 2010Dec 2030

Study Start

First participant enrolled

September 1, 2010

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

18.3 years

First QC Date

April 23, 2014

Last Update Submit

September 8, 2020

Conditions

Primary Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    3 year Overall survival

    3 year Overall survival

Study Arms (1)

R-IDARAM plus intrathecal chemotherapy

EXPERIMENTAL

Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy

Drug: R-IDARAM plus intrathecal chemotherapy

Interventions

R-IDARAM plus intrathecal chemotherapyDRUG

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

Also known as: R-IDARAM plus intrathecal immuochemotherapy
R-IDARAM plus intrathecal chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

RECRUITING

Study Officials

  • Liren Qian, M.D.

    Navy General Hospital, Beijing

    STUDY CHAIR

Central Study Contacts

Liren Qian, M.D.

CONTACT

+861066957676qlr2007@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 23, 2014

First Posted

January 18, 2016

Study Start

September 1, 2010

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2030

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)