Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
Summary
This is a multicenter open label randomized phase II trial.
Enrolled Primary Central Nervous System Lymphoma (PCNSL) patients will be stratified
according to the IELSG score and randomized to receive one of the follows as primary
chemotherapy:
- Arm A: Methotrexate (MTX) + Cytarabine (Ara-C)
- Arm B: MTX + Ara-C + rituximab
- Arm C: MTX + Ara-C + rituximab + thiotepa.
Chemotherapy will be administered every three weeks. The maximum number of chemotherapy
induction courses will be 4. Patients in Stable Disease (SD) or better after two courses will
receive two more courses of the same primary chemotherapy regimen. Stem-cells harvest will be
performed in the three arms after the second course. After 4 courses response assessment will
be performed.
Patients who will not achieve SD or better after the 4th course, as well as those who will
experience Progressive Disease (PD) at any time and those who will not achieve a sufficient
stem cell harvest, will receive Whole Brain Radiation Therapy (WBRT) 36-40 Gy +/- tumor bed
boost of 9 Gy.
Patients who will achieve SD or better after the 4th course will be stratified according to
objective response to primary chemotherapy and to primary chemotherapy regimen and randomly
allocated to receive as consolidation therapy one of the follows:
- Arm D: WBRT 36 Gy +/- boost 9 Gy
- Arm E: Carmustine (BCNU) + Thiotepa + Autologous Peripheral Blood Stem Cell Transplant
(APBSCT) Patients in Complete Response (CR) after WBRT or APBSCT will remain in
follow-up. Patients who will not achieve a CR after WBRT will be managed according to
physician's preferences. Patients who will not achieve a CR after APBSCT will be
referred to WBRT.
Phase:
Phase 2
Details
Lead Sponsor:
International Extranodal Lymphoma Study Group (IELSG)