Drugs / Campath
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | LEMTRADA | — | 2007-09-19 – 2018-11-28 | fda.gov ↗ |
| Approved | US (FDA) | LEMTRADA | — | 2001-05-07 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00684255 | Aug 2007 → Jul 2008 | systemic lupus erythematosus, systemic sclerosis | New York Medical College | Terminated | No outcome recorded |
| Phase 1 | NCT00113048 | Dec 2003 → Sep 2005 | hematopoietic and lymphoid cell neoplasm | Genzyme, a Sanofi Company | Terminated | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00579111 | Jun 2007 → Feb 2009 | acute lymphoblastic leukemia, acute myeloid leukemia, chronic myeloid leukemia, lymphoproliferative syndrome +2 | Baylor College of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00047060 | Jul 2002 → Jan 2019 | Sezary syndrome, mycosis fungoides | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT01030900 | Oct 2009 → Aug 2021 | Hodgkins lymphoma, diffuse large B-cell lymphoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00462332 | May 2007 → Jun 2011 | leukemia | GIMEMA Foundation | Completed | No outcome recorded |
| Phase 2 | NCT00416884 | May 2003 → Mar 2008 | leukemia | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00683046 | Nov 2001 → Dec 2014 | Hodgkins lymphoma, acute myeloid leukemia, aplastic anemia, chronic lymphocytic leukemia/small lymphocytic lymphoma +2 | University of Chicago | Completed | No outcome recorded |
| Phase 2 | NCT00004143 | Sep 1999 → May 2008 | paroxysmal nocturnal hemoglobinuria, pure red-cell aplasia, sickle cell disease | David Rizzieri, MD | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00176852 | Jun 2002 → Mar 2014 | Diamond-Blackfan anemia, Shwachman-Diamond syndrome, severe congenital neutropenia, sickle cell disease +1 | Masonic Cancer Center, University of Minnesota | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00587847 | Aug 2005 → Nov 2009 | B-cell chronic lymphocytic leukemia | Northwell Health | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT07015684 Background | Apr 2025 → Mar 2030 expected | sickle cell disease | Columbia University | Recruiting | No outcome recorded |
| Phase 1 | NCT00943293 Background | May 2003 → Sep 2011 | graft versus host disease, myeloproliferative neoplasm, plasma cell myeloma, premalignant hematological system disease | University of Chicago | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00943319 Background | Mar 2012 → Dec 2017 | leukemia, plasma cell myeloma | University of Chicago | Completed | No outcome recorded |
| Phase 2 | NCT00578903 Background | Feb 2002 → Jul 2012 | aplastic anemia | Baylor College of Medicine | Terminated | No outcome recorded |
| Phase 3 | NCT00564512 Comparator | Nov 2007 → Jan 2009 | leukemia | French Innovative Leukemia Organisation | Completed | No outcome recorded |
| Phase 4 | NCT00246129 Comparator | Oct 2005 → Jun 2011 | kidney failure | EMagnusson | Completed | Missed primary |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Campath | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00587847 ↗ |
| Known as | alemtuzumab | “This is an open-label, single arm, proof-of-principle study of Campath (also known as alemtuzumab) maintenance therapy administered subcutaneously at varying intervals for up to 1 year.” NCT00587847 ↗1“CAMPATH (alemtuzumab)” NCT00113048 ↗ |
| Known as | Campath-1H | “In addition, a monoclonal antibody called Campath-1H will be given to target lymphocytes, including those that have become cancerous.” NCT00047060 ↗ |
| Action | Deplete | “lymphopenia (reduced lymphocyte counts in the blood) after Campath administration” NCT00246129 ↗ |
| Modality | Monoclonal antibody | “a monoclonal antibody called Campath-1H” NCT00047060 ↗ |
| Route | Intravenous | “alemtuzumab 30mg iv three times a week for two weeks” NCT00047060 ↗ |
| Target | CD52 | “anti-CD52 antibody Campath-1H” NCT00246129 ↗ |