Drugs / Thiotepa
last change 10 days ago re-read 8 days ago

Thiotepa

Other / unclassified

Developed for
myelodysplastic syndrome · breast cancer · neuroblastoma · acute myeloid leukemia · lymphoma · leukemia · primary central nervous system lymphoma · central nervous system neoplasm
+128 more · acute lymphoblastic leukemia · chronic myeloid leukemia · plasma cell myeloma · chronic lymphocytic leukemia/small lymphocytic lymphoma · Hodgkins lymphoma · medulloblastoma · ovarian cancer · central nervous system non-hodgkin lymphoma · childhood germ cell tumor · retinoblastoma · sarcoma · atypical teratoid rhabdoid tumor · brain cancer · childhood malignant neoplasm · non-Hodgkin lymphoma · testicular germ cell tumor · brain neoplasm · cancer of unknown primary site · central nervous system cancer · diffuse large B-cell lymphoma · extragonadal germ cell tumor · immunodeficiency disease · lymphoblastic lymphoma · myelofibrosis · neoplastic meningitis · acute biphenotypic leukemia · bone marrow failure syndrome · Burkitt lymphoma · CD4+/CD56+ hematodermic neoplasm · chronic granulomatous disease · chronic myelomonocytic leukemia · common variable immunodeficiency · female breast carcinoma · hemophagocytic syndrome · Hurler syndrome · mantle cell lymphoma · paroxysmal nocturnal hemoglobinuria · pineoblastoma · primitive neuroectodermal tumor · severe combined immunodeficiency · sickle cell disease · supratentorial primitive neuroectodermal tumor · thalassemia · Wiskott-Aldrich syndrome · X-linked lymphoproliferative syndrome · acquired thrombocytopenia · acute leukemia · adrenoleukodystrophy · aggressive B-cell non-Hodgkin lymphoma · anaplastic ependymoma · anemia · atypical chronic myeloid leukemia, BCR-ABL1 negative · autoimmune lymphoproliferative syndrome · B-cell acute lymphoblastic leukemia · B-cell non-Hodgkin lymphoma · benign neoplasm · beta thalassemia · brain glioblastoma · breast carcinoma · Bruton-type agammaglobulinemia · central nervous system germ cell tumor · central nervous system leukemia · cerebral primitive neuroectodermal tumor · Chediak-Higashi syndrome · childhood medulloblastoma · choriocarcinoma · choroid plexus carcinoma · Diamond-Blackfan anemia · DiGeorge syndrome · embryonal carcinoma · embryonal tumor with multilayered rosettes · ependymoblastoma · Ewing sarcoma · Ewing sarcoma/peripheral primitive neuroectodermal tumor · extraocular retinoblastoma · follicular lymphoma · head and neck cancer · hematologic disorder · hemolytic anemia · hepatoblastoma · histiocytosis · hyper-IgM syndrome · IDH-wildtype glioblastoma · immune dysregulation, autoimmunity, and autoinflammation · immune dysregulation-polyendocrinopathy-enteropathy-X-linked syndrome · inborn errors of metabolism · inflammatory breast carcinoma · invasive breast carcinoma · juvenile myelomonocytic leukemia · kidney cancer · kidney neoplasm · liver cancer · lymphoid hemopathy · lymphoplasmacytic lymphoma · lymphoproliferative syndrome · malignant leptomeningeal tumor · marginal zone lymphoma · mature T-cell and NK-cell non-Hodgkin lymphoma · medulloblastoma non-WNT/non-SHH group 3 · medulloblastoma non-WNT/non-SHH group 4 · medulloblastoma SHH activated and TP53 wild-type · medulloepithelioma · metastatic neoplasm · mixed germ cell tumor · mixed phenotype acute leukemia · myelodysplastic/myeloproliferative disease · myelodysplastic/myeloproliferative neoplasm · myeloid leukemia · myeloid sarcoma · myeloproliferative neoplasm · neutropenia · oligosaccharidosis · osteosarcoma · ovarian carcinoma · Philadelphia-positive myelogenous leukemia · pineal region immature teratoma · pineal region yolk sac tumor · primary brain neoplasm · prolymphocytic leukemia · rhabdomyosarcoma · soft tissue sarcoma · systemic sclerosis · T lymphoblastic leukemia/lymphoma · T-cell non-Hodgkin lymphoma · teratoma · urinary bladder cancer · urothelial carcinoma · hematopoietic and lymphoid cell neoplasm
Investigated by
National Cancer Institute (NCI) · Fred Hutchinson Cancer Center · Memorial Sloan Kettering Cancer Center · Children's Oncology Group · M.D. Anderson Cancer Center · Washington University School of Medicine
+121 more · Gustave Roussy, Cancer Campus, Grand Paris · Masonic Cancer Center, University of Minnesota · Second Affiliated Hospital, School of Medicine, Zhejiang University · Herbert Irving Comprehensive Cancer Center · NYU Langone Health · Roswell Park Cancer Institute · Samsung Medical Center · The First Affiliated Hospital with Nanjing Medical University · The Netherlands Cancer Institute · University Hospital Freiburg · University Hospital Tuebingen · Zhejiang Cancer Hospital · Assistance Publique - Hôpitaux de Paris · Association for Training, Education, and Research in Hematology, Immunology, and Transplantation · Children's Cancer and Leukaemia Group · Children's Hospital Los Angeles · Children's of Alabama · First Affiliated Hospital Xi'an Jiaotong University · German Federal Ministry of Education and Research · Hackensack Meridian Health · Institut Curie · Klinikum Stuttgart · National Heart, Lung, and Blood Institute (NHLBI) · Northwestern University · Peking University People's Hospital · Ruijin Hospital · Scottish Cancer Therapy Network · Seoul National University Hospital · Sheba Medical Center · The Affiliated Brain Hospital of Nanjing Medical University · UNICANCER · ALL SCTped Forum · ALL-BFM Study Group · Adienne SA · Alliance for Clinical Trials in Oncology · Amgen · Andrés José Maria Ferreri · Australian & New Zealand Children's Haematology/Oncology Group · Baptist Health South Florida · Barbara Ann Karmanos Cancer Institute · Beijing Friendship Hospital · C17 Council · Cancer and Leukemia Group B · Carelon Research · Case Comprehensive Cancer Center · Centre Leon Berard · Charite University, Berlin, Germany · Children's Discovery Institute · Children's Hospitals and Clinics of Minnesota · City of Hope Medical Center · Columbia University · Dutch Childhood Oncology Group · Eastern Cooperative Oncology Group · European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma · European Society for Blood and Marrow Transplantation · FengYan Jin · First Affiliated Hospital of Zhejiang University · Fudan University · GWT-TUD GmbH · Georgetown University · German Society of Paediatric Oncology and Hematology (GPOH gGmbH) · Guangdong 999 Brain Hospital · Guenther Koehne · H. Lee Moffitt Cancer Center and Research Institute · Heinrich-Heine University, Duesseldorf · Hoffmann-La Roche · Huiqiang Huang · International Extranodal Lymphoma Study Group (IELSG) · Italian Group for Bone Marrow Transplantation · Jazz Pharmaceuticals · Jun Zhu · King's College Hospital NHS Trust · Live Like Bella Pediatric Cancer Research · Louisiana State University Health Sciences Center Shreveport · all 127 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Tepadina — 2010-03-15 europa.eu ↗
Approved US (FDA) THIOTEPA — 1959-03-09 fda.gov ↗

Trials 164 · started per year

today
US approved 1959
EU approved 2010
1
1
1
3
3
3
9
6
6
4
5
4
1
5
4
5
8
4
10
4
4
2
2
3
6
3
2
7
3
1
8
9
2
7
10
8
195819591960196119621963196419651966196719681969197019711972197319741975197619771978197919801981198219831984198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06942039 Sep 2025 → Dec 2030 expected atypical teratoid rhabdoid tumor, childhood medulloblastoma, embryonal tumor with multilayered rosettes, ependymoblastoma +5 C17 Council Recruiting No outcome recorded
Phase 111 trials
Phase 1 NCT06195891 May 2024 → Mar 2030 expected acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome City of Hope Medical Center Recruiting No outcome recorded
Phase 1 NCT05088356 Sep 2021 → May 2028 expected acute leukemia, chronic myeloid leukemia, disease related to hematopoietic stem cell transplant, myelodysplastic syndrome Stanford University Active not recruiting No outcome recorded
Phase 1 NCT04521946 Jan 2021 → Dec 2022 anaplastic ependymoma, atypical teratoid rhabdoid tumor, central nervous system germ cell tumor, choroid plexus carcinoma +3 M.D. Anderson Cancer Center Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT02660281 Oct 2015 → Oct 2019 immunodeficiency disease, myelofibrosis, plasma cell myeloma University of Rochester Completed No outcome recorded
Phase 1 NCT00972101 Sep 2009 → Sep 2011 disease related to hematopoietic stem cell transplant, leukemia, lymphoma M.D. Anderson Cancer Center Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT00867178 Feb 2009 → Apr 2020 medulloblastoma, pineoblastoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT00003899 Jan 1999 → Nov 2001 cancer of unknown primary site Fred Hutchinson Cancer Center Completed No outcome recorded
Phase 1 NCT00003141 Mar 1998 → Dec 2007 brain cancer, neuroblastoma, sarcoma Children's Oncology Group Completed No outcome recorded
Phase 1 NCT00003081 Mar 1998 → Jan 2002 sarcoma Fred Hutchinson Cancer Center Completed No outcome recorded
Phase 1 NCT00002977 Jan 1997 → Nov 2001 ovarian cancer Fred Hutchinson Cancer Center Completed No outcome recorded
Phase 1/28 trials
Phase 1/2 NCT06158828 Nov 2024 → Sep 2028 expected acute myeloid leukemia by FAB classification, childhood acute myeloid leukemia Washington University School of Medicine Recruiting No outcome recorded
Phase 1/2 NCT05021770 Dec 2021 → Dec 2022 non-Hodgkin lymphoma, primary central nervous system lymphoma Huiqiang Huang Unknown No outcome recorded
Phase 1/2 NCT03513328 Jun 2018 → Feb 2022 Diamond-Blackfan anemia, Hurler syndrome, Wiskott-Aldrich syndrome, X-linked lymphoproliferative syndrome +12 University of Florida Completed No outcome recorded
Phase 1/2 NCT00801931 Sep 2007 → May 2009 anemia, immunodeficiency disease, leukemia, lymphoma +1 Columbia University Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT00112567 Apr 2003 → Jul 2007 leukemia, myelodysplastic syndrome Fred Hutchinson Cancer Center Completed No outcome recorded
Phase 1/2 NCT00920972 Dec 2001 → Dec 2026 expected inherited hemoglobinopathy, metabolic disease Washington University School of Medicine Recruiting No outcome recorded
Phase 1/2 NCT00003297 Dec 1997 → Jan 2001 ovarian cancer Georgetown University Completed No outcome recorded
Phase 1/2 NCT00003086 Mar 1997 → Jan 2001 female breast carcinoma Louisiana State University Health Sciences Center Shreveport Terminated No outcome recorded Stop: Enrollment
Phase 2103 trials · 4 met primary
Phase 2 NCT07812493 Sep 2026 → Sep 2028 expected diffuse large B-cell lymphoma Pengpeng Xu Not yet recruiting No outcome recorded
Phase 2 NCT05565105 Jun 2026 → Jun 2033 expected acute lymphoblastic leukemia, acute myeloid leukemia Guenther Koehne Not yet recruiting No outcome recorded
Phase 2 NCT07604987 May 2026 → May 2028 expected primary central nervous system lymphoma Zou Dehui Recruiting No outcome recorded
Phase 2 NCT07481669 Mar 2026 → Mar 2028 expected lymphoma Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting No outcome recorded
Phase 2 NCT07416890 Feb 2026 → Aug 2028 expected central nervous system non-hodgkin lymphoma Zhejiang Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT07511725 Jan 2026 → Jan 2028 expected IDH-wildtype glioblastoma Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting No outcome recorded
Phase 2 NCT07276737 Dec 2025 → Dec 2029 expected mature T-cell and NK-cell non-Hodgkin lymphoma Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting No outcome recorded
Phase 2 NCT07263425 Oct 2025 → Oct 2027 expected neoplastic meningitis The First Affiliated Hospital with Nanjing Medical University Recruiting No outcome recorded
Phase 2 NCT06869265 May 2025 → Apr 2028 expected acute myeloid leukemia Peking University People's Hospital Recruiting No outcome recorded
Phase 2 NCT07193654 Apr 2025 → Apr 2027 expected brain glioblastoma Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting No outcome recorded
Phase 2/36 trials · 1 missed
Phase 2/3 NCT04217278 Jan 2020 → May 2026 overdue acute myeloid leukemia, myelodysplastic syndrome University of Birmingham Active not recruiting No outcome recorded
Phase 2/3 NCT01949129 Apr 2013 → Jun 2030 expected acute lymphoblastic leukemia St. Anna Children's Cancer Research Recruiting No outcome recorded
Phase 2/3 NCT01057069 Jan 2010 → Jun 2023 overdue breast cancer The Netherlands Cancer Institute Active not recruiting Missed primary
Phase 2/3 NCT00448266 May 2007 → Feb 2010 breast cancer The Netherlands Cancer Institute Terminated No outcome recorded
Phase 2/3 NCT00749723 Feb 2006 → Jan 2015 ependymoma, medulloblastoma, supratentorial primitive neuroectodermal tumor University Hospital, Bonn Completed No outcome recorded
Phase 2/3 NCT00003816 Oct 1998 → Jul 2019 benign neoplasm, childhood malignant neoplasm, leukemia, lymphoma +3 Roswell Park Cancer Institute Completed No outcome recorded
Phase 318 trials · 1 met primary · 3 missed
Phase 3 NCT07291102 Jul 2026 → Oct 2034 expected medulloblastoma SHH activated and TP53 wild-type Nationwide Children's Hospital Not yet recruiting No outcome recorded
Phase 3 NCT06830421 Aug 2023 → Aug 2029 expected primary central nervous system lymphoma University Hospital Freiburg Recruiting No outcome recorded
Phase 3 NCT04931368 Jun 2021 → Jun 2028 expected primary central nervous system lymphoma Klinikum Stuttgart Active not recruiting No outcome recorded
Phase 3 NCT04221035 Nov 2019 → Nov 2026 expected neuroblastoma Gustave Roussy, Cancer Campus, Grand Paris Recruiting No outcome recorded
Phase 3 NCT01646034 Sep 2014 → Jan 2023 overdue breast cancer The Netherlands Cancer Institute Active not recruiting Missed primary
Phase 3 NCT01091168 Jul 2009 → Aug 2012 breast cancer, metastatic neoplasm Pierre Fabre Laboratories Completed Missed primary
Phase 3 NCT00653068 Feb 2009 → Sep 2016 atypical teratoid rhabdoid tumor Children's Oncology Group Completed No outcome recorded
Phase 3 NCT00554788 May 2008 → Jun 2018 extraocular retinoblastoma Children's Oncology Group Completed Met primary
Phase 3 NCT00567567 Nov 2007 → Feb 2015 neuroblastoma Children's Oncology Group Completed Mixed
Phase 3 NCT00078988 Oct 2004 → Sep 2006 brain neoplasm Children's Oncology Group Completed No outcome recorded
Phase 42 trials
Phase 4 NCT06230055 Jan 2024 → Jan 2026 overdue Her2-receptor negative breast cancer, malignant leptomeningeal tumor Fudan University Recruiting No outcome recorded
Phase 4 NCT02875314 Sep 2015 → Dec 2030 expected central nervous system cancer, medulloblastoma Parth Patel Active not recruiting No outcome recorded
Phase not applicable15 trials
— NCT07588594 Feb 2026 → May 2028 expected chronic myelomonocytic leukemia Peking University People's Hospital Recruiting No outcome recorded
— NCT07191431 Sep 2025 → Sep 2027 expected central nervous system non-hodgkin lymphoma Ruijin Hospital Recruiting No outcome recorded
— NCT06832267 Feb 2025 → Feb 2027 expected primary central nervous system lymphoma Zhejiang Cancer Hospital Recruiting No outcome recorded
— NCT06385808 May 2024 → Dec 2026 expected acute myeloid leukemia First Affiliated Hospital Xi'an Jiaotong University Not yet recruiting No outcome recorded
— NCT05667402 Jan 2023 → Dec 2025 central nervous system leukemia, disease related to hematopoietic stem cell transplant First Affiliated Hospital Xi'an Jiaotong University Unknown No outcome recorded
— NCT06946407 Dec 2022 → Dec 2027 expected central nervous system non-hodgkin lymphoma FengYan Jin Recruiting No outcome recorded
— NCT05854225 Jan 2022 → Jun 2024 hemophagocytic syndrome Beijing Friendship Hospital Unknown No outcome recorded
— NCT03035422 Jan 2018 → Dec 2021 acute myeloid leukemia Association for Training, Education, and Research in Hematology, Immunology, and Transplantation Completed No outcome recorded
— NCT03079089 Jun 2017 → Sep 2023 lymphoid hemopathy Association for Training, Education, and Research in Hematology, Immunology, and Transplantation Completed No outcome recorded
— NCT01505569 Oct 2011 → Feb 2024 Ewing sarcoma, atypical teratoid rhabdoid tumor, germ cell tumor, hepatoblastoma +6 Masonic Cancer Center, University of Minnesota Completed No outcome recorded
Comparator or background therapy131 trials
Phase 0 NCT02653196 Background Sep 2015 → Aug 2017 neuroepithelial neoplasm Montefiore Medical Center Terminated No outcome recorded
Phase 0 NCT00790413 Background Aug 2005 → Dec 2022 neuroblastoma Lund University Hospital Unknown No outcome recorded
Phase 1 NCT07257419 Background Aug 2026 → Dec 2031 expected childhood acute lymphoblastic leukemia, disease related to hematopoietic stem cell transplant St. Jude Children's Research Hospital Recruiting No outcome recorded
Phase 1 NCT07565220 Background Aug 2026 → Jun 2029 expected acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome Sawa Ito, MD Recruiting No outcome recorded
Phase 1 NCT07052370 Background Sep 2025 → Dec 2028 expected hematopoietic and lymphoid system neoplasm St. Jude Children's Research Hospital Recruiting No outcome recorded
Show all 131 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2019-03-26 Sumitomo Pharma America, Inc. Regulatory Sumitomo Dainippon Pharma Receives Approval in Japan for RETHIO for Conditioning Treatment Prior to Autologous Hematopoietic Stem Cell Transplantation sumitomo-pharma.com ↗
announced today that it received approval in Japan for "RETHIO ® for Intravenous Infusion 100 mg"

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 296 sources stand behind the page.

FieldValueCited text
Known as thiotepa “One or more of the following may be assigned by the physician (physician's choice) per standard of care guidelines upon study enrollment following surgery: Cytarabine,...” NCT06861244 ↗
293

“Study participants will receive a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an...” NCT00145626 ↗

“Four cycles of Induction therapy: Rituximab 375mg/m2 d1; Methotrexate 3.5g/m2 d2;Temozolomide 100mg/m2 d2-6; for patients who reach a CR, PR, or SD, will proceed to autologous...” NCT02399189 ↗

“Twenty-two children with a median age of 2.8 years, many with severe comorbidities and prior viral infections, were enrolled in a novel RIC protocol consisting of hydroxyurea,...” PMID 24296492 ↗ Dec 2013

“Haploidentical stem cell transplant recipients will receive a reduced intensity conditioning regimen consisting of OKT-3, Fludarabine, Thiotepa , and Melphalan followed by an...” NCT00145587 ↗

“Transplant recipients received a reduced intensity conditioning regimen consisting of OKT-3, fludarabine, thiotepa, and melphalan followed by an infusion of a T-cell depleted...” NCT00143559 ↗

“Conditioning: High dose TBI (1320 cGy TBI + Fludarabine 75 mg/m2 + Cyclophosphamide 120 mg/kg) or Intermediate Intensity regimen (400 cGy TBI + Fludarabine 150 mg/m2 +...” NCT04103879 ↗

“Approximately 10 days prior to the transplant procedure, all participants received the same preparative regimen consisting of Busulfan, cyclophosphamide, low-dose thiotepa, and OKT3.” NCT00152113 ↗

“MATRix Regimen: Rituximab 375 mg/m² IV on Day 0; Methotrexate 3.5 g/m² IV on Day 1; Cytarabine 2 g/m² IV twice daily on Days 2-3; Thiotepa 30 mg/m² orally on Day 4.” NCT07350850 ↗

“Transplant recipients received a myeloablative conditioning regimen consisting of total body irradiation, thiotepa, cyclophosphamide, ATG, and OKT3.” NCT00186823 ↗

“Induction therapy: Pirtobrutinib 200 mg once daily, combined with MTX (thiotepa for patients intolerant to MTX) plus chemoimmunotherapy regimens.” NCT07812493 ↗

Show 283 more sources

Known as 1,1',1''-Phosphinothioylidynetrisaziridine “1,1',1''-Phosphinothioylidynetrisaziridine” NCT02220985 ↗
Known as Girostan “Girostan” NCT02220985 ↗
Known as NSC-6396 “Thiotepa, TSPA, NSC-6396” NCT00002471 ↗
1

“TSPA Thiotepa, NSC-6396” NCT00002704 ↗

Known as Tepadina ChEMBL registry synonym — accepted as the source's own label CHEMBL671 ↗
Known as Tepylute ChEMBL registry synonym — accepted as the source's own label CHEMBL671 ↗
Known as Tespamin “Tespamin” NCT02220985 ↗
Known as Thio “Thiotepa (Thio) is one part of the conditioning regimen.10 mg/kg (5 mg/kg per day on days -5 and -4)” NCT06680661 ↗
1

“Thiotepa (THIO) 5 mg/kg x2 (days -5 \& -4)” NCT05884333 ↗

Known as Thioplex ClinicalTrials.gov intervention name — accepted as the source's own label NCT00566696 ↗
Known as Thiotepa riemser ChEMBL registry synonym — accepted as the source's own label CHEMBL671 ↗
Known as Tiotepa ChEMBL registry synonym — accepted as the source's own label CHEMBL671 ↗
Known as triethylenethiophosphoramide “Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent” NCT02626715 ↗
Known as TSPA “myeloablative chemotherapy with thiotepa (TSPA) followed by carboplatin (CBDCA)” NCT00002619 ↗
2

“Thiotepa, TSPA, NSC-6396” NCT00002471 ↗

“TSPA Thiotepa, NSC-6396” NCT00002704 ↗

Action Inhibit “Carboplatin and thiotepa are designed to interfere with the growth of cancer cells by stopping cell division” NCT00429182 ↗
Modality Other / unclassified “Thiotepa, a highly myeloablative bifunctional alkylating agent” NCT00607984 ↗
Route Intravenous “thiotepa IV over 3 hours” NCT00002515 ↗