A single center Phase II study for the safety and efficacy of upfront high dose chemotherapy with thiotepa and busulfan followed by autologous peripheral blood stem cell transplantation for primary central nervous system lymphoma.

A single center Phase II study for the safety and efficacy of upfront high dose chemotherapy with thiotepa and busulfan followed by autologous peripheral blood stem cell transplantation for primary central nervous system lymphoma. - P2 clinical trial of TT/BU with auto-PBSCT for PCNSL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000041182

Enrollment

Registered

2020-08-17

Start date

2020-08-17

Completion date

Unknown

Last updated

2026-06-29

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

Interventions

Busulfan 3.2mg/kg (d-8,-7,-6,-5) Thiotepa 5mg/kg (d-4,-3) ASCT (d0)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with primary CNS lymphoma between 16 and 64 years of age. 2)Participants must sign the informed concent form (ICF). 3)Patients in first complete remission, and who had hematopoietic cells collected for autologous HSCT (CD34-positive cells >= 2x10^6/kg). 4)ECOG PS 0-2. 5)AST and ALT <= threefold, T-Bil and Cre <= 1.5-fold the reference range, left ventricular ejection fraction >= 50%, and eGFR >= 60 mL/min.

Exclusion criteria

Exclusion criteria: 1)Other treatment for the management of underlying disease within 20 days prior to treatment initiation. 2)Patients with previous HSCT within 6 months prior to the study HSCT. 3)Patients with serious hypersensitivity to thiotepa or busulfan. 4)Patients with active infection. 5)Patients with positive test for hepatitis B surface antigen, HBV-DNA, hepatitis C virus antibody, or HIV. 6)Patients with cardiac effusion, pleural effusion, or ascites requiring treatment. 7)Patients with active double cancer. 8)Pregnant or lactating patients. 9)Patients who the investigator or subinvestigator judged as inappropriate for trial entry.

Design outcomes

Primary

Measure	Time frame
1.Safety: adverse event. 2.Efficacy: bone marrow suppression rate, engraftment rate, time to engraftment, and survival rate at Day 100 post-HSCT.	—

Countries

Japan

Contacts

Public ContactHiroshi Kosugi

Ogaki municipal hospital Department of Hematology

h-kosugi@umin.ac.jp0584-81-3341

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026