MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma

April 10, 2015 updated by: Jun Zhu
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It's a single center, single arm, prospective clinical trial. Patients younger than 65 years old with primary central nervous system lymphoma will received four cycles of chemotherapy with rituximab plus high-dose methotrexate and temozolomide as induction therapy, and then received consolidation therapy with autologous stem cell transplant for which the conditioning regimen is Carmustine plus thiotepa.

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R-MT followed by auto-HSCT

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
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.
Other Names:
  • Methotrexate(M)
  • Temozolomide(T)
  • Rituximab(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 2 years
2 years
overall response rate
Time Frame: 2 years
2 years
event-free survival
Time Frame: 2 years
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurotoxicity
Time Frame: 2 years
using a battery of cognitive and quality-of-life (QoL) measures
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jun Zhu

Investigators

  • Study Chair: Jun Zhu, MD, Peking University Cancer Hospital & Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

March 1, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Estimate)

April 13, 2015

Last Update Submitted That Met QC Criteria

April 10, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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