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

Primary Purpose

Primary Central Nervous System Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
R-MT followed by auto-HSCT
Sponsored by
Jun Zhu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Central Nervous System Lymphoma focused on measuring Primary central nervous system lymphoma, rituximab, Methotrexate and Temozolomide, autologous stem cell transplantation, Carmustine and thiotepa

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lijuan DengRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R-MT followed by auto-HSCT

Arm Description

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

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

overall response rate
overall survival
event-free survival

Full Information

First Posted
March 1, 2015
Last Updated
April 10, 2015
Sponsor
Jun Zhu
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1. Study Identification

Unique Protocol Identification Number
NCT02399189
Brief Title
MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma
Official Title
MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jun Zhu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Central Nervous System Lymphoma
Keywords
Primary central nervous system lymphoma, rituximab, Methotrexate and Temozolomide, autologous stem cell transplantation, Carmustine and thiotepa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
R-MT followed by auto-HSCT
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
R-MT followed by auto-HSCT
Other Intervention Name(s)
Methotrexate(M), Temozolomide(T), Rituximab(R)
Intervention Description
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.
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall response rate
Time Frame
2 years
Title
overall survival
Time Frame
2 years
Title
event-free survival
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
neurotoxicity
Description
using a battery of cognitive and quality-of-life (QoL) measures
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lijuan deng, MD
Phone
1099196109
Email
lijuan_deng@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuqin Song, MD
Phone
1088196109
Email
songyuqin622@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhu, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Lijuan Deng
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijuan Deng, MD
Phone
1088196109
Email
lijuan_deng@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yuqin Song, MD
Phone
1088196109
Email
songyuqin622@sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
17284616
Citation
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.
Results Reference
result

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

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