You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR MYLERAN


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Myleran

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002831 ↗ Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia Completed National Cancer Institute (NCI) Phase 1/Phase 2 1995-08-01 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. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
NCT00002831 ↗ Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia Completed M.D. Anderson Cancer Center Phase 1/Phase 2 1995-08-01 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. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
NCT00002961 ↗ Chemotherapy With or Without Total-Body Irradiation Prior to Bone Marrow Transplantation in Treating Children With Acute Lymphoblastic Leukemia Terminated Children's Hospital of Philadelphia Phase 3 1995-10-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy, radiation therapy, and bone marrow transplantation may kill more cancer cells. PURPOSE: Randomized phase III trial to compare high-dose chemotherapy with or without total-body irradiation before bone marrow transplantation in treating children with acute lymphoblastic leukemia.
NCT00004088 ↗ Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma Completed National Cancer Institute (NCI) Phase 2 1999-04-13 RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies, such as interferon alfa, use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma. PURPOSE: This phase II trial is studying combination chemotherapy, peripheral stem cell transplantation, biological therapy, pamidronate, and thalidomide to see how well they work in treating patients with stage I, stage II, or stage III multiple myeloma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Myleran

Condition Name

Condition Name for Myleran
Intervention Trials
Leukemia 26
Lymphoma 19
Acute Myeloid Leukemia 19
Myelodysplastic Syndrome 17
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Myleran
Intervention Trials
Leukemia 51
Leukemia, Myeloid 32
Leukemia, Myeloid, Acute 29
Myelodysplastic Syndromes 27
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Myleran

Trials by Country

Trials by Country for Myleran
Location Trials
United States 230
Canada 9
Mexico 3
Denmark 2
Israel 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Myleran
Location Trials
Texas 49
Florida 9
New York 9
Ohio 9
Illinois 9
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Myleran

Clinical Trial Phase

Clinical Trial Phase for Myleran
Clinical Trial Phase Trials
Phase 3 9
Phase 2 50
Phase 1/Phase 2 14
[disabled in preview] 13
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Myleran
Clinical Trial Phase Trials
Completed 31
Recruiting 21
Terminated 18
[disabled in preview] 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Myleran

Sponsor Name

Sponsor Name for Myleran
Sponsor Trials
M.D. Anderson Cancer Center 46
National Cancer Institute (NCI) 37
Fred Hutchinson Cancer Research Center 6
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Myleran
Sponsor Trials
Other 107
NIH 42
Industry 16
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Myleran (Busulfan): Clinical Trials, Market Analysis, and Projections

Introduction to Myleran (Busulfan)

Myleran, known generically as busulfan, is a potent chemotherapeutic agent used primarily for the palliative treatment of chronic myelogenous leukemia (CML). Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Use and Efficacy

Myleran is indicated for the palliative treatment of CML, particularly in patients with the Philadelphia chromosome (Ph1)[1].

  • It reduces the total granulocyte mass, relieves symptoms, and improves the clinical state of patients.
  • Approximately 90% of adults with previously untreated CML achieve hematologic remission with busulfan.
  • However, it is less effective in patients lacking the Ph1 chromosome and in those with the "blastic" phase of CML.

Current Clinical Trials

While Myleran itself is not the focus of new clinical trials, its use in preparative regimens for bone marrow transplants is significant.

BEACON Trial

One notable trial is the BEACON trial, which involves base editing of hematopoietic stem cells (HSCs) to correct faulty genes. This trial uses busulfan to create space in the bone marrow before the transplant. Although the trial has faced challenges, including a reported death attributed to busulfan side effects, it holds promise for treating inherited blood diseases[4].

Market Analysis

Global Market Size and Growth

The global busulfan market is analyzed in terms of market size, trends, and demand forecasts. Here are some key points:

  • Market Size: The global busulfan market is segmented by type (injection and tablet), application, company, and region. The market size and growth rate are projected up to 2030, with detailed breakdowns by region and application[2].
  • Growth Factors: The market is driven by the increasing incidence of CML and other hematological malignancies, as well as advancements in treatment protocols.
  • Regional Analysis: The market is analyzed across various regions, including North America, Asia, and the Middle East, Africa, and Latin America. Each region's market size, growth rate, and key players are detailed[2].

Key Players

The busulfan market includes several key players:

  • Otsuka: Known for its busulfan products, Otsuka is a significant player in the market.
  • Aspen Pharmacare: Another major company involved in the production and distribution of busulfan[2].

Market Projections

Future Growth

The global busulfan market is expected to grow steadily over the next few years, driven by several factors:

  • Increasing Incidence of CML: The rising number of CML cases globally will increase the demand for effective treatments like busulfan.
  • Advancements in Treatment: Continued research and development in hematological malignancies will likely enhance the market for busulfan.
  • Regional Expansion: The market is expected to expand in regions with growing healthcare expenditures and increasing awareness of CML treatments[2].

Challenges and Opportunities

Despite the growth potential, there are challenges to consider:

  • Lack of Generic Versions: Currently, there is no therapeutically equivalent generic version of Myleran available in the United States, which could impact market dynamics[5].
  • Side Effects and Safety Concerns: The use of busulfan is associated with significant side effects, including those observed in clinical trials like the BEACON trial. Managing these risks will be crucial for market growth.

Conclusion

Myleran (busulfan) remains a critical drug in the treatment of CML, with a well-established clinical efficacy profile. While it is not the focus of new clinical trials, its role in preparative regimens for bone marrow transplants continues to be important. The global market for busulfan is projected to grow, driven by increasing incidence rates of CML and advancements in treatment protocols. However, the lack of generic versions and safety concerns must be addressed to fully realize the market potential.

Key Takeaways

  • Myleran (busulfan) is used for the palliative treatment of CML, particularly in patients with the Ph1 chromosome.
  • The drug is effective in achieving hematologic remission but has limitations in certain patient groups.
  • The BEACON trial highlights the ongoing use of busulfan in bone marrow transplant preparations.
  • The global busulfan market is expected to grow due to increasing CML incidence and advancements in treatments.
  • Lack of generic versions and safety concerns are significant market challenges.

FAQs

What is Myleran (busulfan) used for?

Myleran (busulfan) is used for the palliative treatment of chronic myelogenous leukemia (CML), particularly in patients with the Philadelphia chromosome (Ph1)[1].

Is Myleran effective in all types of CML?

No, Myleran is less effective in patients lacking the Ph1 chromosome and in those with the "blastic" phase of CML[1].

Are there any ongoing clinical trials involving Myleran?

While Myleran itself is not the focus of new trials, it is used in preparative regimens for trials like the BEACON trial, which involves base editing of hematopoietic stem cells[4].

What are the key drivers of the global busulfan market?

The key drivers include the increasing incidence of CML, advancements in treatment protocols, and regional expansion in healthcare expenditures[2].

Is there a generic version of Myleran available?

No, there is currently no therapeutically equivalent generic version of Myleran available in the United States[5].

What are the significant challenges facing the busulfan market?

The lack of generic versions and safety concerns, including significant side effects, are significant challenges for the market[2][5].

More… ↓

⤷  Free Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.