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Phase II study for safety and efficacy of BEB (Bendamustine, Etoposide, Busulfan) conditioning regimen for ASCT in non-Hodgkin's lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Busulfan, Etoposide, Bendamustine | Experimental | All patients will receive the conditioning regimen followed by autologous stem cell transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Busulfan | Drug | Busulfan 0.8 mg/kg four times per day from day -7 to day -5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 1 year after ASCT | |
| Progression-free survival | 3 years after ASCT |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 1 year and 3 year after ASCT | |
| Complete response rate | 1 year and 3 year after ASCT | |
| Incidence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieon Lee | Contact | +82-51-240-7053 | jieon@pnuh.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hojin Shin | Pusan National Universty Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Recruiting | Busan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21816830 | Background | Visani G, Malerba L, Stefani PM, Capria S, Galieni P, Gaudio F, Specchia G, Meloni G, Gherlinzoni F, Giardini C, Falcioni S, Cuberli F, Gobbi M, Sarina B, Santoro A, Ferrara F, Rocchi M, Ocio EM, Caballero MD, Isidori A. BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients. Blood. 2011 Sep 22;118(12):3419-25. doi: 10.1182/blood-2011-04-351924. Epub 2011 Aug 3. | |
| 24432893 |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| D005047 | Etoposide |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Etoposide | Drug | Etoposide 400 mg/m2 from day -5 to day -4 |
|
| Bendamustine | Drug | Bendamustine 200 mg/m2 starting dose on day -3 and -2 |
|
| 1 year and 3 year after ASCT |
| Background |
| Shin HJ, Lee WS, Lee HS, Kim H, Lee GW, Song MK, Kim JS, Yhim HY, Chung JS. Busulfan-containing conditioning regimens are optimal preparative regimens for autologous stem cell transplant in patients with diffuse large B-cell lymphoma. Leuk Lymphoma. 2014 Nov;55(11):2490-6. doi: 10.3109/10428194.2014.882504. Epub 2014 Mar 7. |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |