CLINICAL TRIALS PROFILE FOR CERUBIDINE

All Clinical Trials for Cerubidine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002590 ↗	Combination Chemotherapy in Treating Children With Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1994-07-01	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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.
NCT00002590 ↗	Combination Chemotherapy in Treating Children With Lymphoma	Completed	Children's Oncology Group	Phase 2	1994-07-01	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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.
NCT00002798 ↗	Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 3	1996-08-01	Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. 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. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome
NCT00003190 ↗	Combination Chemotherapy With or Without Valspodar in Treating Patients With Previously Untreated Acute Myeloid Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	1998-01-01	Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without PSC 833 followed by interleukin-2 or no further therapy in treating older patients who have acute myeloid leukemia. Some cancers become resistant to chemotherapy drugs. Combining PSC 833 with more than one chemotherapy drug may reduce resistance to the drugs and allow the cancer cells to be killed. Combining interleukin-2 with combination chemotherapy plus PSC 833 may kill more cancer cells.
NCT00003593 ↗	Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 3	1999-06-01	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. PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia, or myelodysplastic syndrome.
NCT00003593 ↗	Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome	Completed	Children's Oncology Group	Phase 3	1999-06-01	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. PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder, acute myelogenous leukemia, or myelodysplastic syndrome.
NCT00003671 ↗	Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphocytic Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	1998-12-01	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 children who have newly diagnosed acute lymphocytic leukemia.

Clinical Trial Conditions for Cerubidine

Condition Name

Condition Name for Cerubidine
Intervention	Trials
Acute Myeloid Leukemia	21
Untreated Adult Acute Myeloid Leukemia	19
Leukemia	12
Acute Lymphoblastic Leukemia	10

Condition MeSH

Condition MeSH for Cerubidine
Intervention	Trials
Leukemia	66
Leukemia, Myeloid, Acute	38
Leukemia, Myeloid	35
Precursor Cell Lymphoblastic Leukemia-Lymphoma	30

Clinical Trial Locations for Cerubidine

Trials by Country

Trials by Country for Cerubidine
Location	Trials
Canada	155
Australia	64
New Zealand	23
Puerto Rico	16
Switzerland	12

Trials by US State

Trials by US State for Cerubidine
Location	Trials
Illinois	42
North Carolina	41
California	38
New York	37
Florida	36

Clinical Trial Progress for Cerubidine

Clinical Trial Phase

Clinical Trial Phase for Cerubidine
Clinical Trial Phase	Trials
Phase 3	27
Phase 2/Phase 3	2
Phase 2	24

Clinical Trial Status

Clinical Trial Status for Cerubidine
Clinical Trial Phase	Trials
Completed	34
Active, not recruiting	18
Recruiting	7

Clinical Trial Sponsors for Cerubidine

Sponsor Name

Sponsor Name for Cerubidine
Sponsor	Trials
National Cancer Institute (NCI)	56
Children's Oncology Group	20
Wake Forest University Health Sciences	3

Sponsor Type

Sponsor Type for Cerubidine
Sponsor	Trials
NIH	56
Other	48
Industry	13

Clinical Trials, Market Analysis, and Projections for Cerubidine

Introduction

Cerubidine, also known as daunorubicin, is a chemotherapeutic agent used primarily in the treatment of various types of leukemia, including acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Here, we will delve into the current state of clinical trials, market analysis, and future projections for Cerubidine.

Clinical Trials and Efficacy

Historical Context

Cerubidine has been a staple in chemotherapy regimens for decades. It is often used in combination with other drugs to enhance its efficacy. For instance, in the treatment of AML, Cerubidine is commonly combined with cytarabine and other agents as part of intensive chemotherapy protocols[2].

Current Trials and Updates

While Cerubidine itself is not typically the subject of new clinical trials due to its established use, it is often included in combination therapies in ongoing studies. For example, trials focusing on new combinations or adjunct therapies may still utilize Cerubidine as a core component. The AtezoTRIBE study, although not specifically focused on Cerubidine, highlights the evolving landscape of combination therapies in cancer treatment, which can influence the use of established drugs like Cerubidine[4].

Market Analysis

Global Market for Acute Myeloid Leukemia

The global AML market, which includes Cerubidine, is projected to grow significantly. The market is expected to expand at a CAGR of around 13% from 2022 to 2027, driven by the increasing use of chemotherapy agents like cytarabine and other targeted therapies[2].

Market Share and Competition

Cerubidine, being an older drug, faces competition from newer, more targeted therapies such as midostaurin (Rydapt), gilteritinib (Xospata), and ivosidenib (Tibsovo). However, its established efficacy and cost-effectiveness ensure it remains a viable option in many treatment protocols. The market share of Cerubidine is influenced by its inclusion in standard chemotherapy regimens and its availability in various regions[2].

Market Projections

Growth Drivers

The growth of the AML market, and by extension the demand for Cerubidine, is driven by several factors:

• Increasing Incidence of AML: The rising number of AML cases globally contributes to the growing demand for effective treatments.
• Advancements in Combination Therapies: New clinical trials and approvals of combination therapies that include Cerubidine or similar agents are expected to boost its market presence.
• Cost-Effectiveness: Compared to newer targeted therapies, Cerubidine remains a cost-effective option, making it accessible in a broader range of healthcare settings[2].

Regional Analysis

The market for AML treatments, including Cerubidine, varies by region. North America and Europe are significant markets due to their advanced healthcare systems and higher incidence of AML. However, the Asia-Pacific region is expected to show substantial growth due to increasing healthcare spending and a larger patient population[2].

Safety and Side Effects

Clinical Safety Profile

Cerubidine is known for its cardiotoxic side effects, which can be a significant concern, especially at higher doses or with prolonged use. However, its safety profile is well understood, and it remains a valuable tool in oncology when used judiciously. The safety data from ongoing and past trials continue to inform its use and dosing strategies[2].

Future Outlook

Emerging Trends

The future of Cerubidine in the market will be influenced by emerging trends in cancer treatment:

• Targeted Therapies: The development of targeted therapies may reduce the reliance on traditional chemotherapeutic agents like Cerubidine. However, these new therapies often complement rather than replace existing treatments.
• Combination Therapies: The trend towards combination therapies is likely to continue, with Cerubidine being used in conjunction with newer agents to enhance treatment outcomes[2][5].

Key Takeaways

• Established Efficacy: Cerubidine remains an effective treatment for various types of leukemia.
• Market Growth: The AML market, which includes Cerubidine, is expected to grow at a CAGR of around 13% from 2022 to 2027.
• Competition and Trends: The market is evolving with the introduction of newer targeted therapies, but Cerubidine's cost-effectiveness and established use ensure its continued relevance.
• Safety Considerations: The drug's safety profile, including cardiotoxicity, must be carefully managed.

FAQs

1. What is Cerubidine used for? Cerubidine, or daunorubicin, is primarily used in the treatment of acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).

2. How does Cerubidine fit into current chemotherapy regimens? Cerubidine is often used in combination with other chemotherapeutic agents such as cytarabine as part of intensive chemotherapy protocols.

3. What are the major side effects of Cerubidine? The major side effects include cardiotoxicity, which can be a significant concern, especially at higher doses or with prolonged use.

4. How is the market for Cerubidine expected to grow? The market for AML treatments, including Cerubidine, is expected to grow at a CAGR of around 13% from 2022 to 2027, driven by increasing incidence and advancements in combination therapies.

5. What are the emerging trends that could impact the use of Cerubidine? Emerging trends include the development of targeted therapies and the continued use of combination therapies, which may influence the role of Cerubidine in future treatment protocols.

Sources

1. Arvinas and Pfizer Announce Updated Clinical Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®) - Pfizer.
2. Acute Myeloid Leukemia Market Insights | CAGR 13% by 2027 - MarkNtel Advisors.
3. Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032] - Fortune Business Insights.
4. Upfront Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan Plus ... - PubMed.
5. 2025 Anticipated Drug Approvals: Key New Treatments to Watch - Vegan Med.