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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR LEUSTATIN


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All Clinical Trials for Leustatin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002805 ↗ Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Completed National Cancer Institute (NCI) Phase 2 1997-08-01 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 with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did not achieve first remission.
NCT00002805 ↗ Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Completed Children's Oncology Group Phase 2 1997-08-01 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 with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did not achieve first remission.
NCT00002833 ↗ Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia Completed National Cancer Institute (NCI) Phase 2 1994-10-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.
NCT00002833 ↗ Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia Completed M.D. Anderson Cancer Center Phase 2 1994-10-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Leustatin

Condition Name

Condition Name for Leustatin
Intervention Trials
Acute Myeloid Leukemia 14
Refractory Acute Myeloid Leukemia 7
Leukemia 7
Recurrent Acute Myeloid Leukemia 5
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Condition MeSH

Condition MeSH for Leustatin
Intervention Trials
Leukemia 28
Leukemia, Myeloid 26
Leukemia, Myeloid, Acute 24
Preleukemia 13
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Clinical Trial Locations for Leustatin

Trials by Country

Trials by Country for Leustatin
Location Trials
United States 98
Canada 10
Australia 6
Netherlands 1
Switzerland 1
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Trials by US State

Trials by US State for Leustatin
Location Trials
Texas 14
Washington 12
Wisconsin 4
Pennsylvania 3
Oregon 3
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Clinical Trial Progress for Leustatin

Clinical Trial Phase

Clinical Trial Phase for Leustatin
Clinical Trial Phase Trials
Phase 2 19
Phase 1/Phase 2 5
Phase 1 6
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Clinical Trial Status

Clinical Trial Status for Leustatin
Clinical Trial Phase Trials
Recruiting 14
Completed 10
Not yet recruiting 3
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Clinical Trial Sponsors for Leustatin

Sponsor Name

Sponsor Name for Leustatin
Sponsor Trials
National Cancer Institute (NCI) 21
M.D. Anderson Cancer Center 12
Fred Hutchinson Cancer Research Center 6
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Sponsor Type

Sponsor Type for Leustatin
Sponsor Trials
Other 31
NIH 21
Industry 7
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Clinical Trials, Market Analysis, and Projections for Leustatin

Introduction

Leustatin, also known as cladribine, is a nucleoside analog used in the treatment of various types of leukemia, including hairy cell leukemia (HCL) and chronic lymphocytic leukemia (CLL). Here, we will delve into the current state of clinical trials, market analysis, and future projections for Leustatin.

Clinical Trials Overview

Efficacy and Safety

Recent clinical trials have highlighted the efficacy and safety of Leustatin, particularly in the treatment of HCL. A Phase 2 trial combining sequential cladribine and rituximab in HCL patients showed promising results. Out of 139 patients enrolled, 133 achieved a complete response (CR) with 77% achieving measurable residual disease (MRD) negativity. The 10-year event-free survival (EFS) and overall survival (OS) rates were 86.7% and 91.1%, respectively[4].

Adverse Effects

While Leustatin is effective, it is associated with several adverse effects. Myelosuppression, including neutropenia, anemia, and thrombocytopenia, is a significant concern. These effects are usually reversible but require careful hematological monitoring, especially during the first 4 to 8 weeks after treatment initiation[1].

Serious Skin Reactions and Other Toxicities

Leustatin can also cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, particularly when administered with other drugs known to cause severe skin reactions. Additionally, high doses of Leustatin have been associated with acute nephrotoxicity and delayed onset neurotoxicity[1].

Market Analysis

Global Market Size and Growth

The global hairy cell leukemia treatment market, in which Leustatin is a key player, was valued at USD 102.1 million in 2023. It is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.4% from 2024 to 2030, reaching USD 147.6 million by 2030[5].

Regional Growth

North America and Europe are currently the leading regions in the adoption of Leustatin, driven by strong FDA and EMA support, respectively. However, the Asia-Pacific and Latin America regions are emerging as significant markets due to improved healthcare infrastructure and increasing awareness of HCL[5].

Competitive Landscape

The market for HCL treatments is competitive, with major players including Pfizer Inc, F. Hoffmann La Roche AG, Janssen Global Services, Emcure Pharmaceuticals, and others. The targeted therapy segment, which includes Leustatin, held the largest share of 32.5% in 2023 and is expected to grow at the fastest CAGR of 7.5% during the forecast period[5].

Market Projections

Increasing Demand for Targeted Therapies

The demand for targeted therapies like Leustatin is expected to rise due to their improved efficacy and safety profiles compared to traditional treatments. The approval of new therapies, such as Revumenib for advanced Acute Myeloid Leukemia (AML), further underscores the trend towards targeted treatments in the leukemia therapeutics market[2].

Growing Incidence of Leukemia

The rising incidence of leukemia, including HCL, is a significant driver for the market growth. According to the American Cancer Society, blood cancers, which include leukemia, account for about 10% of new cancer cases in the U.S., contributing to the increasing demand for effective treatments like Leustatin[2].

Government and Private Funding

Government initiatives and private funding for clinical trials and research in cancer therapeutics are also driving the market. These investments support the development of new treatments and improve patient outcomes, further boosting the market for drugs like Leustatin[3].

Key Takeaways

  • Efficacy and Safety: Leustatin has shown high efficacy in treating HCL, with significant complete response rates and long-term survival benefits.
  • Adverse Effects: Careful monitoring is required due to myelosuppression and other potential toxicities.
  • Market Growth: The global HCL treatment market is expected to grow at a CAGR of 5.4% from 2024 to 2030.
  • Regional Expansion: Emerging markets in Asia-Pacific and Latin America are driving growth.
  • Competitive Landscape: Major pharmaceutical companies are key players in the market, with a focus on targeted therapies.

FAQs

What is Leustatin used for?

Leustatin, or cladribine, is used primarily in the treatment of hairy cell leukemia (HCL) and chronic lymphocytic leukemia (CLL).

What are the common side effects of Leustatin?

Common side effects include myelosuppression (neutropenia, anemia, thrombocytopenia), fever, and potential serious skin reactions. High doses can lead to nephrotoxicity and neurotoxicity.

How effective is Leustatin in treating HCL?

Leustatin has shown high efficacy in HCL, with a complete response rate of 97% and long-term survival benefits in clinical trials.

What is the projected market growth for HCL treatments?

The global HCL treatment market is expected to grow at a CAGR of 5.4% from 2024 to 2030, reaching USD 147.6 million by 2030.

Which regions are driving the growth of the HCL treatment market?

North America and Europe are currently leading, but the Asia-Pacific and Latin America regions are emerging as significant markets due to improved healthcare infrastructure and increasing awareness.

Sources

  1. LEUSTATIN® 1 mg/mL solution for infusion - Medsafe
  2. Leukemia Therapeutics Market Analysis | 2024-2030 - NextMSC
  3. Global Clinical Trials Market Size, Top Share, Trends, Forecast by ... - StraitsResearch
  4. Long-term results of the sequential combination of cladribine and ... - PubMed
  5. Hairy Cell Leukemia Treatment Market Size Report, 2030 - Grand View Research

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