Drugs / Bleomycin
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Bleomycin

Developed for
lymphoma · Hodgkins lymphoma · extragonadal germ cell tumor · Kaposi's sarcoma · testicular germ cell tumor · classic Hodgkin lymphoma · head and neck cancer · childhood germ cell tumor
+59 more · teratoma · hemangioma · central nervous system neoplasm · cervical cancer · diffuse large B-cell lymphoma · Hodgkin's lymphoma, lymphocytic depletion · Hodgkin's lymphoma, mixed cellularity · metastatic malignant neoplasm · nodular lymphocyte predominant Hodgkin lymphoma · nodular sclerosis classical Hodgkin lymphoma · non-Hodgkin lymphoma · ovarian cancer · peripheral T-cell lymphoma, not otherwise specified · testicular seminoma · vulva cancer · breast cancer · cancer · central nervous system germinoma · childhood testicular germ cell tumor · common wart · cutaneous melanoma · extragonadal nonseminomatous germ cell tumor · female reproductive organ cancer · gastric cancer · germ cell tumor · head and neck squamous cell carcinoma · keloid · large B-cell lymphoma · liver cancer · lymphatic malformation · malignant mixed neoplasm · malignant pancreatic neoplasm · mediastinal cancer · metastasis from malignant tumor of colon · metastatic carcinoma · metastatic malignant neoplasm in the brain · nongerminomatous germ cell tumor · ovarian carcinoma · ovarian embryonal carcinoma · ovarian granulosa cell tumor · ovarian gynandroblastoma · ovarian Sertoli-Leydig cell tumor · ovarian yolk sac tumor · pediatric ovarian germ cell tumor · pericardial effusion · plantar wart · plasma cell neoplasm · skin cancer · skin neoplasm · testicular embryonal carcinoma · testicular non-seminomatous germ cell tumor · urinary bladder cancer · urothelial carcinoma · vascular malformation · vulval Paget disease · capillary malformation · malignant germ cell tumor of ovary · neoplasm of testis · ovarian sex cord-stromal tumor
Investigated by
National Cancer Institute (NCI) · European Organisation for Research and Treatment of Cancer - EORTC · Children's Oncology Group · National Institute of Allergy and Infectious Diseases (NIAID) · Eastern Cooperative Oncology Group · Fondazione Italiana Linfomi - ETS
+122 more · Institute of Oncology Ljubljana · Lymphoma Study Association · SWOG Cancer Research Network · Children's Cancer and Leukaemia Group · Inovio Pharmaceuticals · Lymphoma Trials Office · M.D. Anderson Cancer Center · Medical Research Council · Stanford University · University of Cologne · Cancer Research UK · Copenhagen University Hospital at Herlev · Rigshospitalet, Denmark · Sequus Pharmaceuticals · Alliance for Clinical Trials in Oncology · Amgen · Cambridge University Hospitals NHS Foundation Trust · Cancer and Leukemia Group B · Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte · Children's Cancer Group · French Innovative Leukemia Organisation · Herlev Hospital · King Edward Medical University · Memorial Sloan Kettering Cancer Center · Ministry of Health, Labour and Welfare, Japan · PCI Biotech AS · Seagen Inc. · St. Jude Children's Research Hospital · UNICANCER · University Medical Centre Ljubljana · University of Ljubljana · Uppsala University Hospital · Zealand University Hospital · AIDS Malignancy Consortium · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Australasian Leukaemia and Lymphoma Group · Australian and New Zealand Urogenital and Prostate Cancer Trials Group · Barbara Ensoli, MD, PhD · Baylor College of Medicine · Bristol-Myers Squibb · Cancer Institute WIA · Cancer Research UK & UCL Cancer Trials Centre · Cancer Trials Ireland · Case Comprehensive Cancer Center · Centre Leon Berard · Centro di Riferimento Oncologico - Aviano · City of Hope Medical Center · Clinica Dermatologica Arbache ltda · Consorzio Mario Negri Sud · Dana-Farber Cancer Institute · Deutsche AIDS Gesellschaft e.V. · ECOG-ACRIN Cancer Research Group · Fondation ARC · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · GITIL (GRUPPO ITALIANO TERAPIE INNOVATIVE NEI LINFOMI) · GOG Foundation · Genentech, Inc. · Glostrup University Hospital, Copenhagen · Grup per l'Estudi dels Limfomes de Catalunya i Balears · Gustave Roussy, Cancer Campus, Grand Paris · H. Lee Moffitt Cancer Center and Research Institute · Harlachinger Krebshilfe e.V. · Haruhiko Fukuda · Haukeland University Hospital · Heinrich-Heine University, Duesseldorf · Helwan University · Hospital JP Garrahan · IRCCS Azienda Ospedaliero-Universitaria di Bologna · Ichor Medical Systems Incorporated · Institute of Cancer Research, United Kingdom · Janssen-Cilag International NV · Japan Clinical Oncology Group · Jinnah Postgraduate Medical Centre · Julie Gehl · all 128 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) BLENOXANE — 1996-02-20 fda.gov ↗
Approved US (FDA) BLENOXANE — 1973-07-31 fda.gov ↗

Trials 137 · started per year

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials
Phase 1 NCT04139070 Jun 2020 → Jan 2021 gastric cancer Zealand University Hospital Unknown No outcome recorded
Phase 1 NCT01872923 Jan → Oct 2012 skin cancer PCI Biotech AS Completed No outcome recorded
Phase 1 NCT01322100 Apr 2011 → Jul 2013 metastatic malignant neoplasm in the brain Copenhagen University Hospital at Herlev Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT00031902 Oct 2001 → ? lymphoma Lymphoma Trials Office Unknown No outcome recorded
Phase 1 NCT00027521 Dec 2000 → ? malignant pancreatic neoplasm Ichor Medical Systems Incorporated Withdrawn No outcome recorded
Phase 1 NCT00006035 Jun 2000 → ? cutaneous melanoma H. Lee Moffitt Cancer Center and Research Institute Unknown No outcome recorded
Phase 1 NCT00000987 ? → Apr 1992 HIV infectious disease, Kaposi's sarcoma National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00000954 ? → Sep 1996 HIV infectious disease, Kaposi's sarcoma National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT02291133 Jun 2014 → Sep 2019 liver cancer Masa Bosnjak Completed No outcome recorded
Phase 1/2 NCT00032149 Oct 2001 → ? lymphoma Lymphoma Trials Office Unknown No outcome recorded
Phase 254 trials · 2 met primary · 2 missed
Phase 2 NCT07579962 Sep 2026 → Jun 2031 expected vascular malformation Institute of Oncology Ljubljana Recruiting No outcome recorded
Phase 2 NCT06144736 Aug 2023 → Aug 2026 overdue testicular seminoma Heinrich-Heine University, Duesseldorf Recruiting No outcome recorded
Phase 2 NCT06715592 May 2023 → Mar 2025 overdue vulval Paget disease Fondazione Policlinico Universitario Agostino Gemelli IRCCS Active not recruiting No outcome recorded
Phase 2 NCT06437158 Mar 2023 → Dec 2025 overdue lymphatic malformation West China Hospital Recruiting No outcome recorded
Phase 2 NCT05395962 Apr 2022 → Apr 2025 overdue vulva cancer IRCCS Azienda Ospedaliero-Universitaria di Bologna Recruiting No outcome recorded
Phase 2 NCT05008224 Oct 2021 → Oct 2023 classic Hodgkin lymphoma Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 2 NCT05023408 Jan → Jun 2021 common wart Jinnah Postgraduate Medical Centre Completed No outcome recorded
Phase 2 NCT04760327 Jul 2020 → Dec 2025 overdue female reproductive organ cancer Institute of Oncology Ljubljana Recruiting No outcome recorded
Phase 2 NCT03755804 Dec 2018 → Jan 2027 expected classic Hodgkin lymphoma St. Jude Children's Research Hospital Active not recruiting No outcome recorded
Phase 2 NCT03712202 Nov 2018 → Dec 2024 overdue Hodgkin's lymphoma, lymphocytic depletion, Hodgkin's lymphoma, mixed cellularity, nodular sclerosis classical Hodgkin lymphoma City of Hope Medical Center Active not recruiting No outcome recorded
Phase 2/31 trial · 1 missed
Phase 2/3 NCT00784537 Sep 2008 → Jan 2015 Hodgkins lymphoma Fondazione Italiana Linfomi - ETS Completed Missed primary
Phase 350 trials · 2 met primary · 8 missed
Phase 3 NCT05675410 May 2023 → Apr 2031 expected Hodgkins lymphoma National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 3 NCT04638790 Feb 2020 → Dec 2026 expected classic Hodgkin lymphoma State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia Recruiting No outcome recorded
Phase 3 NCT03159897 Aug 2017 → Nov 2021 classic Hodgkin lymphoma Fondazione Italiana Linfomi - ETS Completed No outcome recorded
Phase 3 NCT03018626 Jul 2017 → Jan 2020 diffuse large B-cell lymphoma Nanfang Hospital, Southern Medical University Unknown No outcome recorded
Phase 3 NCT02341989 Apr 2015 → May 2027 expected testicular seminoma St. Olavs Hospital Active not recruiting No outcome recorded
Phase 3 NCT02582697 Feb 2014 → Dec 2029 expected germ cell tumor University of Sydney Recruiting No outcome recorded
Phase 3 NCT01435018 Oct 2013 → Mar 2018 HIV infectious disease Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections Completed Missed primary
Phase 3 NCT01652261 May 2013 → Oct 2014 Hodgkins lymphoma European Organisation for Research and Treatment of Cancer - EORTC Withdrawn No outcome recorded Stop: Enrollment
Phase 3 NCT01726374 Feb 2010 → Aug 2016 testicular non-seminomatous germ cell tumor Institute of Cancer Research, United Kingdom Completed Met primary
Phase 3 NCT01026220 Dec 2009 → Mar 2012 nodular lymphocyte predominant Hodgkin lymphoma Children's Oncology Group Completed No outcome recorded
Phase 47 trials
Phase 4 NCT07197541 Oct 2025 → Nov 2026 expected plantar wart Second Affiliated Hospital, School of Medicine, Zhejiang University Active not recruiting No outcome recorded
Phase 4 NCT06647342 Oct 2024 → Mar 2027 expected chemotherapy-induced toxicity, malignant mixed neoplasm, metastatic carcinoma, pulmonary fibrosis Julie Gehl Recruiting No outcome recorded
Phase 4 NCT04046679 Aug 2019 → Aug 2020 — Clinica Dermatologica Arbache ltda Unknown No outcome recorded
Phase 4 NCT03500133 Oct 2017 → Oct 2027 expected Hodgkins lymphoma Hospital JP Garrahan Recruiting No outcome recorded
Phase 4 NCT00198276 Feb 2004 → Sep 2008 cancer Inovio Pharmaceuticals Completed No outcome recorded
Phase 4 NCT00198263 Jan 2004 → Sep 2008 head and neck cancer Inovio Pharmaceuticals Completed No outcome recorded
Phase 4 NCT00188149 May 2000 → Dec 2007 Hodgkins lymphoma University Hospital Carl Gustav Carus Unknown No outcome recorded
Phase not applicable15 trials · 1 missed
— NCT07201766 Dec 2025 → Feb 2026 overdue keloid King Edward Medical University Not yet recruiting No outcome recorded
— NCT07104526 Jan 2024 → Jan 2025 hemangioma Wuhan Integrated Traditional Chinese and Western Medicine Hospital Completed No outcome recorded
— NCT05705687 May 2023 → Feb 2031 expected nongerminomatous germ cell tumor Gustave Roussy, Cancer Campus, Grand Paris Recruiting No outcome recorded
— NCT07171827 Mar 2023 → Feb 2025 classic Hodgkin lymphoma Helwan University Completed No outcome recorded
— NCT06080724 Mar → Dec 2021 hemangioma King Edward Medical University Completed No outcome recorded
— NCT05916690 Mar 2021 → Dec 2024 vulva cancer Institute of Oncology Ljubljana Unknown No outcome recorded
— NCT02800447 Jun 2016 → Dec 2018 Hodgkins lymphoma Lee's Pharmaceutical Limited Unknown No outcome recorded
— NCT05327309 May 2015 → May 2017 hemangioma Shaheed Zulfiqar Ali Bhutto Medical University Completed No outcome recorded
— NCT01578967 Apr 2012 → Aug 2016 Hodgkins lymphoma UNC Lineberger Comprehensive Cancer Center Completed No outcome recorded
— NCT01304849 Jan 2011 → Sep 2013 Hodgkins lymphoma Cancer Institute WIA Completed Missed primary
Comparator or background therapy51 trials
Phase 1 NCT01060904 Background Jan 2010 → Sep 2012 Hodgkins lymphoma Seagen Inc. Completed No outcome recorded
Phase 1 NCT00993512 Background Aug 2009 → May 2011 head and neck neoplasm, skin neoplasm PCI Biotech AS Completed No outcome recorded
Phase 1 NCT00000689 Background ? → Mar 1991 HIV infectious disease, non-Hodgkin lymphoma National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00000681 Background ? → Oct 1993 HIV infectious disease, Kaposi's sarcoma National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/2 NCT03033914 Background Jan 2017 → Jan 2027 expected classic Hodgkin lymphoma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2024-06-01 Pfizer Results Takeda and Pfizer Announce Four-Year Results from Positive Phase 3 HD21 Trial of Additional ADCETRIS® (brentuximab vedotin) Combination in Frontline Hodgkin Lymphoma pfizer.com ↗
The four-year analysis presented by the GHSG showed superior progression-free survival (PFS) and improved tolerability for patients compared to a current standard of care regimen used in Europe in this setting.
2022-05-26 Takeda Results Takeda and Seagen to Highlight ADCETRIS ® Combination Data Showing Statistically Significant Improvement in Overall Survival (OS) for Patients with Advanced Hodgkin Lymphoma takeda.com ↗
These results clearly show that the addition of brentuximab vedotin to chemotherapy improves the long-term outcome of patients and the combination should be considered a standard of care.

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 188 sources stand behind the page.

FieldValueCited text
Known as Bleomycin “Chemotherapy is based upon regimes with well known effectiveness in Hodgkin lymphoma. (i.e. ABVD: doxorubicin, bleomycin, vinblastine and dacarbazine and ESHAP: Etoposide,...” NCT03500133 ↗
166

“The other half (Group II) will receive a combination of intravenous Adriamycin, Bleomycin, Vinblastine and Dacarbazine every other week for 12 treatments.” NCT00797472 ↗

“Doxorubicin 25 mg/m2 IV, Bleomycin 10,000 units/m2 IV, Vinblastine 6 mg/m2 IV, Dacarbazine 375 mg/m2 IV on days 1-15 of each 28 day cycle.” NCT02275598 ↗

“BACOPP-D regimen which includes cyclophosphamide, adriamycin, dacarbazine, procarbazine, prednisolone, bleomycin and vincristine” NCT00188149 ↗

“Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle” NCT00901303 ↗

“doxorubicin 25 mg/m\^2 IV bleomycin 10 units/m\^2 IV vinblastine 6 mg/m\^2 IV dacarbazine 375 mg/m\^2 IV” NCT01118026 ↗

“BEACOPPescalated consisted of bleomycin 10 mg/m2 and vincristine 1·4 mg/m2 intravenously on day 8” PMID 30658935 ↗ Jan 2019

“doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD)-based response-adapted therapy” NCT01652261 ↗

“Bleomycin (B) 5units/m2/day IV over 10min on Day 1 10units/m2/day IV over 10min on Day 8” NCT01858922 ↗

“Adriamycin 25mg/m2, Bleomycin10,000units/m2, Vinblastine 6mg/m2 and Dacarbazine 375mg/m2” NCT03527628 ↗

“vincristine sulfate IV and bleomycin IV on day 1 of weeks 2, 4, 6, and 8” NCT00846742 ↗

Show 156 more sources

Known as BLEO “Bleomycin, BLEO, NSC-125066” NCT00002462 ↗
1

“BLEO Bleomycin, NSC-125066” NCT00002565 ↗

Known as Bleomicina ClinicalTrials.gov intervention name — accepted as the source's own label NCT06715592 ↗
1

NCT01067690 ↗

Known as Bleomicine “Esc.BEACOPP Bleomicine10 mg/m2/ev/die 8°” NCT00795613 ↗
Known as Bleomycin (B) “Bleomycin (B)” NCT01858922 ↗
Known as Bleomycin hydrochloride “Bleomycin hydrochloride injection: 10mg/m2, IV or IM, day 8” NCT02800447 ↗
Known as Bleomycin PHC 15 e. “Bleomycin PHC 15 e. (United States Pharmacopeia - USP)” NCT02352259 ↗
Known as Bleomycin Sulfate “The MedPulser device will be used in combination with Bleomycin Sulfate injection around the tumor area in a concentration of 1 U/ml per cm3 of tumor treatment area.” NCT00198276 ↗
29

“Patients receive injections of Bleomycin Sulfate at a concentration of 1 U/ml per cm3 of tumor treatment area followed by electroporation.” NCT00198328 ↗

“Bleomycin sulfate was administered at a dose of 15 units/m\^2 over 10 minutes every 3 weeks.” NCT01435018 ↗

“Bleomycin (active name: Bleomycin Sulfate)” NCT02582697 ↗

“Biological: bleomycin sulfate” NCT00002571 ↗

“Biological: bleomycin sulfate” NCT00678327 ↗

“Biological: bleomycin sulfate” NCT00079105 ↗

“Biological: bleomycin sulfate” NCT00005090 ↗

“Biological: bleomycin sulfate” NCT00002565 ↗

“Biological: Bleomycin sulfate” NCT00002715 ↗

“Biological: bleomycin sulfate” NCT00049595 ↗

Show 19 more sources

Known as NSC-125066 “Bleomycin, BLEO, NSC-125066” NCT00002462 ↗
2

“Bleomycin, BLEO, NSC-125066” NCT00002476 ↗

“BLEO Bleomycin, NSC-125066” NCT00002565 ↗

Action Inhibit “Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells” NCT00654732 ↗
Route Intravenous “Four medicines are given on day 1 of each cycle by vein (IV) (doxorubicin, cyclophosphamide, bleomycin, vincristine).” NCT00000689 ↗