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

Primary Central Nervous System Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02399189
• Other study ID #: 20150301
• Status: Recruiting
• Phase: Phase 2
• First received: March 1, 2015
• Last updated: April 10, 2015
• Start date: May 2014
• Est. completion date: April 2019

Study information

• Verified date: April 2015
• Source: Peking University
• Contact: lijuan deng, MD
• Phone: 1099196109
• Email: lijuan_deng[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: April 2019
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma

Intervention

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.

Locations

Country	Name	City	State
China	Lijuan Deng	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jun Zhu

Country where clinical trial is conducted

China, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	neurotoxicity	using a battery of cognitive and quality-of-life (QoL) measures	2 years	Yes
Primary	progression-free survival		2 years	No
Secondary	overall response rate		2 years	No
Secondary	overall survival		2 years	No
Secondary	event-free survival		2 years	Yes