CLINICAL TRIALS PROFILE FOR CHLORAMBUCIL

All Clinical Trials for Chlorambucil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003421 ↗	Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease	Completed	Medical Research Council	Phase 3	1998-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for advanced Hodgkin's disease. PURPOSE: Randomized phase III trial to compare different combination chemotherapy regimens in treating patients with advanced Hodgkin's disease.
NCT00003617 ↗	Chlorambucil Compared With No Further Therapy Following Anti-Helicobacter Therapy in Treating Patients With Low-Grade Lymphoma of the Stomach	Unknown status	Lymphoma Trials Office	Phase 3	1995-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known whether chlorambucil is more effective than observation in treating low-grade lymphoma of the stomach. PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of no further therapy following anti-Helicobacter therapy in treating patients with low-grade lymphoma of the stomach.
NCT00003639 ↗	Combination Chemotherapy With or Without Interferon Alfa in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma	Unknown status	Scotland and Newcastle Lymphoma Group	Phase 3	1993-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells and slow the growth of non-Hodgkin's lymphoma. It is not yet known whether combining more than one chemotherapy drug with interferon alfa is more effective than chemotherapy alone in treating patients with low-grade non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without interferon alfa in treating patients with low-grade non-Hodgkin's lymphoma.
NCT00004218 ↗	Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia	Completed	Medical Research Council	Phase 3	1999-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with newly diagnosed chronic lymphocytic leukemia.
NCT00004218 ↗	Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia	Completed	Leukemia Research Fund	Phase 3	1999-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with newly diagnosed chronic lymphocytic leukemia.
NCT00006250 ↗	Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma	Unknown status	Lymphoma Trials Office	Phase 3	2000-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.

Clinical Trial Conditions for Chlorambucil

Condition Name

Condition Name for Chlorambucil
Intervention	Trials
Chronic Lymphocytic Leukemia	23
Lymphoma	10
Lymphocytic Leukemia, Chronic	8
Leukemia	5

Condition MeSH

Condition MeSH for Chlorambucil
Intervention	Trials
Leukemia	46
Leukemia, Lymphoid	46
Leukemia, Lymphocytic, Chronic, B-Cell	46
Lymphoma	28

Clinical Trial Locations for Chlorambucil

Trials by Country

Trials by Country for Chlorambucil
Location	Trials
United States	228
United Kingdom	87
Italy	85
Spain	73
Australia	47

Trials by US State

Trials by US State for Chlorambucil
Location	Trials
California	17
Illinois	13
Texas	11
Washington	10
Ohio	9

Clinical Trial Progress for Chlorambucil

Clinical Trial Phase

Clinical Trial Phase for Chlorambucil
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	37
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Chlorambucil
Clinical Trial Phase	Trials
Completed	41
Unknown status	11
Active, not recruiting	11

Clinical Trial Sponsors for Chlorambucil

Sponsor Name

Sponsor Name for Chlorambucil
Sponsor	Trials
Hoffmann-La Roche	14
German CLL Study Group	8
Pharmacyclics LLC.	4

Sponsor Type

Sponsor Type for Chlorambucil
Sponsor	Trials
Other	83
Industry	71
NIH	3

Chlorambucil: Clinical Trials, Market Analysis, and Projections

Introduction

Chlorambucil, sold under the brand name Leukeran among others, is a chemotherapy medication widely used in the treatment of chronic lymphocytic leukemia (CLL), Hodgkin lymphoma, and non-Hodgkin lymphoma. This article provides an update on the clinical trials involving chlorambucil, a detailed market analysis, and projections for its future use.

Clinical Trials Update

ELEVATE-TN Study

One of the significant clinical trials involving chlorambucil is the ELEVATE-TN study (NCT02475681). This is a global, phase 3, multicenter, open-label study designed to evaluate the efficacy of different treatment regimens in patients with treatment-naive CLL.

• Treatment Arms: The study compares three treatment arms:

  • Arm A: Obinutuzumab in combination with chlorambucil.
  • Arm B: Acalabrutinib in combination with obinutuzumab.
  • Arm C: Acalabrutinib monotherapy[1][4].

• Primary Objective: The primary objective is to evaluate the efficacy of obinutuzumab in combination with chlorambucil compared to acalabrutinib in combination with obinutuzumab, based on progression-free survival (PFS) as assessed by an independent review committee (IRC)[1][4].

• Secondary Objectives: Secondary objectives include comparing the efficacy of these regimens in terms of IRC-assessed objective response rate (ORR), time to next treatment (TTNT), and overall survival (OS)[1][4].

• Enrollment and Status: The study enrolled 535 subjects across 142 study sites in 18 countries between September 2015 and February 2017. The study is currently in progress but not accepting new patients[1][4].

Key Findings

The results of the ELEVATE-TN study provide new evidence for the treatment of CLL, showing the efficacy of acalabrutinib used with or without obinutuzumab compared to the traditional chemoimmunotherapy regimen of obinutuzumab and chlorambucil. This study has significant implications for the treatment landscape of CLL, offering patients and clinicians more effective and potentially less toxic treatment options[1][4].

Market Analysis

Current Market Size and Growth

The global chlorambucil market is experiencing steady growth driven by the increasing demand for treatments of CLL, Hodgkin lymphoma, and non-Hodgkin lymphoma.

• Market Size: As of 2024, the global chlorambucil market size is estimated to be around $2538 million. It is projected to grow to $3459.9 million by 2030, at a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period[5].

• Regional Insights: The market growth is not uniform across all regions. Countries like the U.S., Canada, Mexico, Brazil, China, Japan, and South Korea are expected to be key contributors to the market growth due to their large patient populations and advanced healthcare systems[5].

Market Drivers

Several factors are driving the growth of the chlorambucil market:

• Increasing Incidence of Cancer: The rising incidence of cancers such as CLL, Hodgkin lymphoma, and non-Hodgkin lymphoma is a major driver. Chlorambucil remains a preferred treatment option for these conditions[5].

• Advancements in Healthcare: Improvements in healthcare infrastructure and the availability of advanced diagnostic tools are increasing the detection and treatment rates of these cancers, thereby boosting the demand for chlorambucil[5].

• Economic Factors: The global oncology drug market, which includes chlorambucil, is projected to reach $200 billion by 2025, indicating significant growth potential for established drugs like chlorambucil[2].

Competitive Landscape

The chlorambucil market is competitive, with several key players:

• Major Manufacturers: Companies such as GlaxoSmithKline, Aspen Pharmacare, IFET, Techni-Pharma, Excella GmbH, Medicare Pharma, Pharmatech, Techsphere, and Wael Pharmacy are among the major stakeholders in the global chlorambucil market[5].

• Market Positioning: These companies are focusing on expanding their market share through strategic partnerships, investments in research and development, and enhancing their distribution networks[5].

Projections and Future Outlook

Market Forecast

The global chlorambucil market is expected to continue its growth trajectory due to several factors:

• Increasing Demand: The demand for chlorambucil is anticipated to rise due to the growing incidence of cancers that it treats. This demand will be particularly high in regions with aging populations and improving healthcare systems[5].

• Technological Advancements: While chlorambucil remains an effective treatment, advancements in targeted therapies and immunotherapies may influence its market share. However, its established position and cost-effectiveness are likely to maintain its relevance[5].

• Economic Projections: The market is projected to grow at a CAGR of 5.3% from 2024 to 2030, reaching a market size of $3459.9 million by 2030[5].

Challenges and Opportunities

Despite the positive outlook, there are challenges and opportunities to consider:

• Competition from New Therapies: The emergence of new targeted therapies, such as ibrutinib and acalabrutinib, may pose a challenge to chlorambucil's market share. However, these therapies are often more expensive, making chlorambucil a cost-effective alternative[3].

• Regulatory Environment: Changes in regulatory policies and reimbursement structures can impact the market. Pharmaceutical companies need to be agile and responsive to these changes to maintain market competitiveness[5].

Key Takeaways

• Clinical Trials: The ELEVATE-TN study has provided significant insights into the efficacy of chlorambucil in combination with other treatments for CLL.
• Market Growth: The global chlorambucil market is expected to grow at a CAGR of 5.3% from 2024 to 2030.
• Competitive Landscape: The market is competitive with several major manufacturers, and companies need to focus on strategic partnerships and R&D to maintain market share.
• Future Outlook: Despite challenges from new therapies, chlorambucil is expected to remain a relevant treatment option due to its cost-effectiveness and established efficacy.

FAQs

What is the primary use of chlorambucil?

Chlorambucil is primarily used in the treatment of chronic lymphocytic leukemia (CLL), Hodgkin lymphoma, and non-Hodgkin lymphoma.

What is the current market size of chlorambucil?

As of 2024, the global chlorambucil market size is estimated to be around $2538 million.

What is the projected growth rate of the chlorambucil market?

The global chlorambucil market is projected to grow at a CAGR of 5.3% from 2024 to 2030.

Which clinical trial is significant for chlorambucil?

The ELEVATE-TN study (NCT02475681) is a significant clinical trial that compares the efficacy of chlorambucil in combination with obinutuzumab to other treatment regimens for CLL.

Who are the major manufacturers of chlorambucil?

Major manufacturers include GlaxoSmithKline, Aspen Pharmacare, IFET, Techni-Pharma, Excella GmbH, Medicare Pharma, Pharmatech, Techsphere, and Wael Pharmacy.

Sources

1. ClinicalTrials.gov: Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL.
2. Verified Market Reports: Chlorambucil Market Size, Share, Scope, Trends And Forecast 2030.
3. Blood Advances: Cost-effectiveness of ibrutinib as first-line therapy for chronic lymphocytic leukemia.
4. AstraZeneca Clinical Trials: Acalabrutinib, Obinutuzumab and Chlorambucil in treatment naïve CLL.
5. QYResearch: Global Chlorambucil Market Insights, Forecast to 2030.