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| Name | Class |
|---|---|
| Consortium for Improving Survival of Lymphoma | OTHER |
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The purpose of this study is to determine whether bortezomib, cytarabine, and dexamethasone are effective in the treatment of relapsed or refractory mantle cell lymphoma after 1 to 3 lines of previous treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Bortezomib, Cytarabine, Dexamethasone, Pegteograstim |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib, Cytarabine, Dexamethasone, Pegteograstim | Drug | Bortezomib: 1.3mg/m2 per day, SC (mixed with normal saline 1.4ml) on day 1, 4, 8, and 11 of each 28-day cycle Cytarabine: 1.5g/m2 per day, IV (in the vein) over 3 hours on day 2 and 3 of each 28-day cycle for subjects aged less than 65 and 1g/m2 with the same route and schedule for those aged 65 or older Dexamethasone: 20mg per day, IV (in the vein) or PO on day 1, 4, 8, and 11 of each 28-day cycle Pegfilgrastim: 6mg once, SC on day 13 of each 28-day cycle Number of cycles: 6 unless progression or unacceptable toxicity develops within 6 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response | Lugano classification | within 28 days after the last cycle of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response | Lugano classification | within 28 days after the last cycle of treatment |
| Overall survival | Interval from registration to death from any cause |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | EORTC QLQ-C30 | within 28 days after the last cycle of treatment |
| Toxicity | NCI CTCAE version 4.03 | within 28 days after the last cycle of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Youngil Koh, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25738670 | Background | Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; LYM-3002 Investigators. Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-53. doi: 10.1056/NEJMoa1412096. | |
| 37408333 |
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Demographics, baseline characteristics, response, survival data
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| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D003561 | Cytarabine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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|
|
| 5 years |
| Progression-free survival | Interval from registration to progression or death from any cause | 5 years |
| Shin J, Lee JY, Lee GW, Kim WS, Park Y, Do YR, Kim DS, Kim KH, Choi YS, Byun JM, Hong J, Kim I, Yoon SS, Koh Y. Phase II study of bortezomib, cytarabine and dexamethasone in relapsed or refractory mantle cell lymphoma. Br J Haematol. 2023 Sep;202(6):e54-e57. doi: 10.1111/bjh.18965. Epub 2023 Jul 5. No abstract available. |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |