Drugs / Chlorambucil
Chlorambucil
also known as
Ambochlorin · CB-1348 · Chlorambucil: Leukeran · Chlorambucilum · Clorambucilo · Ecloril · Leukeran · Lympholysin · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | LEUKERAN | — | 1957-03-18 | fda.gov ↗ |
Trials 29 · a red edge is where a trial was stopped
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Also used as a comparator or background therapy in 25 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02336048 Background | Jun 2015 → Sep 2018 | B-cell chronic lymphocytic leukemia | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1 | NCT02100852 Background | Mar 2014 → Nov 2017 | chronic lymphocytic leukemia/small lymphocytic lymphoma | TG Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT01403246 Background | Nov 2011 → Jan 2015 | B-cell chronic lymphocytic leukemia | GIMEMA Foundation | Terminated | No outcome recorded |
| Phase 1/2 | NCT00558961 Background | Oct 2005 → Apr 2009 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Jewish General Hospital | Terminated | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT01868893 Background | Aug 2013 → Jan 2014 | B-cell chronic lymphocytic leukemia | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01109264 Comparator | Mar 2010 → Jun 2013 | B-cell chronic lymphocytic leukemia | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00875667 Comparator | Apr 2009 → Jun 2018 | mantle cell lymphoma | Celgene Corporation | Completed | No outcome recorded |
| Phase 316 trials | ||||||
| Phase 3 | NCT06319456 Comparator | Apr 2024 → Aug 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT04578613 Comparator | Jan 2021 → Dec 2024 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Beijing InnoCare Pharma Tech Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04075292 Comparator | Jan 2020 → Jan 2024 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03462719 Comparator | Apr 2018 → Feb 2021 overdue | B-cell chronic lymphocytic leukemia | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02612311 Comparator | Nov 2015 → Feb 2023 | B-cell chronic lymphocytic leukemia | TG Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02475681 Comparator | Jun 2015 → Feb 2019 overdue | B-cell chronic lymphocytic leukemia | Acerta Pharma BV | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01980875 Comparator | Apr 2015 → May 2016 | B-cell chronic lymphocytic leukemia | Gilead Sciences | Terminated | No outcome recorded |
| Phase 3 | NCT01722487 Comparator | Mar 2013 → May 2015 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Pharmacyclics LLC. | Completed | No outcome recorded |
| Phase 3 | NCT01678430 Comparator | Dec 2011 → Dec 2017 | B-cell chronic lymphocytic leukemia | University of Liverpool | Unknown | No outcome recorded |
| Phase 3 | NCT01657955 Comparator | Jan 2011 → Oct 2013 | B-cell chronic lymphocytic leukemia | Shandong Lanjin Pharmaceuticals Co.,Ltd | Unknown | No outcome recorded |
| Phase 3 | NCT00910910 Comparator | Oct 2009 → Mar 2014 | B-cell chronic lymphocytic leukemia | Celgene Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00748189 Background | Dec 2008 → Mar 2013 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00117598 Comparator | May 2005 → Aug 2007 | lymphoma | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00262795 Comparator | Sep 2003 → Jan 2005 | chronic lymphocytic leukemia/small lymphocytic lymphoma | German CLL Study Group | Completed | No outcome recorded |
| Phase 3 | NCT00210353 Comparator | Jan 2003 → Apr 2015 | MALT lymphoma | International Extranodal Lymphoma Study Group (IELSG) | Completed | No outcome recorded |
| Phase 3 | NCT00566332 Comparator | Jun 2001 → Sep 2009 | Waldenstrom macroglobulinemia, splenic marginal zone lymphoma | French Study Group on Chronic Lymphoid Leukemia | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT01283386 Comparator | Apr 2011 → Mar 2016 | B-cell chronic lymphocytic leukemia | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 4 | NCT00132691 Comparator | Sep 2005 → Dec 2010 | uveitis | JHSPH Center for Clinical Trials | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-06-12 | AbbVie | IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Shows Superior Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in First-line Chronic Lymphocytic Leukemia (CLL) Phase 3 GLOW Study abbvie.com ↗ |
| 2018-12-03 | AbbVie | IMBRUVICA® (ibrutinib) Phase 3 Combination Data with Obinutuzumab Finds Significant Improvement in Progression-Free Survival (PFS) Over Standard Chemoimmunotherapy of Chlorambucil Plus Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) abbvie.com ↗ |
| 2017-06-05 | AbbVie | New Data Presented at ASCO 2017 Finds IMBRUVICA® (ibrutinib) May Offer a More Targeted Approach to Chronic Lymphocytic Leukemia (CLL) Treatment than Chemotherapy Agent Chlorambucil in Treatment-Naïve Patients abbvie.com ↗ |
| 2015-04-15 | Novartis Pharmaceuticals | Data in The Lancet show Novartis drug Arzerra® plus chlorambucil improved median progression-free survival by 71% in CLL patients novartis.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Chlorambucil | “Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days” NCT00117598 ↗53“Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, or Fludarabine” NCT00875667 ↗ “Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.” NCT04578613 ↗ “azathioprine chlorambucil (Leukeran)” NCT00132691 ↗ “Carmustine, Chlorambucil, Cisplatin” NCT02788201 ↗ |
| Known as | Ambochlorin | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | CB-1348 | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | Chlorambucil: Leukeran | “Chlorambucil: Leukeran” NCT02100852 ↗ |
| Known as | Chlorambucilum | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | Clorambucilo | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | Ecloril | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | Leukeran | “azathioprine chlorambucil (Leukeran)” NCT00132691 ↗ |
| Known as | Lympholysin | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | NCI-3088 | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Known as | NSC-3088 | ChEMBL registry synonym — accepted as the source's own label CHEMBL515 ↗ |
| Modality | Other / unclassified | “An alkylating agent (cyclophosphamide or chlorambucil) combined with a corticosteroid regimen” PMID 34778952 ↗ Nov 2021 |
| Route | Oral | “Patients receive oral chlorambucil, procarbazine, and prednisolone on days 1-14;” NCT00003421 ↗ |