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Randomized Phase II Trial On Primary Chemotherapy With High-Dose Methotrexate And High-Dose Cytarabine With Or Without Thiotepa, And With Or Without Rituximab, Followed By Brain Irradiation Vs. High-Dose Chemotherapy Supported By Autologous Stem Cells Transplantation For Immunocompetent Patients With Newly Diagnosed Primary CNS Lymphoma


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Central Nervous System Lymphoma

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Trial Information

Randomized Phase II Trial On Primary Chemotherapy With High-Dose Methotrexate And High-Dose Cytarabine With Or Without Thiotepa, And With Or Without Rituximab, Followed By Brain Irradiation Vs. High-Dose Chemotherapy Supported By Autologous Stem Cells Transplantation For Immunocompetent Patients With Newly Diagnosed Primary CNS Lymphoma


Inclusion Criteria:



- Histological or cytological assessed diagnosis of non-Hodgkin's lymphoma.

- Diagnostic sample obtained by stereotactic or surgical biopsy, Cerebrospinal Fluid
(CSF) cytology examination or vitrectomy.

- Disease exclusively localized into the central nervous system, CSF, cranial nerves or
eyes.

- At least one measurable lesion.

- Previously untreated patients (previous or ongoing steroid therapy admitted).

- Age 18-65 years (with ECOG Performance Status 0-3) or 66-70 (with ECOG Performance
Status 0-2).

- Adequate bone marrow, renal, cardiac, and hepatic function.

- Sexually active patients of childbearing potential agreeing in implementing adequate
contraceptive measures during study participation.

- Absence of any familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule.

- Patient-signed informed consent obtained before registration.

Exclusion Criteria:

- Patients with lymphomatous lesions outside the CNS.

- Patients with a previous non-Hodgkin lymphoma at any time.

- Previous or concurrent malignancies with the exception of surgically cured carcinoma
in-situ of the cervix, carcinoma of the skin or other cancers without evidence of
disease at least from 5 years.

- HBsAg and HCV positivity.

- HIV infection, previous organ transplantation or other clinically evident form of
immunodeficiency.

- Concurrent treatment with other experimental drugs.

- Concurrent Pregnancy or lactation.

- Patients not agreeing to take adequate contraceptive measures during the study.

- Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication
or myocardial infarction within the last 6 months (New York Heart Association Class
III or IV heart disease).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate after primary chemotherapy and 2 years failure free survival at second randomization

Outcome Time Frame:

3 months, 2 years

Safety Issue:

No

Principal Investigator

Andrés JM Ferreri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Raffaele H Scientific Institute, Milan, Italy

Authority:

Switzerland: Swissmedic

Study ID:

IELSG32

NCT ID:

NCT01011920

Start Date:

November 2009

Completion Date:

December 2016

Related Keywords:

  • Central Nervous System Lymphoma
  • newly diagnosed primary central nervous system lymphoma
  • Lymphoma

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