CLINICAL TRIALS PROFILE FOR WELLCOVORIN

All Clinical Trials for Wellcovorin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-06-01	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 patients with AIDS-related lymphoma.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 2	1993-06-01	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 patients with AIDS-related lymphoma.
NCT00002525 ↗	Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed	Terminated	American College of Surgeons	Phase 3	1993-08-01	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 and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer. PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.
NCT00002525 ↗	Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed	Terminated	Cancer and Leukemia Group B	Phase 3	1993-08-01	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 and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer. PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.
NCT00002525 ↗	Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed	Terminated	National Cancer Institute (NCI)	Phase 3	1993-08-01	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 and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer. PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.
NCT00002525 ↗	Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed	Terminated	NSABP Foundation Inc	Phase 3	1993-08-01	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 and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer. PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.
NCT00002525 ↗	Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed	Terminated	Southwest Oncology Group	Phase 3	1993-08-01	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 and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer. PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.

Clinical Trial Conditions for Wellcovorin

Condition Name

Condition Name for Wellcovorin
Intervention	Trials
Acute Lymphoblastic Leukemia	13
Leukemia	12
Untreated Adult Acute Lymphoblastic Leukemia	9
B Acute Lymphoblastic Leukemia	8

Condition MeSH

Condition MeSH for Wellcovorin
Intervention	Trials
Adenocarcinoma	32
Leukemia	30
Precursor Cell Lymphoblastic Leukemia-Lymphoma	30
Leukemia, Lymphoid	29

Clinical Trial Locations for Wellcovorin

Trials by Country

Trials by Country for Wellcovorin
Location	Trials
Canada	149
Australia	65
New Zealand	25
Puerto Rico	19
Switzerland	13

Trials by US State

Trials by US State for Wellcovorin
Location	Trials
Texas	51
California	44
Florida	38
New York	38
Michigan	38

Clinical Trial Progress for Wellcovorin

Clinical Trial Phase

Clinical Trial Phase for Wellcovorin
Clinical Trial Phase	Trials
Phase 3	26
Phase 2/Phase 3	2
Phase 2	39

Clinical Trial Status

Clinical Trial Status for Wellcovorin
Clinical Trial Phase	Trials
Completed	38
Recruiting	22
Active, not recruiting	17

Clinical Trial Sponsors for Wellcovorin

Sponsor Name

Sponsor Name for Wellcovorin
Sponsor	Trials
National Cancer Institute (NCI)	74
M.D. Anderson Cancer Center	17
Children's Oncology Group	17

Sponsor Type

Sponsor Type for Wellcovorin
Sponsor	Trials
Other	93
NIH	74
Industry	23

Wellcovorin: Clinical Trials, Market Analysis, and Projections

Introduction to Wellcovorin

Wellcovorin, also known as leucovorin calcium, is a medication used in conjunction with certain chemotherapy agents to prevent or reduce the severity of side effects, particularly those associated with high doses of methotrexate, trimethoprim, and pyrimethamine. It is also used to treat megaloblastic anemia and as part of chemotherapy regimens for various cancers.

Clinical Trials and Efficacy

Recent Clinical Trials

In the context of cancer treatment, leucovorin is often used in combination with other chemotherapy agents. For instance, the AtezoTRIBE study, a phase II randomized trial, investigated the efficacy of adding atezolizumab to a regimen of fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus bevacizumab in patients with metastatic colorectal cancer (mCRC). The study found that the addition of atezolizumab improved overall survival (OS) in the intention-to-treat population, with a median OS of 33.0 months compared to 27.2 months in the control group[1].

Biomarker Analysis

The AtezoTRIBE study also highlighted the importance of tumor immune-related biomarkers. Patients with high Immunoscore Immune-Checkpoint (IC) and high tumor mutational burden (TMB) derived greater benefit from the addition of atezolizumab, indicating that these biomarkers could be crucial in personalizing treatment strategies[1].

Safety and Efficacy in Other Cancers

Leucovorin is also used in other chemotherapy regimens. For example, a study on neoadjuvant chemotherapy for rectal cancer used a combination of liposomal irinotecan with 5-fluorouracil, leucovorin, and oxaliplatin, followed by chemoradiation, and found this regimen to be safe and effective[4].

Market Analysis

Market Size and Growth

The global leucovorin calcium market is experiencing significant growth driven by the increasing prevalence of cancer and other conditions requiring chemotherapy. In 2024, the market size was estimated at USD 26.98 million and is projected to exceed USD 187.87 million by 2037, with a compound annual growth rate (CAGR) of over 16.1% during the forecast period[2].

End-User Segmentation

The market is segmented by end-users into hospitals, retail pharmacies, and specialty clinics. Hospitals are expected to hold the largest market share due to the expanding healthcare system and the necessity of prescription-based access to leucovorin calcium. The growing cases of cancer and critical blood cell disorders further drive the demand in the hospital segment[2].

Regional Analysis

North America is anticipated to hold the largest revenue share by 2037, driven by the presence of major pharmaceutical companies and high healthcare expenditure in developed countries. The region's advanced healthcare infrastructure and rising number of patients with blood disorders and colorectal cancer also contribute to this growth[2].

Market Drivers

Increasing Cancer Cases

The global rise in cancer cases, with approximately 20 million cases recorded in 2020, is a significant driver for the leucovorin calcium market. Leucovorin is widely used in chemotherapy processes, making it an essential drug in cancer treatment[2].

Blood Cell Disorders

The increasing incidence of blood cell disorders such as anemia, thrombocytopenia, and neutropenia, caused by high doses of certain antagonists, is another key factor driving market growth. Leucovorin calcium is used to mitigate these side effects, thereby increasing its demand[2].

Megaloblastic Anemia

Leucovorin calcium is also used to treat megaloblastic anemia, particularly when oral therapy is not feasible. With about 1 in 7,500 people in the United States developing megaloblastic anemia each year, this condition contributes to the market's growth[2].

Market Challenges

Accessibility and Prescription Requirements

The need for a prescription and the limited accessibility of leucovorin calcium can act as barriers to market growth. However, the expansion of the healthcare system and the increasing availability of the drug in hospitals and specialty clinics are mitigating these challenges[2].

Cost and Healthcare Expenditure

High healthcare expenditure is necessary to support the use of leucovorin calcium, particularly in developed countries. However, the cost-effectiveness of the drug in treating various conditions makes it a valuable investment in healthcare[2].

Projections and Future Outlook

Market Forecast

By 2037, the leucovorin calcium market is expected to exceed USD 187.87 million, driven by the growing demand for chemotherapy and the treatment of related side effects. The market's CAGR of over 16.1% during the forecast period indicates a robust growth trajectory[2].

Technological and Therapeutic Advancements

Advancements in chemotherapy regimens and the development of new biomarkers will continue to influence the use and efficacy of leucovorin calcium. For instance, the integration of leucovorin with other drugs like atezolizumab and the use of nanotechnology to enhance drug delivery are promising areas of research[1][4].

Key Takeaways

• Clinical Efficacy: Leucovorin calcium has shown efficacy in combination with other chemotherapy agents, particularly in treating metastatic colorectal cancer.
• Market Growth: The global leucovorin calcium market is projected to grow significantly, driven by increasing cancer cases and the need for chemotherapy.
• End-User Demand: Hospitals are expected to be the largest end-users due to the prescription-based nature of the drug and the expanding healthcare system.
• Regional Dominance: North America is anticipated to hold the largest market share due to high healthcare expenditure and advanced healthcare infrastructure.
• Future Outlook: The market is expected to exceed USD 187.87 million by 2037, with technological and therapeutic advancements continuing to drive growth.

FAQs

What is Wellcovorin (leucovorin calcium) used for?

Wellcovorin, or leucovorin calcium, is used to prevent or reduce the severity of side effects associated with certain chemotherapy agents, treat megaloblastic anemia, and as part of chemotherapy regimens for various cancers.

What are the key drivers of the leucovorin calcium market?

The key drivers include the increasing prevalence of cancer, rising cases of blood cell disorders, and the treatment of megaloblastic anemia.

Which region is expected to dominate the leucovorin calcium market?

North America is anticipated to hold the largest revenue share due to the presence of major pharmaceutical companies, high healthcare expenditure, and advanced healthcare infrastructure.

What is the projected market size of leucovorin calcium by 2037?

The global leucovorin calcium market is expected to exceed USD 187.87 million by 2037, with a CAGR of over 16.1% during the forecast period.

How does leucovorin calcium benefit patients with metastatic colorectal cancer?

Leucovorin calcium, when used in combination with other chemotherapy agents like FOLFOXIRI and atezolizumab, has been shown to improve overall survival in patients with metastatic colorectal cancer, particularly those with high Immunoscore Immune-Checkpoint and high tumor mutational burden.

What are the challenges facing the leucovorin calcium market?

The challenges include the need for prescription-based access, limited accessibility, and high healthcare expenditure required to support its use.

Sources

1. Upfront Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan Plus ... - PubMed.
2. Leucovorin Calcium Market Size, Growth Forecasts 2037 - Research Nester.
3. Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032] - Fortune Business Insights.
4. Wellcovorin journal articles from PubMed - Unbound Medicine.
5. Leucovorin Calcium Market Report 2024 (Global Edition) - Cognitive Market Research.