- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02399189
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 Contact
- Name: lijuan deng, MD
- Phone Number: 1099196109
- Email: lijuan_deng@hotmail.com
Study Contact Backup
- Name: Yuqin Song, MD
- Phone Number: 1088196109
- Email: songyuqin622@sina.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Lijuan Deng
-
Contact:
- Yuqin Song, MD
- Phone Number: 1088196109
- Email: songyuqin622@sina.com
-
Contact:
- Lijuan Deng, MD
- Phone Number: 1088196109
- Email: lijuan_deng@hotmail.com
-
-
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
16 years to 63 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 |
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:
|
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
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.
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
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Temozolomide
- Methotrexate
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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