A Phase 2 interventional study of Thiotepa in conditioning before transplantation in Central Nervous System Lymphoma, sponsored by Seoul National University Hospital. Terminated at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Seoul National University Hospital · Phase 2, Interventional, and Treatment
The involvement of the central nervous system (CNS) by non-Hodgkin lymphoma (NHL) has carried a poor prognosis. For both of primary central nervous system lymphoma (PCNSL) and secondary central nervous system lymphoma (SCNSL), high-dose methotrexate (HD- MTX) based chemotherapy and combined modality have significantly improved the previously poor response rates and prognosis. However, in PCNSL, relapse rates have remained high, with only 20% to 30% patients achieving a durable long-term remission after HD-MTX. The combination with whole-brain radiotherapy (WBRT) has resulted in higher disease-free and overall survival rates, but it has also been associated with severe neurotoxicity. Patients with SCNSL fare the worst, typically succumbing to disease within median 2.5 to 4 months with 1-year survival rates of only 25%.
Because of these dismal outcomes, intensification of the high-dose chemotherapy (HDC)with autologous stem cell transplantation (autoSCT) has been explored for PCNSL and SCNSL as salvage treatment in patients with refractory or relapsed disease, and as consolidation after primary chemotherapy, replacing or preceding WBRT. Thiotepa, busulfan, and cyclophosphamide (TBC) have significant penetration of blood-brain barrier as shown in several pharmacokinetic studies. Thus, combination of these 3 agents was proposed as one high-dose chemotherapy regimen to achieve therapeutic concentrations in the lymphoma tissue in chemotherapy sanctuaries, like cerebrospinal fluid (CSF), meninges and eyes. eyes. Several studies have shown promising results and favorable long-term toxicity profiles with this combination. However, the relatively rarity of this tumor precludes rapid completion of large-scale phase III trial and, therefore, our reliance on the results of well-designed phase II trials is critical. Therefore, we evaluate the efficacy and toxicity of thiotepa, bulsulfan, and cyclophosphamide as a conditioning for autologous stem cell transplantation in patients with PCNSL and SCNSL.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 17 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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∙Patients with histologically confirmed primary central nervous system lymphoma or secondary CNS lymphoma defined as either synchronous CNS involvement of sys- temic NHL or as a site of recurrence in a patient s with a history of systemic NHL
Exclusion Criteria:
Patients with histologically confirmed primary central nervous system lymphoma or secondary CNS lymphoma defined as either synchronous CNS involvement of sys- temic NHL or as a site of recurrence in a patient s with a history of systemic NHL * Patients who achieved remission after first line chemotherapy and/or WBRT, or who experience relapse of PCNSL/SCNLS. * Patients who have not previously received therapy with high high-dose chemotherapy and stem cell transplantatitransplantation. * The performance st atus of the patients should be 2 or less by ECOG performance scale. * Patients should not have major illness or organ failure incompatible with autologous stem cell transplantation.
Drug: Thiotepa in conditioning before transplantation
For patients with ECOG PS 0 or 1 For patients with ECOG PS 0 or 1 and age \< 60 years old, conditioning regimen before autologous stem cell transplantation consists of thiotepa, bulsulfan, and cyclophosphamide from day -9. Beginning on day -9 and through day -7, each patient was treated with thiotepa (200mg/m m2 IV per day). On days -6 to -4, patients received bulsulfan (2.7mg/kg IV over 3 hours per day every). Bulsulfan-related seizure prophylaxis was given with levetriacetam (1500mg loading on day -6, 500mg twice daily on days -5 to -3). On days -3 and -2, cyclophosphamide (60mg/kg IV per day) was given given. Patients with ECOG PS 2 or age ≥ 60 years old received bulsulfan (3.2mg/kg IV over 3 hours per day for 2 days) resulting in 8 days regimen.
Also known as: high-dose CTx with TBC, followed by auto-SCT
Progression-free survival (PFS)
PFS was calculated from the date of transplantation to the date of disease progression or death from any cause. Patients who were alive without relapse or progression were censored at the time of last contact.
Time frame: 1-year PFS
Overall survival (OS)
OS was calculated from the date of transplantation to death from any cause.
Time frame: through study completion, an average of 1 year
Relapse rate
Time frame: through study completion, an average of 1 year
Non-relapse mortality (NRM)
NRM was defined as any death without evidence of relapse.
Time frame: through study completion, an average of 1 year
Toxicity profile
Time frame: through study completion, an average of 1 year
Plan to share: Undecided — not determined
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This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital