NCT02399189

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of chemotherapy with MT-R followed by autologous stem cells transplantation in newly-diagnosed primary central nervous system lymphoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

May 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

Enrollment Period

2.9 years

First QC Date

March 1, 2015

Last Update Submit

April 10, 2015

Conditions

Primary Central Nervous System Lymphoma

Keywords

Primary central nervous system lymphomarituximabMethotrexate and Temozolomideautologous stem cell transplantationCarmustine and thiotepa

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    2 years

Secondary Outcomes (3)

  • overall response rate

    2 years

  • overall survival

    2 years

  • event-free survival

    2 years

Other Outcomes (1)

  • neurotoxicity

    2 years

Study Arms (1)

R-MT followed by auto-HSCT

EXPERIMENTAL

R-MT followed by auto-HSCT Rituximab 375 mg/m2 d1 MTX 3.5g/m2 d2(0.5g/m2 15min,3g/m2 3h） TMZ 100 mg/m2 d2-6 Q21d\*4cycles Auto-HSCT conditioning regimen: BCNU 400mg/m2 d1; Thiotepa 5mg/kg q12h，d2-3

Drug: R-MT followed by auto-HSCT

Interventions

R-MT followed by auto-HSCTDRUG

Four cycles of Induction therapy: Rituximab 375mg/m2 d1; Methotrexate 3.5g/m2 d2;Temozolomide 100mg/m2 d2-6; for patients who reach a CR, PR, or SD, will proceed to autologous stem cell transplantation: Carmustine 400mg/m2 d1; Thiotepa 5mg/kg q12h, d2-3.

Also known as: Methotrexate(M), Temozolomide(T), Rituximab(R)
R-MT followed by auto-HSCT

Eligibility Criteria

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

You may qualify if:

  • primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy
  • ECOG 0-2
  • Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan
  • Leucocytes\>3.500/mm3, platelets\>130.000/mm3, Bilirubin \< 2 mg, transaminases \< 2.5 N), creatinine \< 150 μM/l, creatinine clearance \> 50 ml/min/1.73m2
  • Age 18-65 years
  • Negative HIV test
  • Signature of informed consent

You may not qualify if:

  • prior chemotherapy for primary central nervous system lymphoma
  • presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ )
  • systemic lymphoma (outside the CNS)
  • Isolated ocular lymphoma
  • Immunosuppressed patients (HIV , use of immunosuppressors)
  • Other uncontrolled or progressive disease compromising shot-term survival
  • Severe renal or hepatic disease
  • Patients not legally covered by the French Social Security
  • Inability to swallow the medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lijuan Deng

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (1)

  • Correa DD, Maron L, Harder H, Klein M, Armstrong CL, Calabrese P, Bromberg JE, Abrey LE, Batchelor TT, Schiff D. Cognitive functions in primary central nervous system lymphoma: literature review and assessment guidelines. Ann Oncol. 2007 Jul;18(7):1145-51. doi: 10.1093/annonc/mdl464. Epub 2007 Feb 6.

    PMID: 17284616RESULT

Study Officials

  • Jun Zhu, MD

    Peking University Cancer Hospital & Institute

    STUDY CHAIR

Central Study Contacts

lijuan deng, MD

CONTACT

1099196109lijuan_deng@hotmail.com

Yuqin Song, MD

CONTACT

1088196109songyuqin622@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of the department of lymphoma

Study Record Dates

First Submitted

March 1, 2015

First Posted

March 26, 2015

Study Start

May 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2019

Last Updated

April 13, 2015

Record last verified: 2015-04

Locations

CN(1)