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

Jun Zhu

Status and phase: Unknown; Phase 2

Conditions: Primary Central Nervous System Lymphoma

Treatments: Drug: R-MT followed by auto-HSCT

Study type: Interventional

Funder types: Other

Identifiers

NCT02399189

20150301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

R-MT followed by auto-HSCT

Experimental group

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

Treatment:

Drug: R-MT followed by auto-HSCT