CLINICAL TRIALS PROFILE FOR FLUDARABINE PHOSPHATE

All Clinical Trials for FLUDARABINE PHOSPHATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002779 ↗	Fludarabine Plus Octreotide in Treating Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1998-02-01	RATIONALE: Drugs used in chemotherapy and hormone therapy 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 fludarabine plus octreotide in treating patients who have relapsed low-grade non-Hodgkin's lymphoma.
NCT00002779 ↗	Fludarabine Plus Octreotide in Treating Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma	Completed	Alliance for Clinical Trials in Oncology	Phase 2	1998-02-01	RATIONALE: Drugs used in chemotherapy and hormone therapy 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 fludarabine plus octreotide in treating patients who have relapsed low-grade non-Hodgkin's lymphoma.
NCT00001586 ↗	Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): DNA Microarray Gene Expression Analysis	Completed	National Cancer Institute (NCI)	Phase 2	1997-09-01	Background: - Combined therapy with rituximab and fludarabine is the treatment of choice for advanced stage chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). - A new technology called deoxyribonucleic acid (DNA) microarray can be used to gain knowledge about the genetic basis of CLL/SLL. - Genetic studies of CLL/SLL may improve our understanding of what happens in the disease, help determine which patients are most likely to respond to treatment with fludarabine and rituximab, and identify new treatments. Objectives: -To gain further knowledge about CLL/SLL and the role of rituximab and fludarabine in treating the disease. Eligibility: -Patients 18 years of age and older with low, intermediate or high-risk CLL/SLL. Design: - Patients with low-risk CLL/SLL do not receive treatment, but are followed every 3 to 6 months and donate cells (through apheresis) or lymph nodes, or both, for research purposes. - Patients with intermediate or high-risk CLL/SLL receive standard treatment with rituximab and fludarabine for six 28-day treatment cycles. Rituximab is given on day 1 and fludarabine is given on days 1-5. (For the first cycle only, fludarabine treatment starts on day 2. This delay permits blood sampling on day 1 for the effect of rituximab on white blood cells.) - Laboratory tests and imaging studies are done periodically to monitor drug side effects and the response to treatment. Tests include bone marrow biopsy and aspiration, blood tests and x-rays, including positron emission tomography (PET) and computed tomography (CT) scans.
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
NCT00002833 ↗	Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	1994-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.
NCT00002833 ↗	Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia	Completed	M.D. Anderson Cancer Center	Phase 2	1994-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.

Clinical Trial Conditions for FLUDARABINE PHOSPHATE

Condition Name

Condition Name for FLUDARABINE PHOSPHATE
Intervention	Trials
Leukemia	171
Lymphoma	103
Myelodysplastic Syndromes	79
Myelodysplastic Syndrome	41

Condition MeSH

Condition MeSH for FLUDARABINE PHOSPHATE
Intervention	Trials
Leukemia	315
Myelodysplastic Syndromes	178
Preleukemia	172
Lymphoma	166

Clinical Trial Locations for FLUDARABINE PHOSPHATE

Trials by Country

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Trials by Country for FLUDARABINE PHOSPHATE
Location	Trials
Canada	54
United Kingdom	33
Italy	32
Australia	25
Japan	21

Trials by US State

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Trials by US State for FLUDARABINE PHOSPHATE
Location	Trials
Texas	126
Washington	105
California	81
New York	56
Maryland	53

Clinical Trial Progress for FLUDARABINE PHOSPHATE

Clinical Trial Phase

Clinical Trial Phase for FLUDARABINE PHOSPHATE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	26
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for FLUDARABINE PHOSPHATE
Clinical Trial Phase	Trials
Completed	249
Terminated	73
Recruiting	59

Clinical Trial Sponsors for FLUDARABINE PHOSPHATE

Sponsor Name

Sponsor Name for FLUDARABINE PHOSPHATE
Sponsor	Trials
National Cancer Institute (NCI)	291
M.D. Anderson Cancer Center	105
Fred Hutchinson Cancer Research Center	87

Sponsor Type

Sponsor Type for FLUDARABINE PHOSPHATE
Sponsor	Trials
Other	501
NIH	336
Industry	90

Fludarabine Phosphate: Clinical Trials, Market Analysis, and Projections

Introduction

Fludarabine phosphate is a chemotherapeutic agent used primarily in the treatment of various types of leukemia, particularly B-cell chronic lymphocytic leukemia (CLL). This article provides an update on the clinical trials, market analysis, and projections for fludarabine phosphate.

Clinical Trials Update

FDA Labeling Updates

The FDA has recently updated the labeling for fludarabine phosphate injection under the Project Renewal initiative, an effort by the Oncology Center of Excellence to update labeling for older oncology drugs. This update clarifies the dosage for combination therapy and streamlines safety warnings, providing clearer guidance for clinicians when using fludarabine phosphate in combination with cyclophosphamide and rituximab (Rituxan)[1].

Gedeptin and Fludarabine Phosphate Combination

GeoVax is conducting clinical trials involving the use of fludarabine phosphate as a prodrug in combination with Gedeptin, an investigational cancer therapy. The Phase 1b/2a trial evaluated the safety and efficacy of repeat cycles of Gedeptin therapy followed by fludarabine phosphate infusions in patients with advanced head and neck squamous cell carcinoma (HNSCC). The results showed acceptable safety and efficacy, supporting the advancement to a Phase 2 clinical trial. This upcoming trial aims to establish the efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in first-recurrence squamous cell head and neck cancer[4].

Market Analysis

Market Size and Growth

The fludarabine phosphate market has experienced significant growth in recent years and is projected to continue this trend. The global market size is expected to expand substantially from 2023 to 2031, driven by increasing demand for effective treatments for leukemia and other cancers. In North America, the market is anticipated to reach USD 1405.68 million in 2024, growing at a compound annual growth rate (CAGR) from 2025 to 2031[5].

Market Segmentation

The market is segmented by type (original drug and generic drug) and application (hospital pharmacies, retail pharmacies, and online pharmacies). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The generic drug segment is expected to contribute significantly to the market growth due to its cost-effectiveness and widespread adoption[2].

Key Players

The market includes both established and emerging players. Key companies such as Hisun Pharma, Pude Pharma, Jinrui Pharma, CISEN, LUMMY, Aosaikang Pharma, SANOFI, Actavis, Salius Pharma, Sagent Pharma, Bayer, Berlex Healthcare, and TEVA are profiled in market reports. These companies are driving innovation and competition in the fludarabine phosphate market[2].

Market Projections

Forecast Period

From 2024 to 2031, the fludarabine phosphate market is expected to exhibit robust growth. The positive market dynamics, combined with sustained expansion, indicate strong growth rates throughout the forecasted period. The market is positioned for significant development, driven by increasing demand for cancer treatments and the introduction of new combination therapies[2].

Drivers and Restraints

The market growth is driven by factors such as the increasing incidence of leukemia, advancements in cancer treatment protocols, and the approval of new combination therapies. However, restraints include the high cost of treatment, side effects associated with fludarabine phosphate, and regulatory challenges. A detailed analysis of market dynamics, including drivers, restraints, opportunities, and challenges, is crucial for understanding the market's future trajectory[2].

Regional Analysis

North America is expected to dominate the fludarabine phosphate market within the forecast period, driven by advanced healthcare infrastructure and high adoption rates of new cancer treatments. Europe and the Asia-Pacific region are also significant markets, with growing demand for fludarabine phosphate due to increasing cancer incidence and improving healthcare access[5].

Consumer Behavior and Market Trends

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the fludarabine phosphate market. While there were initial disruptions in supply chains and clinical trial enrollments, the pandemic also accelerated the adoption of telemedicine and online pharmacies, which has benefited the market in some aspects[5].

Technological Trends

Advancements in cancer treatment technologies, such as the use of prodrugs and combination therapies, are driving the market forward. For instance, the combination of Gedeptin with fludarabine phosphate represents a novel approach to treating solid tumors, which could significantly impact the market in the coming years[4].

Key Takeaways

• Updated Labeling: The FDA has updated the labeling for fludarabine phosphate to clarify dosage and safety warnings.
• Clinical Trials: Ongoing clinical trials, such as those involving Gedeptin and fludarabine phosphate, show promising results and potential for new treatment options.
• Market Growth: The global fludarabine phosphate market is projected to grow significantly from 2023 to 2031.
• Market Segmentation: The market is segmented by type, application, and geography, with the generic drug segment and North America expected to be key contributors.
• Drivers and Restraints: Increasing cancer incidence and advancements in treatment protocols drive the market, while high costs and side effects are significant restraints.

FAQs

What is the current status of fludarabine phosphate in clinical trials?

Fludarabine phosphate is being used in combination with Gedeptin in clinical trials for the treatment of head and neck squamous cell carcinoma, with plans to advance to a Phase 2 trial to establish efficacy in combination with an immune checkpoint inhibitor[4].

How has the FDA updated the labeling for fludarabine phosphate?

The FDA has updated the labeling to clarify the dosage for combination therapy and streamline safety warnings under the Project Renewal initiative[1].

What are the key drivers of the fludarabine phosphate market?

Key drivers include the increasing incidence of leukemia, advancements in cancer treatment protocols, and the approval of new combination therapies[2].

Which region is expected to dominate the fludarabine phosphate market?

North America is expected to dominate the market within the forecast period due to advanced healthcare infrastructure and high adoption rates of new cancer treatments[5].

What are the potential restraints to the fludarabine phosphate market?

High treatment costs, side effects associated with fludarabine phosphate, and regulatory challenges are significant restraints to the market[2].

Sources

1. FDA Updates Fludarabine Labeling Under Project Renewal Initiative. Targeted Oncology.
2. Global Fludarabine Phosphate Market Size, Trends and Projections. Market Research Intellect.
3. Gedeptin® Addition Expands GeoVax Immuno-Oncology Pipeline. Reportable News.
4. GeoVax Announces Phase 2 Plans for Gedeptin® Cancer Therapy. GeoVax.
5. North America Fludarabine Phosphate CAS 75607 67 9 Market Report. Cognitive Market Research.