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The goal of this single-arm, prospective study is to learn if high dose gemcitabine, busulfan and thiotepa with autologous stem cell transplantation to treat primary or relapse central nervous system lymphomas. It will learn about the safety and efficacy of combination therapy. The main question it aims to answer is:
Efficacy and safety of the combination of high dose gemcitabine, busulfan and thiotepa as a bridging therapy to ASCT in patients with CNSL.
Participants will:
Take gemcitabine (2.5 g/m²) was administered intravenously (IV) on Days -9 and -3, Busulfan (3.2 mg/kg) was given IV over 3 hours on Days -9 to -7, and thiotepa (5 mg/kg) was administered IV on Days -5, -4, and -3. Peripheral stem cells were infused on Day 0.
Visit the clinic for checkups and tests in accordance with the International Primary CNS Lymphoma Group (IPCG).
Researchers will observe the patients receiving GemBuTT regimen as conditioning therapy in CNSL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine, busulfan and thiotepa as conditioning therapy | Experimental | Gemcitabine (2.5 g/m²) (Days -9 and -3), Busulfan (3.2 mg/kg) (Days -9 to -7), and Thiotepa (5 mg/kg) (Days -5, -4, and -3) were all administered intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy | Drug | Gemcitabine (2.5 g/m²) (Days -9 and -3), Busulfan (3.2 mg/kg) (Days -9 to -7), and Thiotepa (5 mg/kg) (Days -5, -4, and -3) were all administered intravenously. Peripheral stem cells were infused on Day 0. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | The time from stem-cell reinfusion to disease progression, relapse, or death from any cause | 2 years from ASCT |
| Measure | Description | Time Frame |
|---|---|---|
| OS | The time from ASCT to death from any cause | 2 years post ASCT |
| non-relapse mortality (NRM) | NRM was defined as death without evidence of relapse or progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Ji, MD | Contact | 86-28-85422373 | jieji@scu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002066 | Busulfan |
| D013852 | Thiotepa |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| 100 days |
| Hematopoietic recovery | Neutrophil recovery was defined as the first of three consecutive days with an absolute neutrophil count (CAN) ≥ 500/μL (0.5×109/L) after ASCT. Platelet recovery was defined as the first of three consecutive days with a platelet count ≥ 20 000/μL (20 ×109/L) without platelet transfusion for seven consecutive days. | 30 days |
| Non-hematological adverse events (AEs) | 2 months |
| Lymphoma relapse or progression | Relapse or progression was defined as lymphoma progression following ACST | 2 years |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |