Clinical trial NCT02399189: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Primary Central Nervous System Lymphoma
Keywords: Primary central nervous system lymphoma
rituximab
Methotrexate and Temozolomide
autologous stem cell transplantation
Carmustine and thiotepa
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: overall response rate
timeFrame: 2 years
measure: overall survival
timeFrame: 2 years
measure: event-free survival
timeFrame: 2 years
Other outcomes:
measure: neurotoxicity
timeFrame: 2 years
Locations:
city: Beijing
country: China
facility: Lijuan Deng
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu, MD
role: STUDY_CHAIR
References:
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.