CLINICAL TRIALS PROFILE FOR IMATINIB MESYLATE

All Clinical Trials for IMATINIB MESYLATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004932 ↗	STI571 in Treating Patients With Recurrent Leukemia	Completed	National Cancer Institute (NCI)	Phase 1	2002-01-01	RATIONALE: Imatinib mesylate may interfere with the growth of cancer cells and may be an effective treatment for leukemia. PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent leukemia.
NCT00004932 ↗	STI571 in Treating Patients With Recurrent Leukemia	Completed	Children's Oncology Group	Phase 1	2002-01-01	RATIONALE: Imatinib mesylate may interfere with the growth of cancer cells and may be an effective treatment for leukemia. PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent leukemia.
NCT00002514 ↗	Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission	Completed	Medical Research Council	Phase 3	1993-04-01	RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.
NCT00002514 ↗	Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission	Completed	National Cancer Institute (NCI)	Phase 3	1993-04-01	RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.
NCT00002514 ↗	Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission	Completed	Eastern Cooperative Oncology Group	Phase 3	1993-04-01	RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.

Clinical Trial Conditions for IMATINIB MESYLATE

Condition Name

Condition Name for IMATINIB MESYLATE
Intervention	Trials
Leukemia	58
Gastrointestinal Stromal Tumor	23
Chronic Myeloid Leukemia	18
Gastrointestinal Stromal Tumors	14

Condition MeSH

Condition MeSH for IMATINIB MESYLATE
Intervention	Trials
Leukemia	137
Leukemia, Myelogenous, Chronic, BCR-ABL Positive	105
Leukemia, Myeloid	101
Gastrointestinal Stromal Tumors	54

Clinical Trial Locations for IMATINIB MESYLATE

Trials by Country

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Trials by Country for IMATINIB MESYLATE
Location	Trials
United States	962
Canada	73
Australia	53
Italy	48
United Kingdom	47

Trials by US State

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Trials by US State for IMATINIB MESYLATE
Location	Trials
Texas	82
California	66
New York	55
Pennsylvania	46
Illinois	45

Clinical Trial Progress for IMATINIB MESYLATE

Clinical Trial Phase

Clinical Trial Phase for IMATINIB MESYLATE
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	34
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for IMATINIB MESYLATE
Clinical Trial Phase	Trials
Completed	235
Terminated	58
Unknown status	25

Clinical Trial Sponsors for IMATINIB MESYLATE

Sponsor Name

Sponsor Name for IMATINIB MESYLATE
Sponsor	Trials
National Cancer Institute (NCI)	111
Novartis Pharmaceuticals	52
Novartis	44

Sponsor Type

Sponsor Type for IMATINIB MESYLATE
Sponsor	Trials
Other	340
Industry	174
NIH	116

Imatinib Mesylate: Clinical Trials, Market Analysis, and Projections

Introduction to Imatinib Mesylate

Imatinib mesylate, commonly known by the brand name Gleevec, is a tyrosine kinase inhibitor used primarily in the treatment of certain types of cancer, including chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL) with Philadelphia chromosome positivity, and gastrointestinal stromal tumors (GIST)[1][4].

Clinical Trials Update

Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

One significant clinical trial, AALL1631, is a randomized phase III trial that investigates the efficacy of imatinib mesylate in combination with chemotherapy for patients with newly diagnosed Philadelphia chromosome positive ALL. This trial aims to determine whether the addition of imatinib mesylate to standard chemotherapy improves treatment outcomes for these patients. The trial includes patients aged 2 to 21 years and evaluates the drug's ability to block enzymes necessary for cancer cell growth, potentially leading to better treatment outcomes[1].

Treatment of Chronic Myeloid Leukemia

In the context of CML, clinical trials are ongoing to optimize treatment strategies. For instance, a study at Mayo Clinic evaluates the effectiveness of switching from imatinib to dasatinib in patients with CP-CML who have a BCR-ABL transcript level greater than 10% after 3 months of imatinib treatment. This study aims to determine if early switching to dasatinib can achieve a higher rate of major molecular response (MMR) compared to continued imatinib treatment[4].

Combination Therapies

Another study examines the combination of pembrolizumab with dasatinib, imatinib mesylate, or nilotinib in treating patients with CML and persistent minimal residual disease. This trial assesses whether the addition of pembrolizumab, a monoclonal antibody, can enhance the efficacy of these tyrosine kinase inhibitors in controlling cancer cell growth and spread[4].

Market Analysis

Global Market Size and Growth

The global imatinib mesylate market has been growing steadily. As of 2018, the market size was valued at a significant figure, and it is projected to expand at a compound annual growth rate (CAGR) from 2019 to 2025. The market is driven by increasing demand for effective treatments for CML, GIST, and other related conditions[2][5].

Key Players

The market is dominated by several key players, including Novartis (GLEEVEC), Cayman Chemical, Sichuan Xieli, Nanjing Kaihua Chemical, and Zhengda Tianqing. These companies play a crucial role in the production, distribution, and research and development of imatinib mesylate[5].

Market Segmentation

The imatinib mesylate market is segmented by type (99% purity, 98% purity, and other) and by application (CML, GIST, and other conditions). This segmentation helps in understanding the specific demands and trends within different segments of the market[5].

Regional Analysis

The market is analyzed across various regions, including the USA, EU, Japan, and China. China, in particular, has seen significant growth in both the import and export of imatinib mesylate, reflecting the country's increasing role in the global pharmaceutical market[2].

Market Projections

Forecast to 2030

The global imatinib mesylate market is anticipated to continue its growth trajectory, reaching a projected value by 2030. This growth is expected to be driven by ongoing research, increasing incidence of target diseases, and the expanding need for effective cancer treatments[5].

Production and Consumption

The production and consumption of imatinib mesylate are expected to rise, with key countries contributing significantly to the global capacity and production. The market forecast includes detailed analyses of production value, gross margin, and supply and consumption trends from 2024 to 2029[2].

Economic Impact

The market is influenced by global and Chinese macroeconomic environments. Factors such as economic growth, healthcare policies, and regulatory changes can impact the demand and supply dynamics of imatinib mesylate. The market analysis includes proposals for new projects, market entry strategies, and countermeasures for economic impacts[2].

Industry Dynamics

Market News and Developments

The imatinib mesylate market is dynamic, with ongoing developments and news influencing market trends. For example, advancements in biosimilar approvals and collaborations between pharmaceutical companies can affect market competition and growth[3].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as stringent regulatory requirements, patent expirations, and competition from generic and biosimilar products. However, opportunities exist in the form of expanding therapeutic applications, increasing demand for personalized medicine, and advancements in manufacturing technologies[2].

Key Takeaways

• Clinical Trials: Ongoing trials like AALL1631 and studies at Mayo Clinic are optimizing imatinib mesylate's use in treating various leukemias.
• Market Growth: The global imatinib mesylate market is projected to grow significantly by 2030, driven by increasing demand and research efforts.
• Key Players: Novartis, Cayman Chemical, Sichuan Xieli, Nanjing Kaihua Chemical, and Zhengda Tianqing are major players in the market.
• Market Segmentation: The market is segmented by type and application, with CML and GIST being primary applications.
• Regional Analysis: China and other regions are seeing significant growth in production and consumption.

FAQs

What is imatinib mesylate used for?

Imatinib mesylate is primarily used to treat chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL) with Philadelphia chromosome positivity, and gastrointestinal stromal tumors (GIST).

What are the key players in the imatinib mesylate market?

The key players include Novartis (GLEEVEC), Cayman Chemical, Sichuan Xieli, Nanjing Kaihua Chemical, and Zhengda Tianqing.

What is the projected growth of the imatinib mesylate market?

The global imatinib mesylate market is anticipated to grow significantly by 2030, driven by increasing demand and ongoing research efforts.

What are the main applications of imatinib mesylate?

The main applications are in the treatment of CML, GIST, and other related conditions.

How does imatinib mesylate work?

Imatinib mesylate works by blocking some of the enzymes needed for cancer cell growth, thereby stopping the growth of cancer cells.

Sources

1. AALL1631: International Phase 3 trial in Philadelphia chromosome ... - Cincinnati Children's Hospital Medical Center.
2. Imatinib Mesylate Market Size, Share, Trend and Forcarst to 2025 - Prof Research.
3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - BioSpace.
4. Chronic Myelogenous Leukemia Clinical Trials - Mayo Clinic.
5. Global Imatinib Mesylate Market Research ... - Valuates Reports.