Thiotepa

Generic Name: Thiotepa

Brand Names: Tepadina, Thiotepa Riemser

Drug Type: Small Molecule

Chemical Formula: C_₆H_₁₂N_₃PS

CAS Number: 52-24-4

Unique Ingredient Identifier: 905Z5W3GKH

Background: N,N'N'-triethylenethiophosphoramide (ThioTEPA) is a cancer chemotherapeutic member of the alkylating agent group, now in use for over 50 years. It is a stable derivative of N,N',N''- triethylenephosphoramide (TEPA). It is mostly used to treat breast cancer, ovarian cancer and bladder cancer. It is also used as conditioning for Bone marrow transplantation. Its main toxicity is myelosuppression.

Indication: ThioTEPA is used a as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients. Also, when high dose chemotherapy with HPCT support it is appropriate for the treatment of solid tumours in adult and paediatric patients.

Associated Conditions: Adenocarcinoma of the Ovaries, Breast Adenocarcinoma, Papillary transitional cell carcinoma of bladder, Malignant effusion

Clinical Trials

CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML

Phase 2

Completed

Conditions: Acute Myeloid Leukemia
Acute Leukemia
Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndromes

Interventions: Drug: CD8+ Memory T Cell Infusion
Drug: Thiotepa
Drug: Fludarabine
Radiation: Hyperfractionated TBI
Drug: Busulfan
Drug: Cyclophosphamide

First Posted Date: 2019-11-05

Last Posted Date: 2024-10-17

Lead Sponsor: Robert Lowsky

Target Recruit Count: 7

Registration Number: NCT04151706

Locations: 🇺🇸
Stanford Medical Center, Stanford, California, United States

Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers

Phase 2

Terminated

Conditions: Acute Megakaryoblastic Leukemia
Acute Myeloid Leukemia
Hematopoietic and Lymphoid Cell Neoplasm
HIV Infection
Acute Erythroid Leukemia
Myelodysplastic Syndrome With Excess Blasts
Non-Hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Myelodysplastic Syndrome

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Radiation: Total-Body Irradiation
Drug: Thiotepa
Procedure: Umbilical Cord Blood Transplantation
Biological: Dilanubicel

First Posted Date: 2019-09-10

Last Posted Date: 2025-01-01

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 1

Registration Number: NCT04083170

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
Cleveland Cord Blood Center, Cleveland, Ohio, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States

and more 2 locations

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Thiotepa in Treating Patients With Non-malignant Disorders

Phase 2

Recruiting

Conditions: Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder

Interventions: Drug: Thiotepa
Drug: Treosulfan
Drug: Fludarabine Phosphate
Biological: Rabbit Anti-Thymocyte Globulin
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Bone Marrow Biopsy
Procedure: Bone Marrow Aspiration
Procedure: Magnetic Resonance Imaging
Procedure: Biospecimen Collection

First Posted Date: 2019-06-10

Last Posted Date: 2025-03-30

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 40

Registration Number: NCT03980769

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)

Phase 2

Recruiting

Conditions: Acute Leukemia
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm

Interventions: Radiation: Total-Body Irradiation
Drug: Thiotepa
Drug: Fludarabine
Drug: Cyclophosphamide
Biological: Peripheral Blood Stem Cell
Drug: Tacrolimus
Biological: Allogeneic CD34+-enriched and CD45RA-depleted PBSCs
Drug: Methotrexate
Drug: Cyclosporine
Drug: Busulfan
Drug: Sirolimus
Procedure: Bone Marrow Aspiration and Biopsy
Procedure: Echocardiography
Procedure: Multigated Acquisition Scan
Procedure: Biospecimen Collection

First Posted Date: 2019-05-31

Last Posted Date: 2025-02-25

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 120

Registration Number: NCT03970096

Locations: 🇺🇸
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

VPA Expanded UCB Transplantation for Treatment of Patients With Hematological Malignancies

Phase 1

Completed

Conditions: Hematological Malignancy
Acute Leukemia in Remission
Acute Lymphoblastic Leukemia in Remission
Myelodysplastic Syndromes
Hodgkin Lymphoma
Non-Hodgkin Lymphoma

Interventions: Biological: Cord blood stem cells
Drug: Valproic Acid
Drug: Fludarabine
Drug: cytoxan
Drug: Thiotepa
Biological: TBI

First Posted Date: 2019-03-22

Last Posted Date: 2021-05-24

Lead Sponsor: Alla Keyzner

Target Recruit Count: 7

Registration Number: NCT03885947

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies

Phase 2

Active, not recruiting

Conditions: Hodgkin Lymphoma
Acute Lymphoblastic Leukemia (ALL)
Acute Myeloid Leukemia (AML)
Myelodysplastic Syndromes (MDS)
NK-Cell Leukemia
Non Hodgkin Lymphoma (NHL)
Juvenile Myelomonocytic Leukemia (JMML)
Chronic Myeloid Leukemia (CML)

Interventions: Drug: Cyclophosphamide
Biological: Fludarabine
Drug: Thiotepa
Drug: Melphalan
Biological: G-csf
Drug: Mesna
Device: CliniMACS
Biological: ATG (rabbit)
Drug: Blinatumomab
Biological: TCRα/β+
Biological: CD19+
Biological: CD45RA-depleted DLI

First Posted Date: 2019-02-21

Last Posted Date: 2025-02-25

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 140

Registration Number: NCT03849651

Locations: 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

Phase 2

Active, not recruiting

Conditions: Ganglioneuroblastoma
High Risk Neuroblastoma

Interventions: Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Dexrazoxane
Biological: Dinutuximab
Drug: Doxorubicin
Drug: Etoposide
Radiation: External Beam Radiation Therapy
Drug: Isotretinoin
Drug: Melphalan
Biological: Sargramostim
Drug: Thiotepa
Drug: Topotecan
Drug: Vincristine

First Posted Date: 2018-12-26

Last Posted Date: 2025-03-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 42

Registration Number: NCT03786783

Locations: 🇺🇸
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
🇳🇿
Starship Children's Hospital, Grafton, Auckland, New Zealand
🇦🇺
The Children's Hospital at Westmead, Westmead, New South Wales, Australia

and more 7 locations

Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant

Phase 2

Recruiting

Conditions: Acute Biphenotypic Leukemia
Acute Leukemia
Acute Leukemia of Ambiguous Lineage
Acute Lymphoblastic Leukemia
Acute Undifferentiated Leukemia
Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Blastic Plasmacytoid Dendritic Cell Neoplasm
Blasts Under 25 Percent of Bone Marrow Nucleated Cells
Blasts Under 5 Percent of Bone Marrow Nucleated Cells
Mixed Phenotype Acute Leukemia

Interventions: Radiation: Total-Body Irradiation
Drug: Thiotepa
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Busulfan
Drug: Tacrolimus
Procedure: Allogeneic Bone Marrow Transplantation
Drug: Methotrexate
Procedure: Naive T Cell-Depleted Hematopoietic Stem Cell Transplantation
Procedure: Echocardiography
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy

First Posted Date: 2018-12-19

Last Posted Date: 2025-04-23

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 68

Registration Number: NCT03779854

Locations: 🇺🇸
Children's Hospital of Los Angeles, Los Angeles, California, United States
🇺🇸
Children's National Medical Center, Washington, District of Columbia, United States
🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States

and more 7 locations

T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other Anemias

Phase 1

Recruiting

Conditions: Diamond-blackfan Anemia
Sickle Cell Anemia
Beta-thalassemia Major

Interventions: Biological: CD3/CD19 depleted leukocytes
Biological: CD45RA depleted leukocytes
Drug: Hydroxyurea
Drug: Rituximab
Drug: Alemtuzumab
Drug: Fludarabine
Drug: Thiotepa

First Posted Date: 2018-08-31

Last Posted Date: 2024-08-09

Lead Sponsor: Paul Szabolcs

Target Recruit Count: 5

Registration Number: NCT03653338

Locations: 🇺🇸
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

Autologous Stem Cell Transplantation in Patients with Systemic Sclerosis

Phase 2

Recruiting

Conditions: Diffuse Sclerosis Systemic
Interstitial Lung Disease
Pulmonary Hypertension
Systemic Sclerosis

Interventions: Drug: Cyclophosphamide
Drug: Mesna
Drug: Rituximab
Drug: Alemtuzumab
Drug: Thiotepa
Drug: GM-CSF
Drug: Intravenous immunoglobulin
Radiation: Total Body Irradiation
Drug: Anti Thymocyte Globulin

First Posted Date: 2018-08-14

Last Posted Date: 2025-03-17

Lead Sponsor: Paul Szabolcs

Target Recruit Count: 8

Registration Number: NCT03630211

Locations: 🇺🇸
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

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