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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022839-11 |
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| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
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The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sequential |
|
| 2 | Experimental | Combination |
|
| 3 Brentuximab vedotin/CH-P | Experimental | Combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brentuximab vedotin | Drug | 1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and laboratory abnormalities | Through 1 month after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Brentuximab vedotin concentration in blood | Through 1 month after last dose | |
| Antitherapeutic antibodies in blood | Through 1 month after last dose | |
| Best clinical response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Kennedy, PharmD, BCOP | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | United States | ||
| City of Hope National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25135998 | Result | Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. J Clin Oncol. 2014 Oct 1;32(28):3137-43. doi: 10.1200/JCO.2013.54.2456. Epub 2014 Aug 18. | |
| 29507077 |
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| cyclophosphamide | Drug | 750 mg/m2 IV every 3 weeks (Cycles 3-8) |
|
| brentuximab vedotin | Drug | 1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16) |
|
|
| prednisone | Drug | 100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8) |
|
| cyclophosphamide | Drug | 750 mg/m2 IV every 3 weeks (Cycles 1-6) |
|
| doxorubicin | Drug | 50 mg/m2 IV every 3 weeks (Cycles 3-8) |
|
| doxorubicin | Drug | 50 mg/m2 IV every 3 weeks (Cycles 1-6) |
|
| prednisone | Drug | 100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6) |
|
| vincristine | Drug | 1.4 mg/m2 IV every 3 weeks (Cycles 3-8) |
|
| Through 1 month after last dose |
| Progression-free survival | Until disease progression or study closure |
| Overall survival | Every 3 months until death or study closure |
| Duarte |
| California |
| 91010 |
| United States |
| Stanford Cancer Center | Stanford | California | 94305 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| St. Francis Hospital | Greenville | South Carolina | 29601 | United States |
| MD Anderson Cancer Center / University of Texas | Houston | Texas | 77030-4000 | United States |
| Seattle Cancer Care Alliance / University of Washington Medical Center | Seattle | Washington | 98109 | United States |
| Christie Hospital NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Uttarwar M, Lee SY, Ren H, Kennedy DA, Shustov AR. Five-year outcomes for frontline brentuximab vedotin with CHP for CD30-expressing peripheral T-cell lymphomas. Blood. 2018 May 10;131(19):2120-2124. doi: 10.1182/blood-2017-12-821009. Epub 2018 Mar 5. |
| ID | Term |
|---|---|
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D008223 | Lymphoma |
| D016399 | Lymphoma, T-Cell |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| D003520 | Cyclophosphamide |
| D011241 | Prednisone |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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