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DRUG:

thiotepa

i
Other names: DSP-1958
Company:
Generic mfg.
Drug class:
DNA synthesis inhibitor, Alkylating agent
Related drugs:
3d
NCI-2017-02205: Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov)
P2, N=35, Recruiting, Fred Hutchinson Cancer Center | N=20 --> 35 | Trial completion date: Oct 2026 --> Mar 2027 | Trial primary completion date: Dec 2024 --> Mar 2025
Enrollment change • Trial completion date • Trial primary completion date
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • CD34 (CD34 molecule) • HLA-B (Major Histocompatibility Complex, Class I, B)
|
cyclophosphamide • fludarabine IV • thiotepa • dilanubicel (DVX101)
8d
New P2 trial
|
CD34 (CD34 molecule)
|
carmustine • melphalan • thiotepa
12d
New trial
|
thiotepa
16d
Trial initiation date
|
melphalan • fludarabine IV • thiotepa • Orca-T
18d
Intensified alkylating chemotherapy for patients with oligometastatic breast cancer harboring homologous recombination deficiency: Primary outcomes from the randomized phase III OLIGO study. (PubMed, Eur J Cancer)
The entire study population experienced long-term survival, with median OS well over five years. IACT compared to CDCT did not improve outcome in patients with OMBC harboring study-defined HRD. The optimal therapy for patients with OMBC requires further study.
P3 data • Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • HRD (Homologous Recombination Deficiency)
|
HR positive • HER-2 negative • HRD
|
carboplatin • cyclophosphamide • thiotepa
1m
Trial completion date
|
cisplatin • carboplatin • cyclophosphamide • etoposide IV • vincristine • thiotepa • Neupogen (filgrastim)
1m
NCI-2018-03732: Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (clinicaltrials.gov)
P2, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2024 --> Sep 2025
Trial completion date
|
MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • IL6 (Interleukin 6) • CXCL9 (Chemokine (C-X-C motif) ligand 9)
|
MYCN amplification • IL6 expression
|
cisplatin • carboplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • Leukine (sargramostim) • dexrazoxane
1m
New P2 trial
|
Brukinsa (zanubrutinib) • thiotepa • methotrexate IV
1m
Trial completion date
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • CD34 (CD34 molecule) • HLA-B (Major Histocompatibility Complex, Class I, B)
|
cyclophosphamide • fludarabine IV • thiotepa • dilanubicel (DVX101)
1m
Enrollment closed • Enrollment change
|
Rituxan (rituximab) • cyclophosphamide • Blincyto (blinatumomab) • sirolimus • melphalan • fludarabine IV • mesna • thiotepa • Neupogen (filgrastim)
2ms
New P2 trial
|
cyclophosphamide • thiotepa • busulfan
2ms
Long-term outcome of the Milano-HART strategy for high-risk medulloblastoma, including the impact of molecular subtype. (PubMed, Neuro Oncol)
This strategy, partly adopted in the ongoing SIOPE protocol,confirmed improved EFS and OS over previously reported outcomes in all high-risk categories;SHH tumors appeared the most aggressive.
Journal
|
TP53 (Tumor protein P53) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
TP53 mutation • MYCN amplification
|
carboplatin • cyclophosphamide • etoposide IV • methotrexate • thiotepa • methotrexate IV
2ms
Thiotepa, fludarabine plus busulfan regimen as conditioning regimen prior to allo-HSCT for adult acute lymphoblastic leukemia:a prospective,single-arm, phase 2 study (ChiCTR2400088533)
P2, N=80, Not yet recruiting, The First Affiliated Hospital, College of Medicine, Zhejiang University; The First Affiliated Hospital, College of Medicine, Zhejiang University
New P2 trial
|
fludarabine IV • thiotepa • busulfan
3ms
Reduced Intensity Transplantation for Severe Sickle Cell Disease (clinicaltrials.gov)
P2, N=40, Suspended, St. Jude Children's Research Hospital | Trial completion date: Jul 2025 --> Aug 2027 | Trial primary completion date: Jul 2024 --> Aug 2026
Trial completion date • Trial primary completion date
|
cyclophosphamide • Campath (alemtuzumab) • sirolimus • hydroxyurea • thiotepa • plerixafor
3ms
New P2 trial • Combination therapy
|
thiotepa
4ms
Trial completion date • Trial primary completion date
|
Rituxan (rituximab) • cyclophosphamide • Blincyto (blinatumomab) • sirolimus • melphalan • fludarabine IV • mesna • thiotepa • Neupogen (filgrastim)
4ms
Enrollment closed
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
|
etoposide IV • melphalan • fludarabine IV • thiotepa • cyclosporin A microemulsion
4ms
Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases (clinicaltrials.gov)
P2, N=54, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: Oct 2025 --> Oct 2032 | Trial primary completion date: Oct 2024 --> Oct 2031
Trial completion date • Trial primary completion date
|
KMT2A (Lysine Methyltransferase 2A) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B)
|
cyclophosphamide • fludarabine IV • thiotepa • cyclosporin A microemulsion
4ms
New Combination of Chemoimmunotherapy for Systemic B-cell Lymphoma With Central Nervous System Involvement (clinicaltrials.gov)
P2, N=76, Completed, International Extranodal Lymphoma Study Group (IELSG) | Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Mar 2024
Trial completion • Trial completion date
|
carboplatin • Rituxan (rituximab) • ifosfamide • etoposide IV • carmustine • thiotepa
4ms
Enrollment open • Post-transplantation
|
cyclophosphamide • clofarabine • fludarabine IV • thiotepa • busulfan
4ms
Intensive Conditioning withTHI/Bu/Flu/Ara-C in Allo-HSCT for Myeloid Malignancies With Extramedullary Involvement (clinicaltrials.gov)
P=N/A, N=50, Recruiting, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting --> Recruiting
Enrollment open
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
|
cytarabine • fludarabine IV • thiotepa • busulfan
4ms
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma (clinicaltrials.gov)
P2, N=12, Recruiting, Masonic Cancer Center, University of Minnesota | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Jul 2024 --> Oct 2025
Trial completion date • Trial primary completion date
|
CD34 (CD34 molecule)
|
carboplatin • cyclophosphamide • etoposide IV • melphalan • thiotepa
4ms
NTRK-fused central nervous system tumours: clinicopathological and genetic insights and response to TRK inhibitors. (PubMed, Acta Neuropathol Commun)
Four patients received adjuvant TRK inhibitor therapy (larotrectinib, repotrectinib, or entrectinib), among which three also received chemotherapy (n = 2) or proton therapy (n = 1). This patient had previously experienced relapse after the initial surgery and underwent autologous peripheral blood stem cell therapy with carboplatin/thiotepa and proton therapy. Conclusions Our study clarifies the distinct differences in the pathology and TRK inhibitor response between LGG and HGG with NTRK fusions.
Journal
|
TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • TERT (Telomerase Reverse Transcriptase) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • MDM4 (The mouse double minute 4) • TPM3 (Tropomyosin 3) • TFG (Trafficking From ER To Golgi Regulator) • FKBP15 (FKBP Prolyl Isomerase 15) • KANK1 (KN Motif And Ankyrin Repeat Domains 1) • NTRK (Neurotrophic receptor tyrosine kinase) • SPECC1L (Sperm Antigen With Calponin Homology And Coiled-Coil Domains 1 Like) • GKAP1 (G Kinase Anchoring Protein 1) • KIF5A (Kinesin Family Member 5A)
|
carboplatin • Vitrakvi (larotrectinib) • Rozlytrek (entrectinib) • Augtyro (repotrectinib) • thiotepa
4ms
A Phase II Pediatric Study of a Graft-VS.-Host Disease (GVHD) Prophylaxis Regimen With no Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies (clinicaltrials.gov)
P2, N=3, Terminated, St. Jude Children's Research Hospital | N=32 --> 3 | Trial completion date: Apr 2027 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Apr 2026 --> May 2024; Principal Investigator left institution
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
|
Jakafi (ruxolitinib) • cyclophosphamide • fludarabine IV • mesna • thiotepa • busulfan • cyclosporine
5ms
TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) for AutoSCT in Lymphoma (clinicaltrials.gov)
P2, N=50, Completed, Sheba Medical Center | Active, not recruiting --> Completed | Trial completion date: Apr 2024 --> Jun 2024 | Trial primary completion date: Apr 2024 --> Jun 2024
Trial completion • Trial completion date • Trial primary completion date
|
CD34 (CD34 molecule)
|
cytarabine • etoposide IV • melphalan • thiotepa
5ms
CD34+ Transplants for Leukemia and Lymphoma (clinicaltrials.gov)
P2, N=100, Not yet recruiting, Guenther Koehne | Trial completion date: Jun 2031 --> Oct 2031 | Trial primary completion date: Jun 2031 --> Oct 2031
Trial completion date • Trial primary completion date
|
CD34 (CD34 molecule)
|
cyclophosphamide • melphalan • fludarabine IV • thiotepa • busulfan
5ms
Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation (clinicaltrials.gov)
P2, N=40, Completed, Case Comprehensive Cancer Center | Trial completion date: Jun 2025 --> Jun 2024 | Active, not recruiting --> Completed
Trial completion • Trial completion date
|
FLT3 (Fms-related tyrosine kinase 3)
|
fludarabine IV • thiotepa • captisol-enabled melphalan
5ms
Memory T-cell enriched haploidentical transplantation with NK cell addback results in promising long-term outcomes: a phase II trial. (PubMed, J Hematol Oncol)
The combination of a CD45RA-depleted graft and NK-cell addback led to robust immune reconstitution maximizing the GVL effect and allowed for use of a submyeloablative, TBI-free conditioning regimen that was associated with excellent EFS resulting in promising long-term outcomes in this high-risk population. The trial is registered at ClinicalTrials.gov (NCT01807611).
P2 data • Journal
|
CD34 (CD34 molecule)
|
cyclophosphamide • sirolimus • melphalan • fludarabine IV • thiotepa
5ms
Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS (clinicaltrials.gov)
P2, N=324, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2027
Trial completion date • Trial primary completion date
|
KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • DNMT3A (DNA methyltransferase 1) • NF1 (Neurofibromin 1) • RUNX1 (RUNX Family Transcription Factor 1) • ASXL1 (ASXL Transcriptional Regulator 1) • PTPN1 (Protein Tyrosine Phosphatase Non-Receptor Type 1)
|
Venclexta (venetoclax) • cladribine • fludarabine IV • thiotepa • busulfan
5ms
CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML (clinicaltrials.gov)
P2, N=7, Completed, Stanford University | Suspended --> Completed | N=20 --> 7 | Trial completion date: Feb 2026 --> Sep 2023 | Trial primary completion date: Feb 2025 --> Sep 2023
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
|
cyclophosphamide • fludarabine IV • thiotepa • busulfan
6ms
Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers (clinicaltrials.gov)
P2, N=1, Terminated, Fred Hutchinson Cancer Center | The study was originally intended to be multi-site but was only conducted at the lead site. Due to the rarity of the subject population & smaller # of enrolling sites, we were not able to reach accrual goals.
Enrollment change • Trial termination
|
cyclophosphamide • fludarabine IV • thiotepa • dilanubicel (DVX101)
6ms
Successful Treatment of Refractory or Relapsed Hepatoblastoma With Autologous Hematopoietic Stem Cell Transplantation in Children. (PubMed, J Pediatr Hematol Oncol)
This study suggests autologous HSCT as an effective treatment in pediatric patients with R/R hepatoblastoma. Nevertheless, future large-scale prospective studies are warranted.
Journal
|
AFP (Alpha-fetoprotein)
|
carboplatin • etoposide IV • topotecan • melphalan • thiotepa
6ms
NCI-2017-00614: Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant (clinicaltrials.gov)
P2, N=204, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
Trial completion date • Trial primary completion date • Post-transplantation
|
cyclophosphamide • fludarabine IV • thiotepa • busulfan
6ms
Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS (clinicaltrials.gov)
P2, N=324, Recruiting, M.D. Anderson Cancer Center | Active, not recruiting --> Recruiting | N=103 --> 324
Enrollment open • Enrollment change
|
KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • DNMT3A (DNA methyltransferase 1) • NF1 (Neurofibromin 1) • RUNX1 (RUNX Family Transcription Factor 1) • ASXL1 (ASXL Transcriptional Regulator 1) • PTPN1 (Protein Tyrosine Phosphatase Non-Receptor Type 1)
|
Venclexta (venetoclax) • cladribine • fludarabine IV • thiotepa • busulfan
6ms
Haematopoietic stem cell transplantation after reduced intensity conditioning in children and adolescents with chronic myeloid leukaemia: A prospective multicentre trial of the I-BFM Study Group. (PubMed, Br J Haematol)
This prospective multicentre trial evaluated the safety and the efficacy of a thiotepa/melphalan-based reduced intensity conditioning (RIC) haematopoietic stem cell transplantation (HSCT) in children and adolescents with chronic myeloid leukaemia (CML) in chronic phase (CP). At last follow-up, 31 patients are GvHD-free and have stopped immunosuppression. RIC HSCT following pretreatment with TKI is feasible and effective in children and adolescents with CP-CML with an excellent disease-free and TKI-free survival.
Journal
|
ABL1 (ABL proto-oncogene 1)
|
melphalan • thiotepa
6ms
HR MB-5: Study of Sequential High-dose Chemotherapy in Children With High Risk Medulloblastoma (clinicaltrials.gov)
P1/2, N=29, Terminated, Gustave Roussy, Cancer Campus, Grand Paris | Active, not recruiting --> Terminated
Trial termination
|
MYC (V-myc avian myelocytomatosis viral oncogene homolog) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
carboplatin • temozolomide • cyclophosphamide • etoposide IV • irinotecan • thiotepa
6ms
ABCD-NK: Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML (clinicaltrials.gov)
P1/2, N=48, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting
Enrollment open
|
melphalan • fludarabine IV • thiotepa • busulfan • plerixafor
6ms
VERITAS: Evaluation of 2 Intensification Treatment Strategies for Neuroblastoma Patients With a Poor Response to Induction (clinicaltrials.gov)
P2, N=34, Terminated, Gustave Roussy, Cancer Campus, Grand Paris | Trial completion date: Aug 2023 --> Mar 2024
Trial completion date • Metastases
|
temozolomide • irinotecan • topotecan • thiotepa
7ms
Trial initiation date
|
melphalan • fludarabine IV • thiotepa • Orca-T
7ms
Enrollment open • Surgery
|
ALK (Anaplastic lymphoma kinase) • TERT (Telomerase Reverse Transcriptase) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
|
cisplatin • carboplatin • temozolomide • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • irinotecan • vincristine • daunorubicin • topotecan • melphalan • thiotepa • Qarziba (dinutuximab beta) • Unituxin (dinutuximab) • dexrazoxane
7ms
Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML (clinicaltrials.gov)
P=N/A, N=37, Not yet recruiting, First Affiliated Hospital Xi'an Jiaotong University
New trial
|
fludarabine IV • thiotepa • busulfan • Duoenda (mitoxantrone liposomal)
7ms
Trial completion • Trial completion date • Surgery
|
cisplatin • carboplatin • cyclophosphamide • etoposide IV • vincristine • leucovorin calcium • thiotepa • Neupogen (filgrastim) • methotrexate IV