CLINICAL TRIALS PROFILE FOR ALEMTUZUMAB

All Clinical Trials for alemtuzumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00027560 ↗	Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-07-01	RATIONALE: Giving low doses of chemotherapy, such as melphalan and fludarabine, and a monoclonal antibody, such as alemtuzumab, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well fludarabine, melphalan, alemtuzumab, and peripheral stem cell transplant work in treating patients with hematologic cancer.
NCT00006390 ↗	Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	2001-02-01	RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Combining monoclonal antibody therapy, chemotherapy, radiation therapy, and peripheral stem cell transplantation may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of alemtuzumab plus peripheral stem cell transplantation in treating patients who have chronic lymphocytic leukemia.
NCT00006390 ↗	Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia	Completed	Eastern Cooperative Oncology Group	Phase 2	2001-02-01	RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Combining monoclonal antibody therapy, chemotherapy, radiation therapy, and peripheral stem cell transplantation may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of alemtuzumab plus peripheral stem cell transplantation in treating patients who have chronic lymphocytic leukemia.
NCT00004857 ↗	Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	2000-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in treating patients who have chronic lymphocytic leukemia.
NCT00004857 ↗	Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia	Completed	Alliance for Clinical Trials in Oncology	Phase 2	2000-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of fludarabine followed by alemtuzumab in treating patients who have chronic lymphocytic leukemia.
NCT00004143 ↗	Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes	Completed	David Rizzieri, MD	Phase 2	1999-09-01	RATIONALE: Although used primarily to treat malignant disorders of the blood, allogeneic stem cell transplantation can also cure a variety of non-cancerous, inherited or acquired disorders of the blood. Unfortunately, the conventional approach to allogeneic stem cell transplantation is a risky procedure. For some non-cancerous conditions, the risks of this procedure outweigh the potential benefits. This protocol is designed to test a new approach to allogeneic stem cell transplantation. It is hoped that this approach will be better suited for patients with non-cancerous blood and bone marrow disorders.

Clinical Trial Conditions for alemtuzumab

Condition Name

Condition Name for alemtuzumab
Intervention	Trials
Leukemia	37
Lymphoma	23
Sickle Cell Disease	23
Chronic Lymphocytic Leukemia	17

Condition MeSH

Condition MeSH for alemtuzumab
Intervention	Trials
Leukemia	82
Leukemia, Lymphoid	63
Leukemia, Lymphocytic, Chronic, B-Cell	50
Lymphoma	48

Clinical Trial Locations for alemtuzumab

Trials by Country

+

−

Trials by Country for alemtuzumab
Location	Trials
United States	506
United Kingdom	25
Germany	24
Canada	21
Spain	19

Trials by US State

+

−

Trials by US State for alemtuzumab
Location	Trials
Texas	42
Illinois	33
Maryland	32
New York	29
Ohio	27

Clinical Trial Progress for alemtuzumab

Clinical Trial Phase

Clinical Trial Phase for alemtuzumab
Clinical Trial Phase	Trials
Phase 4	20
Phase 3	15
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for alemtuzumab
Clinical Trial Phase	Trials
Completed	140
Terminated	55
Recruiting	43

Clinical Trial Sponsors for alemtuzumab

Sponsor Name

Sponsor Name for alemtuzumab
Sponsor	Trials
National Cancer Institute (NCI)	35
Genzyme, a Sanofi Company	22
Bayer	18

Sponsor Type

Sponsor Type for alemtuzumab
Sponsor	Trials
Other	368
Industry	91
NIH	62

Alemtuzumab: Clinical Trials, Market Analysis, and Projections

Introduction

Alemtuzumab, marketed under the brand name Lemtrada, is a monoclonal antibody used in the treatment of multiple sclerosis (MS) and certain types of leukemia. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Effectiveness and Safety

Multiple Sclerosis

In the context of MS, particularly for adults with highly active relapsing-remitting MS (RRMS), alemtuzumab has shown promising results. A systematic review of clinical trials and prospective comparative cohort studies indicated that alemtuzumab may result in a clinically important reduction in relapses compared to interferon beta-1a, a common first-line treatment[1].

However, the evidence is not without its limitations. The review highlighted uncertainty due to risk of bias, small sample sizes, and incomplete reporting. Despite these challenges, alemtuzumab has been identified as one of the high-efficacy treatments that may reduce relapses, disability, and key MRI lesions in patients with highly active RRMS[1].

Leukemia and Other Indications

Alemtuzumab is also being explored in other clinical contexts, such as in the treatment of certain leukemias. Cellectis has been conducting Phase I trials using alemtuzumab as part of a lymphodepletion regimen in combination with their CAR T-cell therapy, UCART22, for patients with relapsed/refractory B cell acute lymphoblastic leukemia (ALL). The FDA has granted alemtuzumab an orphan drug designation for this use, indicating positive preliminary efficacy and safety results[4].

Market Analysis

Current Market Size

The global market for multiple sclerosis therapies, which includes alemtuzumab, was valued at approximately USD 26.9 billion in 2023. Alemtuzumab itself was valued at around USD 2.5 billion in 2022, reflecting its significant presence in the MS treatment landscape[2][3].

Growth Projections

The multiple sclerosis therapies market is expected to grow at a compound annual growth rate (CAGR) of 3.7% from 2024 to 2032, reaching a projected value of USD 37.8 billion by 2032. This growth is driven by the development of innovative disease-modifying therapies (DMTs), including monoclonal antibodies like alemtuzumab[2].

Regional Markets

North America, particularly the United States and Canada, represents the largest market for multiple sclerosis therapies, including alemtuzumab. This is due to the high prevalence of MS in these regions and the advanced diagnostic and therapeutic technologies available[2].

Technological Advancements and R&D

Innovative Therapies

The development of novel DMTs is a key driver of the MS therapies market. Alemtuzumab, by targeting immune cells to prevent them from entering the central nervous system (CNS) and causing inflammation, exemplifies this innovation. Pharmaceutical companies are heavily investing in research to discover new targets and develop next-generation therapies, further expanding the therapeutic arsenal for MS[2].

Collaborations and Partnerships

Cellectis's partnership with AstraZeneca and Sanofi highlights the collaborative efforts in advancing cell and gene therapies. These partnerships are crucial for the development and commercialization of new treatments, including those involving alemtuzumab[4].

Challenges and Future Directions

Safety and Efficacy Concerns

Alemtuzumab is associated with significant safety concerns, including risks of autoimmunity, infusion reactions, and malignancies. It is currently available only through a restricted program due to these risks. Ongoing and future trials will need to carefully balance efficacy with safety to ensure the long-term viability of alemtuzumab as a treatment option[1][4].

Ongoing Trials

The TREAT-MS and DELIVER-MS trials, which are currently ongoing, aim to compare early, high-efficacy treatment strategies versus traditional escalation strategies. These trials may provide valuable insights into the optimal use of alemtuzumab and other high-efficacy treatments in the MS treatment paradigm[1].

Economic Evaluation

Further research is needed to address the gaps in clinical data and inform economic evaluations. This will be crucial for jurisdictions considering reimbursement criteria for alemtuzumab and other high-efficacy treatments in the first-line setting for highly active RRMS[1].

Key Takeaways

• Clinical Effectiveness: Alemtuzumab has shown a clinically important reduction in relapses for patients with highly active RRMS compared to interferon, but with limitations due to bias and small sample sizes.
• Market Growth: The MS therapies market, including alemtuzumab, is projected to grow at a CAGR of 3.7% from 2024 to 2032, reaching USD 37.8 billion.
• Technological Advancements: Innovations in DMTs and partnerships between pharmaceutical companies are driving market growth and expanding therapeutic options.
• Safety Concerns: Alemtuzumab is associated with significant safety risks, necessitating careful management and ongoing research to balance efficacy and safety.
• Future Directions: Ongoing trials and further research are essential for optimizing treatment strategies and informing economic evaluations.

FAQs

What is alemtuzumab used for?

Alemtuzumab is used in the treatment of multiple sclerosis (MS), particularly for adults with highly active relapsing-remitting MS, and is also being explored for use in certain types of leukemia.

What are the safety concerns associated with alemtuzumab?

Alemtuzumab is associated with risks of autoimmunity, infusion reactions, and malignancies, which has led to its availability only through a restricted program.

How is the market for alemtuzumab expected to grow?

The market for alemtuzumab, as part of the broader MS therapies market, is expected to grow at a CAGR of 3.7% from 2024 to 2032, reaching a projected value of USD 37.8 billion.

What regions are the largest markets for alemtuzumab?

North America, particularly the United States and Canada, represents the largest market for multiple sclerosis therapies, including alemtuzumab.

Are there ongoing clinical trials for alemtuzumab?

Yes, there are ongoing trials, such as the TREAT-MS and DELIVER-MS trials, which aim to compare early, high-efficacy treatment strategies versus traditional escalation strategies.

What is the current valuation of the alemtuzumab market?

The global alemtuzumab market was valued at approximately USD 2.5 billion in 2022.

Sources

1. Alemtuzumab, Cladribine, Fingolimod, Natalizumab, and Rituximab ... - National Center for Biotechnology Information
2. Multiple Sclerosis Therapies Market Size to Reach USD 37.8 Billion ... - BioSpace
3. Alemtuzumab-Market.md - GitHub
4. Cellectis starts alemtuzumab revival with FDA orphan drug win in ... - Pharmaceutical Technology
5. Global Multiple Sclerosis Therapies Report 2020-2025 - GlobeNewswire