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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR CLOLAR


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All Clinical Trials for Clolar

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00067028 ↗ Clofarabine Combinations in Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS) and Myeloid Blast Phase Chronic Myeloid Leukemia (CML) Completed Genzyme, a Sanofi Company Phase 2 2003-12-01 The goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with Acute Myeloid Leukemia, high-grade MDS, or myeloid blast phase of Chronic Myeloid Leukemia who have relapsed following their initial therapy.
NCT00067028 ↗ Clofarabine Combinations in Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS) and Myeloid Blast Phase Chronic Myeloid Leukemia (CML) Completed M.D. Anderson Cancer Center Phase 2 2003-12-01 The goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with Acute Myeloid Leukemia, high-grade MDS, or myeloid blast phase of Chronic Myeloid Leukemia who have relapsed following their initial therapy.
NCT00081887 ↗ Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia Terminated Genzyme, a Sanofi Company Phase 1 2004-05-01 Primary Objectives: 1. To determine the maximum tolerated dose (MTD) of clofarabine in Chronic Lymphocytic Leukemia (CLL). 2. To determine the toxicity profile of clofarabine in CLL. 3. To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile of clofarabine in CLL.
NCT00081887 ↗ Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia Terminated M.D. Anderson Cancer Center Phase 1 2004-05-01 Primary Objectives: 1. To determine the maximum tolerated dose (MTD) of clofarabine in Chronic Lymphocytic Leukemia (CLL). 2. To determine the toxicity profile of clofarabine in CLL. 3. To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile of clofarabine in CLL.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Clolar

Condition Name

Condition Name for Clolar
Intervention Trials
Leukemia 21
Acute Myeloid Leukemia 18
Myelodysplastic Syndrome 12
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities 8
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Condition MeSH

Condition MeSH for Clolar
Intervention Trials
Leukemia 54
Leukemia, Myeloid, Acute 39
Leukemia, Myeloid 36
Myelodysplastic Syndromes 23
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Clinical Trial Locations for Clolar

Trials by Country

Trials by Country for Clolar
Location Trials
United States 290
Canada 16
Australia 5
India 2
New Zealand 2
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Trials by US State

Trials by US State for Clolar
Location Trials
Texas 32
Washington 15
California 12
Tennessee 11
New York 11
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Clinical Trial Progress for Clolar

Clinical Trial Phase

Clinical Trial Phase for Clolar
Clinical Trial Phase Trials
Phase 3 4
Phase 2 35
Phase 1/Phase 2 13
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Clinical Trial Status

Clinical Trial Status for Clolar
Clinical Trial Phase Trials
Completed 32
Terminated 14
Active, not recruiting 8
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Clinical Trial Sponsors for Clolar

Sponsor Name

Sponsor Name for Clolar
Sponsor Trials
M.D. Anderson Cancer Center 25
National Cancer Institute (NCI) 24
Genzyme, a Sanofi Company 20
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Sponsor Type

Sponsor Type for Clolar
Sponsor Trials
Other 76
Industry 28
NIH 25
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Clinical Trials, Market Analysis, and Projections for Clolar (Clofarabine)

Introduction

Clolar, also known as clofarabine, is a chemotherapy drug used primarily for the treatment of pediatric patients with relapsed or refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML). Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Experience

Patient Population and Dosage

In clinical trials, Clolar was administered to 115 pediatric patients with relapsed or refractory ALL or AML. The recommended dose was 52 mg/m² daily for 5 days, with a median number of cycles being 2 and a median cumulative dose of 540 mg during all cycles[1][4].

Adverse Reactions

Clinical trials highlighted several significant adverse reactions associated with Clolar. These include:

  • Hepatotoxicity: Severe and fatal hepatotoxicity, including hepatitis and hepatic failure, was observed. Grade 3-4 liver enzyme elevations were common, with AST elevated in 36% and ALT in 44% of patients[1][4].
  • Renal Toxicity: Grade 3 or 4 elevated creatinine occurred in 8% of patients, and acute renal failure was reported[4].
  • Cytokine Release Syndrome: This syndrome, which can progress to systemic inflammatory response syndrome (SIRS) with capillary leak syndrome, was reported in 2% of patients[1][4].
  • Enterocolitis: Serious and fatal enterocolitis, particularly within 30 days of treatment, was noted[4].
  • Skin Reactions: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases, were reported[4].

Monitoring and Management

Given the severe adverse reactions, close monitoring of patients is crucial. Early intervention and discontinuation of Clolar, along with supportive measures, are recommended to mitigate these risks[1][4].

Market Analysis

Current Market

Clolar is marketed under different names in various regions, such as Evoltra in Europe and Australia/New Zealand. The global market for Clolar was valued at approximately $459 million in 2024[5].

Market Projections

The global Clolar market is projected to grow, although specific growth rates and future valuations are not detailed in the available sources. However, the overall oncology market, particularly for pediatric and relapsed/refractory leukemias, is expected to see significant growth driven by increasing demand for effective treatments.

Drivers and Barriers

Drivers

  • Increasing Demand for Effective Treatments: The need for innovative and effective treatments in pediatric oncology drives the market for drugs like Clolar.
  • Advancements in Clinical Trials: Ongoing clinical trials and research efforts aim to enhance patient outcomes and safety, which can positively impact market growth[3].

Barriers

  • Adverse Reactions: The severe and potentially fatal side effects associated with Clolar can limit its adoption and market growth.
  • Regulatory Scrutiny: Stringent regulatory requirements and the need for continuous monitoring and safety data can pose challenges for market expansion[3].

Competitive Landscape

Oncology Market Trends

The broader oncology market, particularly for non-small cell lung cancer (NSCLC), is dominated by immunotherapies and targeted therapies. While Clolar is not directly part of this market, trends in oncology treatment can influence the overall demand for chemotherapy agents. For instance, the NSCLC market is expected to grow significantly, driven by the adoption of immune checkpoint inhibitors, which could indirectly impact the market for other oncology drugs[2].

Future Projections

Global Market Growth

The global Clolar market is expected to grow, driven by the increasing need for effective treatments in pediatric oncology. However, specific projections to 2030 indicate a moderate growth trajectory, with the market valued at around $459 million in 2024 and expected to increase over the coming years[5].

Regional Variations

Market growth will vary by region, with different regulatory environments and healthcare systems influencing adoption rates. For example, the European and Australian markets, where Clolar is marketed as Evoltra, may see different growth patterns compared to other regions.

Key Takeaways

  • Clinical Trials: Clolar has been tested in clinical trials involving pediatric patients with relapsed or refractory ALL and AML, highlighting significant adverse reactions.
  • Market Analysis: The global market for Clolar is valued at approximately $459 million in 2024 and is projected to grow.
  • Drivers and Barriers: The market is driven by the need for effective treatments but is limited by severe adverse reactions and regulatory scrutiny.
  • Future Projections: The market is expected to grow moderately over the coming years, influenced by regional variations and broader oncology market trends.

FAQs

What is Clolar used for?

Clolar (clofarabine) is used for the treatment of pediatric patients with relapsed or refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML)[1].

What are the common adverse reactions associated with Clolar?

Common adverse reactions include hepatotoxicity, renal toxicity, cytokine release syndrome, enterocolitis, and severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis[1][4].

How is Clolar administered?

Clolar is administered intravenously at a dose of 52 mg/m² daily for 5 days, with a median number of cycles being 2[1][4].

What is the current market value of Clolar?

The global Clolar market was valued at approximately $459 million in 2024[5].

What are the key drivers of the Clolar market?

The key drivers include the increasing demand for effective treatments in pediatric oncology and advancements in clinical trials[3].

What are the major barriers to the Clolar market?

Major barriers include severe adverse reactions and stringent regulatory requirements[3].

Sources

  1. Sanofi US: CLOLAR® (clofarabine) injection, for intravenous use.
  2. GlobalData: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
  3. Biospace: U.S. Clinical Trials Market Size Industry Analysis Report, 2033.
  4. FDA: CLOLAR (clofarabine) injection.
  5. QYResearch: Global Clolar Market Insights, Forecast to 2030.

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