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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR THIOTEPA


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All Clinical Trials for Thiotepa

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001498 ↗ A Pilot Trial of Sequential Chemotherapy With Antimetabolite Induction, High-Dose Alkylating Agent Consolidation With Peripheral Blood Progenitor Cell Support, and Intensification With Paclitaxel and Doxorubicin for Patients With High-Risk Breast Ca Completed National Cancer Institute (NCI) Phase 2 1996-02-01 Stage III patients may begin therapy prior to or following surgery. Patients with undrainable significant third space fluid collection (e.g., pleural effusions, ascites) are entered directly on Consolidation. Patients receive induction chemotherapy with methotrexate and fluorouracil every 2 weeks for 4 courses. Patients then receive two 3-week courses of consolidation therapy with cyclophosphamide, followed by daily granulocyte colony-stimulating factor until completion of leukapheresis. Patients next receive myeloablative doses of thiotepa followed by stem cell rescue and granulocyte colony-stimulating factor. After hematopoietic reconstitution, patients receive 24-hour infusions of paclitaxel every 3 weeks for 4 doses, followed by doxorubicin or vinblastine every 3 weeks for 4 doses. Patients are then evaluated for additional therapy (surgery, radiotherapy, or hormonal therapy) as appropriate. Patients are followed every 3 months for 1 year, then every 6 months.
NCT00001561 ↗ Active Immunization of Sibling Bone Marrow Transplant Donors Against Purified Myeloma Protein of the Recipient Undergoing Allogeneic Bone Marrow Transplantation Completed National Cancer Institute (NCI) Phase 3 1996-11-01 Both patients and marrow donors are treated on Regimen A; patients then proceed to Regimen B. The following acronyms are used: ABM Allogeneic Bone Marrow BU Busulfan, NSC-750 CF Leucovorin calcium, NSC-3590 CTX Cyclophosphamide, NSC-26271 G-CSF Granulocyte Colony-Stimulating Factor (source not specified) GM-CSF Granulocyte-Macrophage Colony-Stimulating Factor (Hoechst/Immunex), NSC-613795 GVHD Graft-vs.-Host Disease Mesna Mercaptoethane sulfonate, NSC-113891 MTX Methotrexate, NSC-740 PP Unconjugated Myeloma Immunoglobulin plasma paraprotein, NSC-684150 PP-KLH Myeloma immunoglobulin plasma paraprotein vaccine, NSC-678327, with keyhole limpet hemocyanin TBI Total-Body Irradiation TSPA Thiotepa, NSC-6396 Regimen A (Donor and Patient): Vaccine Therapy with Immunoadjuvant. PP-KLH (individual myeloma immunoglobulin plasma paraprotein vaccine prepared from recipient's plasma paraprotein and conjugated with KLH); and PP; with GM-CSF. Regimen B (Patient): Myeloablative Radiotherapy and 2-Drug Combination Chemotherapy or 2-Drug Combination Myeloablative Chemotherapy followed by Hematopoietic Rescue with Growth Factor Support and GVHD Prophylaxis followed by Vaccine Therapy with Immunoadjuvant. TBI; and CTX/TSPA; or BU/CTX; followed by ABM; with G-CSF; and CYSP; MTX/CF; followed by PP-KLH; with GM-CSF.
NCT00002471 ↗ Combination Chemotherapy in Treating Patients With Acute B-Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma Completed Memorial Sloan Kettering Cancer Center Phase 2 1990-02-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have acute B-lymphoblastic leukemia or recurrent non-Hodgkin's lymphoma.
NCT00002508 ↗ Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors Completed Fox Chase Cancer Center Phase 1/Phase 2 1990-11-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have relapsed or recurrent germ cell cancer.
NCT00002508 ↗ Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors Completed Temple University Phase 1/Phase 2 1990-11-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have relapsed or recurrent germ cell cancer.
NCT00002515 ↗ Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer Completed Memorial Sloan Kettering Cancer Center Phase 2 1992-10-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with thiotepa, carboplatin, and topotecan followed by bone marrow transplantation in treating patients who have metastatic or progressive rare cancer.
NCT00002534 ↗ Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission Completed National Cancer Institute (NCI) Phase 3 1993-05-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of bone marrow transplantation using untreated or treated bone marrow in treating patients with acute leukemia in first or second remission.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Thiotepa

Condition Name

Condition Name for Thiotepa
Intervention Trials
Leukemia 33
Breast Cancer 28
Lymphoma 28
Myelodysplastic Syndromes 21
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Condition MeSH

Condition MeSH for Thiotepa
Intervention Trials
Leukemia 78
Myelodysplastic Syndromes 52
Preleukemia 49
Lymphoma 47
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Clinical Trial Locations for Thiotepa

Trials by Country

Trials by Country for Thiotepa
Location Trials
United States 785
Canada 59
Australia 24
United Kingdom 17
Italy 16
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Trials by US State

Trials by US State for Thiotepa
Location Trials
New York 67
Texas 39
Pennsylvania 37
Washington 34
California 34
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Clinical Trial Progress for Thiotepa

Clinical Trial Phase

Clinical Trial Phase for Thiotepa
Clinical Trial Phase Trials
Phase 4 1
Phase 3 24
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Thiotepa
Clinical Trial Phase Trials
Completed 101
Recruiting 58
Terminated 25
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Clinical Trial Sponsors for Thiotepa

Sponsor Name

Sponsor Name for Thiotepa
Sponsor Trials
National Cancer Institute (NCI) 86
Fred Hutchinson Cancer Research Center 21
Memorial Sloan Kettering Cancer Center 20
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Sponsor Type

Sponsor Type for Thiotepa
Sponsor Trials
Other 301
NIH 97
Industry 26
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Thiotepa: Clinical Trials, Market Analysis, and Projections

Introduction

Thiotepa, an alkylating agent, is a crucial chemotherapy drug used in the treatment of various cancers, including breast, ovarian, and bladder cancer. This article delves into the current clinical trials, market analysis, and future projections for thiotepa, highlighting its significance in oncology and its growing market presence.

Clinical Trials and Efficacy

Thiotepa in Relapsed or Refractory Primary Central Nervous System Lymphoma (rrPCNSL)

A recent multicenter phase 1/2 study investigated the use of thiotepa in combination with ifosfamide, etoposide, and rituximab (TIER) for treating rrPCNSL. The study found that 50 mg/m² of thiotepa could be safely delivered within the TIER regimen without encountering dose-limiting toxicities. The overall response rate was 52%, with a median progression-free survival of 3 months and overall survival of 5 months. This regimen, followed by autologous stem cell transplantation (ASCT), showed promising results with durable remissions in some patients[1].

Reduced Intensity Conditioning Regimens

Another clinical trial (NCT03342196) is examining the use of thiotepa in reduced intensity conditioning regimens for alternative donor transplants, such as double umbilical cord blood transplants and haplo-identical transplants. The regimen combines thiotepa with melphalan and fludarabine, aiming to confirm its safety and efficacy in patients with hematologic malignancies[4].

Market Analysis

Current Market Size and Growth

The thiotepa market was valued at USD 1.2 billion in 2023 and is projected to reach USD 2.6 billion by 2031, growing at a compound annual growth rate (CAGR) of 9.2% from 2024 to 2031. This growth is driven by the increasing incidence of cancer, advancements in oncology research, and the expanding use of thiotepa in various therapeutic applications[2][3].

Market Segmentation

The thiotepa market is segmented based on type (thiotepa injection, thiotepa powder, thiotepa tablets), application (cancer chemotherapy, oncology treatments, pharmaceutical industry), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). The report provides a detailed overview of market divisions, market perspectives, competition analysis, and corporate profiles, which are crucial for understanding the market dynamics[2].

Key Drivers of Growth

  • Increasing Cancer Incidence: The rising global incidence of cancer has led to a higher demand for effective treatment options, including thiotepa.
  • Advancements in Oncology Research: Innovations in drug delivery systems, combination therapies, and personalized medicine are enhancing the therapeutic potential of thiotepa.
  • Expanding Applications: Thiotepa's use in conditioning regimens prior to bone marrow transplants and its role in treating various cancers are expanding its market reach.
  • Rising Healthcare Spending: Increased healthcare spending and improving access to cancer therapies in developing nations are also driving the market growth[2][3].

Emerging Trends and Strategic Insights

Innovations in Drug Delivery Systems

Recent innovations in controlled-release formulations and targeted delivery methods are improving the efficacy of thiotepa while minimizing side effects. These advancements are expected to drive further growth in the thiotepa market[3].

Ongoing Clinical Trials and Research

Clinical trials are exploring new applications and combinations of thiotepa, including its potential use in treating other types of cancer and its effectiveness when combined with emerging therapies. These developments are likely to expand the drug’s market potential and application[3].

Strategic Partnerships and Collaborations

The market has seen a rise in strategic partnerships and collaborations aimed at advancing thiotepa research and improving treatment outcomes. These collaborations between pharmaceutical companies, research institutions, and healthcare providers are driving innovation and expanding the drug's market reach[3].

Merger and Acquisition Activity

Increased merger and acquisition activity within the pharmaceutical sector is aimed at consolidating positions, expanding portfolios, and enhancing research capabilities. This activity is expected to further strengthen the market position of thiotepa[3].

Future Projections

Market Growth Prognosis

The future of the thiotepa market looks promising, driven by ongoing advancements in cancer treatment, increasing demand in emerging markets, and a growing focus on innovation. As research continues to uncover new applications and improve the drug’s efficacy, thiotepa is set to play an increasingly vital role in oncology[3].

Regional Growth

Countries in the Asia-Pacific, Latin America, and the Middle East are experiencing significant growth in the demand for thiotepa due to improving healthcare infrastructure and increasing awareness about cancer treatment. This regional growth is expected to contribute substantially to the overall market expansion[3].

Key Takeaways

  • Thiotepa is a critical chemotherapy drug with growing applications in treating various cancers.
  • Clinical trials, such as the TIER regimen and reduced intensity conditioning regimens, have shown promising results.
  • The thiotepa market is projected to grow significantly, driven by increasing cancer incidence, advancements in oncology research, and expanding therapeutic applications.
  • Innovations in drug delivery systems and ongoing clinical trials are expected to further enhance the market growth.
  • Strategic partnerships and merger and acquisition activities are driving innovation and market expansion.

FAQs

What is Thiotepa used for?

Thiotepa is primarily used as a chemotherapy drug for treating cancers such as breast cancer, ovarian cancer, and bladder cancer. It works by interfering with the DNA in cancer cells, preventing their growth and spread[3].

What are the key drivers of the Thiotepa market growth?

The growth of the thiotepa market is driven by rising cancer incidence rates, advancements in cancer treatment, and increasing adoption in emerging markets[2][3].

What are the latest trends in the Thiotepa market?

Recent trends include innovations in drug delivery systems, ongoing clinical trials exploring new applications, and increased merger and acquisition activity within the pharmaceutical sector[3].

How does Thiotepa compare to other chemotherapy drugs?

Thiotepa is unique due to its ability to target specific cancer types and enhance the effectiveness of other anticancer drugs. Its role in combination chemotherapy regimens and conditioning regimens prior to bone marrow transplants underscores its importance in oncology[3].

What are the future projections for the Thiotepa market?

The thiotepa market is expected to reach USD 2.6 billion by 2031, growing at a CAGR of 9.2% from 2024 to 2031, driven by ongoing advancements in cancer treatment and increasing demand in emerging markets[2][3].

Sources

  1. Phase 1/2 Study of Thiotepa-Based Immunochemotherapy: PubMed, "A phase 1/2 study of thiotepa-based immunochemotherapy in relapsed or refractory primary central nervous system lymphoma," 2021.
  2. Thiotepa Market Size and Projections: Market Research Intellect, "Global Thiotepa Market," January 2025.
  3. Navigating the Thiotepa Market: Market Research Intellect, "Navigating the Thiotepa Market: Emerging Trends and Strategic Insights for Investors," September 2024.
  4. Clinical Trial: NCT03342196: My Cancer Genome, "Clinical Trial: NCT03342196 - My Cancer Genome," June 2021.
  5. Global Thiotepa API Market Research Report: QYResearch, "Global Thiotepa API Market Research Report 2024," 2024.

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