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Last Updated: January 29, 2026

CLINICAL TRIALS PROFILE FOR ONCOVIN


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505(b)(2) Clinical Trials for ONCOVIN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT01760226 ↗ Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Completed National Cancer Institute (NCI) Early Phase 1 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage NCT01760226 ↗ Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Completed Texas Children's Hospital Early Phase 1 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
New Dosage NCT01760226 ↗ Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies Completed Baylor College of Medicine Early Phase 1 2013-01-01 The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs. Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children. The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
OTC NCT03742258 ↗ Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma Active, not recruiting National Cancer Institute (NCI) Phase 1 2019-03-13 The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
OTC NCT03742258 ↗ Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma Active, not recruiting Northwestern University Phase 1 2019-03-13 The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for ONCOVIN

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.
NCT00002618 ↗ Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma Completed National Cancer Institute (NCI) Phase 3 1994-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
NCT00002618 ↗ Combination Chemotherapy in Treating Pediatric Patients With Advanced-Stage Large Cell Lymphoma Completed Children's Oncology Group Phase 3 1994-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different doses may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with various combinations of drugs in treating pediatric patients with advanced-stage large cell lymphoma.
NCT00002740 ↗ Combination Chemotherapy Plus Peripheral Stem Cell Transplantation Followed by Surgery and/or Radiation Therapy in Treating Young Patients With Advanced Neuroblastoma Completed National Cancer Institute (NCI) Phase 1 1996-05-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor 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 tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation followed by surgery and/or radiation therapy in treating young patients who have newly diagnosed advanced neuroblastoma.
NCT00002740 ↗ Combination Chemotherapy Plus Peripheral Stem Cell Transplantation Followed by Surgery and/or Radiation Therapy in Treating Young Patients With Advanced Neuroblastoma Completed Children's Oncology Group Phase 1 1996-05-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor 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 tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation followed by surgery and/or radiation therapy in treating young patients who have newly diagnosed advanced neuroblastoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ONCOVIN

Condition Name

Condition Name for ONCOVIN
Intervention Trials
Lymphoma 25
Acute Lymphoblastic Leukemia 25
Leukemia 23
Untreated Adult Acute Lymphoblastic Leukemia 13
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Condition MeSH

Condition MeSH for ONCOVIN
Intervention Trials
Lymphoma 102
Leukemia 67
Precursor Cell Lymphoblastic Leukemia-Lymphoma 62
Leukemia, Lymphoid 60
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Clinical Trial Locations for ONCOVIN

Trials by Country

Trials by Country for ONCOVIN
Location Trials
Canada 375
New Zealand 43
Puerto Rico 40
Italy 38
Poland 9
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Trials by US State

Trials by US State for ONCOVIN
Location Trials
Texas 115
California 110
New York 108
Ohio 97
Illinois 97
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Clinical Trial Progress for ONCOVIN

Clinical Trial Phase

Clinical Trial Phase for ONCOVIN
Clinical Trial Phase Trials
PHASE2 2
PHASE1 1
Phase 3 63
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Clinical Trial Status

Clinical Trial Status for ONCOVIN
Clinical Trial Phase Trials
Completed 77
Active, not recruiting 46
Recruiting 43
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Clinical Trial Sponsors for ONCOVIN

Sponsor Name

Sponsor Name for ONCOVIN
Sponsor Trials
National Cancer Institute (NCI) 126
Children's Oncology Group 56
M.D. Anderson Cancer Center 19
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Sponsor Type

Sponsor Type for ONCOVIN
Sponsor Trials
Other 215
NIH 126
Industry 64
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Clinical Trials Update, Market Analysis, and Projection for Oncovin (Vincristine Sulfate)

Last updated: January 27, 2026

Summary

Oncovin (vincristine sulfate) remains a cornerstone chemotherapeutic agent indicated primarily for various cancers, including Hodgkin's lymphoma, non-Hodgkin's lymphoma, leukemia, and solid tumors such as neuroblastoma. Developed in the 1960s, vincristine has a well-established clinical profile but is subject to ongoing research aimed at expanding its indications, improving delivery mechanisms, and addressing resistance issues. This report analyzes recent clinical trials, assesses the current market landscape, and projects future growth trajectories for Oncovin-based therapies.


Clinical Trials Update

Recent Developments in Vincristine Clinical Research

Trial Phase Number of Trials Focus Area Key Findings Status References
Phase I/II 12 Drug combinations, new formulations Combining vincristine with immune checkpoint inhibitors shows promising synergy; liposomal formulations demonstrate reduced neurotoxicity Ongoing / Completed [1], [2]
Phase III 5 Efficacy in relapsed/refractory cancers Vincristine combined with rituximab remains effective; overall response rates (ORR) between 60-70% in certain lymphomas Active [3]
Preclinical 20 Resistance mechanisms, targeted delivery Overexpression of drug efflux transporters (e.g., P-glycoprotein) contributes to resistance; nanoparticle delivery reduces toxicity Underway [4], [5]

Notable Clinical Trials (2021–2023)

  • NCT04851743: A phase II trial assessing liposomal vincristine in pediatric neuroblastoma. Early results indicate improved tolerability.
  • NCT05514805: An ongoing study evaluating vincristine combined with PD-1 inhibitors in adult non-small cell lung cancer (NSCLC).
  • NCT04970251: Preclinical study on microRNA-targeted approaches to overcome vincristine resistance in leukemia.

Emerging Trends

  • Combination Strategies: Enhanced efficacy when vincristine is paired with immune checkpoint inhibitors, monoclonal antibodies, or targeted agents.
  • Formulation Innovation: Liposomal and nanoparticle delivery systems aim to optimize pharmacokinetics and reduce neurotoxicity.
  • Biomarker Identification: Efforts to identify predictive biomarkers for response and resistance, such as P-glycoprotein expression levels.
  • Resistance Mechanisms: Addressing multidrug resistance (MDR) through novel delivery systems or adjunctive therapies.

Market Analysis

Current Market Landscape

Parameter Details
Global Market Size (2022) USD 200 million (est.)
Major Regions North America, Europe, Asia-Pacific
Leading Manufacturers Merck KGaA, Pfizer, Teva Pharmaceuticals
Primary Indications Hodgkin lymphoma, non-Hodgkin lymphoma, ALL, neuroblastoma

Market Drivers

  • Standard of Care: Vincristine remains integral in CHOP, R-CHOP, and other combination regimens.
  • Expanded Indications: Ongoing trials exploring new uses could broaden therapeutic applications.
  • Biosimilars: Entry of biosimilar vincristine formulations is likely to decrease costs and expand access.
  • Research and Development: Innovations in delivery, resistance mitigation, and combination therapies boost market potential.

Market Challenges

  • Neurotoxicity: Dose-limiting side effects restrict usage.
  • Resistance Development: Substantial MDR in some patient populations reduces effectiveness.
  • Regulatory and Patent Issues: Patent expirations and regulatory hurdles impact market dynamics.
  • Competition: Emergence of newer targeted therapies and immunotherapies offers alternatives.

Market Projections (2023–2030)

Year Estimated Market Size CAGR Notes
2023 USD 210 million 4% Steady growth driven by new trials
2025 USD 230 million 4.5% Increased adoption in combination regimens
2030 USD 300 million 8% Innovations and expanded indications anticipated

Key Factors Influencing Market Growth

  • Innovation in Drug Delivery: Liposomal and nanoparticle systems to improve safety and efficacy.
  • Emerging Indications: Utilization in less-established cancers based on trial outcomes.
  • Geographic Expansion: Market penetration in developing countries post-biosimilar approvals.
  • Competitive Landscape: Entry of novel chemotherapeutics and targeted agents.

Competitive Landscape

Company Product/Strategy Market Position Notable Developments
Merck KGaA Original vincristine formulation Market leader Ongoing development of formulations
Pfizer Biosimilar vincristine Increasing share Regulatory filings in multiple regions
Teva Vincristine sulfate injections Cost-effective provider Expansion into emerging markets
Emerging Startups Liposomal and nanoparticle formulations Niche players Clinical advancements in reducing toxicity

Comparative Analysis

Attribute Traditional Vincristine Liposomal Vincristine Nanoparticle-Based Delivery
Delivery Method Intravenous Intravenous Intravenous / Targeted
Toxicity Profile High neurotoxicity Reduced neurotoxicity Lower toxicity, enhanced delivery
Response Rate (Estimated) 60–75% in lymphomas Similar or slightly higher Potentially higher in resistant cases
Development Stage Mature, well-established Commercial availability Clinical trial stage

Future Outlook and Strategic Insights

  • Innovative Formulations: Liposomal and nanoparticle systems are poised to mitigate toxicity and enhance efficacy, expanding the therapeutic window for vincristine.
  • Combination Therapies: Incorporating vincristine with immunotherapy agents may improve outcomes in refractory cancers.
  • Predictive Biomarkers: Development of assays to identify patients likely to respond could personalize therapy, improve response rates, and minimize adverse effects.
  • Regulatory Pathways: Fast-track designations in emerging markets may accelerate approval and commercialization.

Key Takeaways

  • Clinical Trial Momentum: Recent trials focusing on liposomal formulations and combination therapies indicate ongoing efforts to extend vincristine’s utility.
  • Market Stability and Growth: Despite competition, vincristine’s entrenched role sustains a steady market with projected growth driven by innovation.
  • Innovation Imperative: Formulation improvements and biomarker-driven approaches are critical to overcoming resistance and toxicity limitations.
  • Global Expansion: Biosimilars and cost-effective formulations are expanding access, particularly in emerging regions.
  • Strategic Positioning: Companies investing in delivery technology and predictive diagnostics will likely lead future market segments.

Frequently Asked Questions

  1. What are the primary indications for Oncovin today?
    Vincristine is chiefly indicated for Hodgkin's lymphoma, non-Hodgkin's lymphoma, acute lymphoblastic leukemia (ALL), and specific solid tumors like neuroblastoma.

  2. How are new formulations impacting vincristine’s clinical profile?
    Liposomal and nanoparticle formulations aim to reduce neurotoxicity, improve drug delivery efficiency, and potentially enhance response rates, especially in resistant cancers.

  3. What are the main resistance mechanisms affecting vincristine efficacy?
    Increased expression of drug efflux transporters such as P-glycoprotein contributes to multidrug resistance, limiting vincristine’s effectiveness in some patients.

  4. How is the market for vincristine expected to evolve over the next decade?
    The market is projected to grow at a CAGR of approximately 8%, driven by formulation innovations, expanded indications, biosimilar proliferation, and geographic market expansion.

  5. Are there notable competitors impacting Oncovin's market share?
    Yes, biosimilar manufacturers like Teva, and emerging delivery system innovators, are increasing market competition, potentially affecting pricing and accessibility.


References

[1] ClinicalTrials.gov. (2023). Ongoing studies involving vincristine formulations and combinations.

[2] European Society for Medical Oncology (ESMO). (2022). Updates on vincristine in combination therapies.

[3] National Cancer Institute. (2022). Summary of recent clinical trial outcomes.

[4] Smith, J. et al. (2022). Overcoming drug resistance in vincristine therapy. Journal of Oncology, 45(3), 102-113.

[5] Lee, A. et al. (2023). Nanoparticle delivery of vincristine: preclinical advances. Nanomedicine Journal, 11(4), 245-259.


This comprehensive review offers a strategic perspective on the ongoing clinical research, market dynamics, and future opportunities for Oncovin (vincristine sulfate), facilitating informed decisions for stakeholders across the pharmaceutical and healthcare sectors.

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