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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02399189

Enrollment

Registered

2015-03-26

Start date

2014-05-31

Completion date

2019-04-30

Last updated

2015-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Central Nervous System Lymphoma

Keywords

Primary central nervous system lymphoma, rituximab, Methotrexate and Temozolomide, autologous stem cell transplantation, Carmustine and thiotepa

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.

Interventions

DRUGR-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
progression-free survival	2 years

Secondary

Measure	Time frame
overall response rate	2 years
overall survival	2 years
event-free survival	2 years

Other

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

Countries

China

Contacts

Primary Contactlijuan deng, MD

lijuan_deng@hotmail.com1099196109

Backup ContactYuqin Song, MD

songyuqin622@sina.com1088196109

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026