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

Last Updated: April 18, 2025

CLINICAL TRIALS PROFILE FOR LEUCOVORIN CALCIUM


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Leucovorin Calcium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000643 ↗ Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To evaluate the effectiveness of pyrimethamine (given with leucovorin calcium versus placebo (an inactive substance) for the primary prophylaxis (prevention) of cerebral toxoplasmosis in HIV-infected patients. Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in the course of AIDS. The mortality (death) rate is estimated to be greater than 50 percent. Pyrimethamine is a drug that appears promising for the primary prevention of cerebral toxoplasmosis in HIV-infected patients.
NCT00000658 ↗ A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma Completed Schering-Plough Phase 3 1969-12-31 To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000658 ↗ A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000674 ↗ A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS Completed Glaxo Wellcome N/A 1969-12-31 To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Leucovorin Calcium

Condition Name

Condition Name for Leucovorin Calcium
Intervention Trials
Colorectal Cancer 140
Leukemia 45
Lymphoma 43
Metastatic Cancer 24
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Leucovorin Calcium
Intervention Trials
Colorectal Neoplasms 179
Adenocarcinoma 96
Leukemia 78
Precursor Cell Lymphoblastic Leukemia-Lymphoma 63
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Leucovorin Calcium

Trials by Country

Trials by Country for Leucovorin Calcium
Location Trials
Australia 90
United Kingdom 63
France 59
Puerto Rico 40
Portugal 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Leucovorin Calcium
Location Trials
New York 148
California 147
Illinois 128
Pennsylvania 123
Ohio 122
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Leucovorin Calcium

Clinical Trial Phase

Clinical Trial Phase for Leucovorin Calcium
Clinical Trial Phase Trials
Phase 4 3
Phase 3 127
Phase 2/Phase 3 9
[disabled in preview] 219
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Leucovorin Calcium
Clinical Trial Phase Trials
Completed 282
Unknown status 50
Terminated 44
[disabled in preview] 37
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Leucovorin Calcium

Sponsor Name

Sponsor Name for Leucovorin Calcium
Sponsor Trials
National Cancer Institute (NCI) 276
Children's Oncology Group 29
Alliance for Clinical Trials in Oncology 29
[disabled in preview] 20
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Leucovorin Calcium
Sponsor Trials
Other 516
NIH 296
Industry 64
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Leucovorin Calcium: Clinical Trials, Market Analysis, and Projections

Introduction to Leucovorin Calcium

Leucovorin calcium, also known as folinic acid, is a medication used in conjunction with certain chemotherapy drugs to enhance their efficacy and reduce side effects. It is particularly important in the treatment of various types of cancer, including colorectal, breast, lung, and ovarian cancer.

Clinical Trials Involving Leucovorin Calcium

Current Trials and Objectives

One notable clinical trial involving leucovorin calcium is the phase III trial conducted by the National Cancer Institute (NCI) to evaluate the effectiveness of oxaliplatin, leucovorin calcium, and fluorouracil with or without bevacizumab in treating patients who have undergone surgery for stage II colon cancer[1].

  • Primary Objectives: The trial aims to demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients.
  • Secondary Objectives: It also compares overall survival between the regimens, defines the toxicity profiles, and assesses the impact of tumor biological characteristics on patient survival.
  • Treatment Arms: Patients are randomized into different treatment arms, with some receiving oxaliplatin, leucovorin calcium, and fluorouracil, while others receive these drugs plus bevacizumab.

Another trial involves the use of liposomal irinotecan, fluorouracil, leucovorin calcium, and rucaparib in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other parts of the body. This phase I/II trial focuses on analyzing the side effects and best dose of these combined treatments[4].

Market Analysis of Leucovorin Calcium

Market Size and Growth

The global leucovorin calcium market is anticipated to experience significant growth over the coming years. As of 2024, the market size was valued at over 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[5].

Drivers of Market Growth

  • Rising Prevalence of Cancer: The increasing number of cancer cases globally is a major driver of the market. In 2020, around 19.3 million new cancer cases were recorded worldwide, which is expected to drive the demand for cancer treatments, including leucovorin calcium[2][5].
  • Geriatric Population: The rise in the geriatric population, who are at a higher risk of developing cancer, is also driving the demand for leucovorin calcium[3][5].
  • Combination Therapy: The effectiveness of combination therapy, which often includes leucovorin calcium, in treating cancer is another significant factor. Leucovorin calcium enhances the efficacy of certain chemotherapy drugs, particularly those used to treat colorectal cancer[3].

Market Segmentation

The global leucovorin calcium market is segmented by end users into hospitals, retail pharmacies, specialty clinics, and others. The hospital segment is anticipated to hold the largest market share due to the expansion of the healthcare system and the requirement for a prescription to obtain the drug[5].

Regional Market Analysis

  • North America: This region is expected to hold the largest market share due to the presence of major pharmaceutical companies and high healthcare expenditure in developed countries. The national healthcare expenditure in the U.S. grew by 9.7% to USD 4.1 trillion in 2020, supporting this growth[5].
  • Asia Pacific: The market in this region is also anticipated to grow significantly due to infrastructural improvements in the healthcare sector, an increase in R&D activity, and growing awareness about cancer treatment options[5].

Market Challenges and Opportunities

Challenges

  • High Cost and Availability of Alternatives: The high cost of leucovorin calcium and the availability of alternative treatments are major restraints for market growth[3].
  • Supply Issues: Restrictions on the import of raw materials into countries like the U.S., China, and India can lead to supply problems, affecting market growth[5].

Opportunities

  • Increasing R&D Activities: Companies are investing in research and development to create innovative and more effective therapies, which is expected to drive market growth[3].
  • Growing Awareness and Healthcare Infrastructure: Improving healthcare infrastructure and growing awareness about cancer and its treatment options are expected to present growth opportunities for the market[5].

Strategic Developments in the Leucovorin Calcium Market

The competitive landscape of the leucovorin calcium market is expected to intensify as new players enter the market and established companies expand their product portfolios. Companies are engaged in various activities such as manufacturing, marketing, and distributing leucovorin calcium products, as well as investing in mergers and acquisitions, partnerships, and collaborations to strengthen their market position[3].

Key Takeaways

  • The global leucovorin calcium market is expected to grow significantly due to the rising prevalence of cancer and the increasing geriatric population.
  • Clinical trials are ongoing to evaluate the effectiveness of leucovorin calcium in combination with other chemotherapy drugs.
  • The hospital segment is anticipated to hold the largest market share due to the expansion of the healthcare system.
  • North America and the Asia Pacific region are expected to be key markets driven by high healthcare expenditure and improving healthcare infrastructure.
  • Despite challenges such as high costs and supply issues, the market is expected to grow with increasing R&D activities and growing awareness about cancer treatment.

FAQs

Q1: What is leucovorin calcium used for?

Leucovorin calcium is used in conjunction with certain chemotherapy drugs to enhance their efficacy and reduce side effects, particularly in the treatment of various types of cancer.

Q2: What are the primary objectives of the phase III trial involving leucovorin calcium for stage II colon cancer?

The primary objectives include demonstrating an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients and comparing overall survival between different treatment regimens.

Q3: What are the major drivers of the leucovorin calcium market growth?

The major drivers include the rising prevalence of cancer, the increasing geriatric population, and the effectiveness of combination therapy.

Q4: Which region is expected to hold the largest market share for leucovorin calcium?

North America is expected to hold the largest market share due to the presence of major pharmaceutical companies and high healthcare expenditure in developed countries.

Q5: What are some of the challenges facing the leucovorin calcium market?

Challenges include the high cost of the drug, availability of alternatives, and supply issues due to restrictions on the import of raw materials.

Sources

  1. UCSF Colon Cancer Trial: Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer[1].
  2. Global Leucovorin Calcium Market Trends 2021: OMRGlobal[2].
  3. Leucovorin Calcium Market Forecast 2031: GrowthPlusReports[3].
  4. Clinical Trials - Mayo Foundation for Medical Education and Research: Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Cancer[4].
  5. Leucovorin Calcium Market Size, Growth Forecasts 2037: Research Nester[5].

More… ↓

⤷  Try for Free

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.