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Last Updated: January 14, 2025

CLINICAL TRIALS PROFILE FOR GLEEVEC


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All Clinical Trials for Gleevec

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00015834 ↗ STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia Completed National Cancer Institute (NCI) Phase 1/Phase 2 2001-05-01 Phase I/II trial to study the effectiveness of combining STI571 and chemotherapy in treating patients who have chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells
NCT00022737 ↗ Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Children With Acute Lymphoblastic Leukemia Completed National Cancer Institute (NCI) Phase 3 2002-10-01 This phase II trial is studying how well combination chemotherapy with or without donor peripheral stem cell transplant works in treating children with acute lymphoblastic leukemia. Giving combination chemotherapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
NCT00025246 ↗ Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery Completed National Cancer Institute (NCI) Phase 2 2001-09-01 This phase II trial is studying how well imatinib mesylate works in treating patients with gastrointestinal stromal tumor that was completely removed during surgery. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gleevec

Condition Name

Condition Name for Gleevec
Intervention Trials
Leukemia 30
Chronic Myelogenous Leukemia 14
Chronic Myeloid Leukemia 14
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Condition MeSH

Condition MeSH for Gleevec
Intervention Trials
Leukemia 97
Leukemia, Myeloid 79
Leukemia, Myelogenous, Chronic, BCR-ABL Positive 78
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Clinical Trial Locations for Gleevec

Trials by Country

Trials by Country for Gleevec
Location Trials
United States 684
Canada 54
China 39
Australia 37
United Kingdom 26
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Trials by US State

Trials by US State for Gleevec
Location Trials
Texas 69
California 48
New York 40
Pennsylvania 34
Illinois 30
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Clinical Trial Progress for Gleevec

Clinical Trial Phase

Clinical Trial Phase for Gleevec
Clinical Trial Phase Trials
Phase 4 3
Phase 3 18
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Gleevec
Clinical Trial Phase Trials
Completed 160
Terminated 39
Recruiting 12
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Clinical Trial Sponsors for Gleevec

Sponsor Name

Sponsor Name for Gleevec
Sponsor Trials
National Cancer Institute (NCI) 77
M.D. Anderson Cancer Center 34
Novartis 34
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Sponsor Type

Sponsor Type for Gleevec
Sponsor Trials
Other 222
Industry 127
NIH 82
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Gleevec: A Revolutionary Drug in Cancer Treatment

Introduction to Gleevec

Gleevec, also known as imatinib, is a groundbreaking tyrosine kinase inhibitor that has transformed the treatment landscape for certain types of cancer, particularly chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). Since its FDA approval in 2001, Gleevec has been hailed as a "miracle cure" due to its unprecedented success rates and targeted approach to cancer therapy[1][3].

Clinical Trials and Approval

The journey of Gleevec began with its first clinical trials in 1998, which yielded astonishing results. The drug, initially known as STI571, was developed by Dr. Lydon and identified by Dr. Druker as exceptionally effective against CML cells. These early trials demonstrated a high success rate, earning Gleevec the name "wonder drug." The FDA approved Gleevec for commercial use in 2001, marking a significant milestone in cancer treatment[1].

Long-Term Efficacy

Follow-up studies have consistently shown the long-term efficacy of Gleevec. A study published in 2017 by the New England Journal of Medicine revealed that ten years after diagnosis, CML patients treated with Gleevec had an estimated survival rate of 83.3%. This confirms the remarkable long-term effectiveness of the drug[1].

Recent Clinical Trials

A recent clinical trial conducted in France emphasized the importance of uninterrupted Gleevec treatment for advanced GIST. The trial showed that stopping imatinib treatment had a detrimental effect on drug resistance and survival, highlighting the need for continuous therapy until the disease progresses[4].

Mechanism of Action

Gleevec works by inhibiting the BCR-ABL tyrosine kinase, a protein responsible for the uncontrolled proliferation of cancer cells in CML. Unlike traditional chemotherapy, which affects both healthy and cancerous cells, Gleevec selectively targets cancerous cells, leading to fewer side effects and improved quality of life for patients[3].

Market Analysis

Market Size and Forecast

The Gleevec market has shown substantial growth since its introduction. As of 2023, the market size was valued at $344 million and is projected to reach $644.7 million by 2031, growing at a compound annual growth rate (CAGR) of 8.29% during the forecast period 2024-2031[2].

Key Drivers

Several factors are driving the growth of the Gleevec market:

  • Increasing Cancer Incidence: The rising incidence of CML and other cancers, particularly among aging populations and due to lifestyle choices, is a key driver for the Gleevec market[2][3].
  • Advancements in Oncology: Continuous innovations in targeted therapies and precision medicine have improved the understanding of CML and its treatment landscape, solidifying Gleevec’s position in clinical guidelines[2][3].
  • Regulatory Approvals: Ongoing approvals and new indications for Gleevec further enhance its market presence[3].
  • Increased Healthcare Expenditure: Growing awareness and proactive screening programs for cancer encourage earlier diagnosis and treatment, increasing the demand for effective treatments like Gleevec[2].

Geographic Dynamics

The Gleevec market is influenced by regional dynamics:

  • North America: Led by the United States, this region is the largest market for Gleevec due to its advanced healthcare infrastructure, higher prevalence of CML, and significant investment in research and development[2].
  • Europe: The European Medicines Agency (EMA) has facilitated swift regulatory approvals, making countries like Germany, France, and the UK key contributors to the market[2].
  • Asia-Pacific: This region is witnessing rapid growth driven by increasing cancer incidence, improving healthcare access, and rising patient awareness[2].

Market Challenges

Despite its success, the Gleevec market faces several challenges:

  • Limited Indications: Gleevec’s applicability is narrow compared to newer therapies with broader uses, confining its potential patient pool and market reach[2].
  • Adverse Effects and Resistance: The emergence of adverse effects and drug resistance can impact the long-term efficacy of Gleevec, necessitating ongoing research into combination therapies and new formulations[2][3].

Future Outlook

The future of the Gleevec market looks promising, driven by several factors:

  • Advancements in Oncology: Ongoing research and development in targeted therapies and precision medicine are expected to maintain a steady growth rate for the Gleevec market[3].
  • Combination Therapies: Exploring combination therapies involving Gleevec and other targeted agents can enhance efficacy and reduce resistance[3].
  • Strategic Partnerships: Collaborations between pharmaceutical companies and research institutions aim to develop new formulations and delivery methods, improving patient adherence and outcomes[3].

Economic Impact

Gleevec has a significant economic impact by improving treatment outcomes and reducing overall healthcare costs associated with advanced-stage cancers. Effective treatment leads to a decrease in hospitalizations and the need for more intensive treatments and interventions[3].

Key Takeaways

  • Clinical Success: Gleevec has demonstrated remarkable long-term efficacy in treating CML and GIST.
  • Market Growth: The Gleevec market is projected to grow significantly, driven by increasing cancer incidence and advancements in oncology.
  • Targeted Therapy: Gleevec’s targeted approach has revolutionized cancer treatment, offering fewer side effects and improved patient outcomes.
  • Future Prospects: The market is expected to maintain a steady growth rate, with ongoing research and development driving new indications and combination therapies.

FAQs

1. What is Gleevec primarily used for?

Gleevec is primarily used to treat chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST)[3].

2. How does Gleevec work?

Gleevec works by inhibiting the BCR-ABL tyrosine kinase, which is responsible for the uncontrolled growth of cancer cells in CML[3].

3. What are the key drivers of the Gleevec market?

Key drivers include increasing cancer incidence, advancements in oncology, regulatory approvals, and increased healthcare expenditure[2][3].

4. What are the challenges facing the Gleevec market?

Challenges include limited indications, adverse effects, and drug resistance, as well as competition from newer therapies with broader uses[2].

5. What is the future outlook for the Gleevec market?

The market is expected to grow at a CAGR of approximately 5-7% over the next five years, driven by advancements in oncology and increasing cancer diagnoses[3].

Sources

  1. Studypages: "Cancer 'Wonder Drug' Still Effective Decades After Discovery—Are There Others Like It?"
  2. Verified Market Research: "Gleevec Market Size, Scope, Growth, Trends and Forecast"
  3. Market Research Intellect: "Gleevec Market Growth Transforming Cancer Treatment and Patient Lives"
  4. National Cancer Institute: "Trial Supports Uninterrupted Use of Imatinib for Some Gastrointestinal Stromal Tumors"
  5. Market Research Reports Inc.: "Gleevec - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030"

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