CLINICAL TRIALS PROFILE FOR FLUDARA

All Clinical Trials for FLUDARA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001832 ↗	Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma	Completed	National Cancer Institute (NCI)	Phase 2	1999-08-01	This experiment will test the safety and effectiveness of a treatment for melanoma in which certain lymphocytes (a type of white blood cell) are taken from the patient, grown in the laboratory, and returned after the patient's immune system has been weakened with immune-suppressing drugs. Some patients will also receive interleukin-2 (IL-2), a drug that may enhance the activity of the re-infused lymphocytes. Patients with metastatic melanoma (melanoma whose tumor has spread) who have been treated unsuccessfully with gp100 vaccination may participate in this study. They will undergo apheresis or a tumor biopsy, or both, to collect lymphocytes. In apheresis, whole blood is drawn through a needle in the arm. A machine separates the blood components and removes the white cells. The rest of the blood is returned to the donor through a needle in the other arm. A biopsy is a surgical procedure to remove a small piece of tumor tissue. Several weeks before the lymphocytes are collected, patients will receive injections of growth colony stimulating factor (G-CSF) every day for five days. This drug stimulates white cell production, permitting as many cells as possible to be obtained during collection. The lymphocytes will then be grown in larger numbers in the laboratory. Seven days before the cells are re-infused, the patient is admitted to the hospital and a catheter (small tube) is placed in a large vein in the chest or neck. Two drugs, cyclophosphamide and fludarabine, are given through the tube. These drugs suppress the immune system so that it will not interfere with the work of the reinfused lymphocytes. The lymphocytes are then injected through the catheter over a 30-minute period. After the infusion, patients who receive IL-2 will be given the drug in a high dose over a 15-minute period every eight hours for up to five days. Patients whose condition does not permit high-dose IL-2, such as those with a heart condition or lung problem, may receive a low-dose regimen, with the drug given as a shot under the skin of the thigh or abdomen for five days followed by a 2-day break, continuing for a total of six weeks. These patients receive a higher dose the first week and then half that dose the next five weeks. Blood and tissue samples will be taken before and during the study to evaluate the size of the tumor and assess treatment. If, 3-5 weeks after therapy is completed, the patient's tumor has stabilized or shrunk, the entire treatment, except for chemotherapy, may be repeated two more times.
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.
NCT00002838 ↗	Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	1995-12-01	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 and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic leukemia.
NCT00002838 ↗	Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia	Completed	M.D. Anderson Cancer Center	Phase 1/Phase 2	1995-12-01	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 and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic leukemia.
NCT00003204 ↗	Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	1998-03-01	Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy followed by rituximab or observation in treating patients who have stage III or stage IV low-grade non-Hodgkin's lymphoma. 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. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which regimen of combination chemotherapy, with or without rituximab, is more effective for non-Hodgkin's lymphoma

Clinical Trial Conditions for FLUDARA

Condition Name

Condition Name for FLUDARA
Intervention	Trials
Leukemia	87
Myelodysplastic Syndrome	52
Lymphoma	50
Acute Myeloid Leukemia	48

Condition MeSH

Condition MeSH for FLUDARA
Intervention	Trials
Leukemia	248
Leukemia, Myeloid	150
Leukemia, Myeloid, Acute	146
Myelodysplastic Syndromes	142

Clinical Trial Locations for FLUDARA

Trials by Country

Trials by Country for FLUDARA
Location	Trials
Canada	29
Japan	22
Italy	16
Germany	13
Australia	12

Trials by US State

Trials by US State for FLUDARA
Location	Trials
Texas	133
Washington	85
Maryland	64
Minnesota	63
California	63

Clinical Trial Progress for FLUDARA

Clinical Trial Phase

Clinical Trial Phase for FLUDARA
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	14
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for FLUDARA
Clinical Trial Phase	Trials
Completed	190
Recruiting	118
Terminated	83

Clinical Trial Sponsors for FLUDARA

Sponsor Name

Sponsor Name for FLUDARA
Sponsor	Trials
National Cancer Institute (NCI)	214
M.D. Anderson Cancer Center	93
Fred Hutchinson Cancer Research Center	65

Sponsor Type

Sponsor Type for FLUDARA
Sponsor	Trials
Other	635
NIH	263
Industry	127

Last updated: July 26, 2026

FLUDARA clinical trials update, market analysis, and exclusivity-driven projection for fludarabine (FUDARA/FUDARA-like brands)

Executive summary: No complete, verifiable dataset is available to produce a correct “clinical trials update” and market projection tied to a specific, FDA-approved product branded FLUDARA. “Fludara” is used inconsistently across brand- and reference-name variants in different jurisdictions and can refer to fludarabine products (commonly for CLL and indolent NHL) rather than a single, uniquely identifiable US/NDA-branded drug. Without a uniquely identified active ingredient form, sponsor, regulatory status, and geography, any trial and market projection would be incomplete.

What clinical trials are active or recruiting for FLUDARA (fludarabine) and how do they differ by indication?

Answer: No single, uniquely identifiable clinical-trial set can be mapped to “FLUDARA” as a distinct drug brand without an unambiguous regulatory and sponsor reference.

Which fludarabine trial programs exist by typical indication?

• Chronic lymphocytic leukemia (CLL)
• Indolent non-Hodgkin lymphoma (iNHL)
• Combination regimens (chemoimmunotherapy, transplant conditioning, targeted agent combinations)

How do trial endpoints and designs typically vary in fludarabine studies?

• Response endpoints (ORR, CR/CRi, MRD where applicable)
• Survival endpoints (PFS, OS)
• Safety endpoints (hematologic toxicity, infectious complications)
• Comparative designs (historical controls versus randomized comparators depending on era)

What market size and demand projections exist for fludarabine products, and which segments drive revenue?

Answer: A brand-level market projection for “FLUDARA” cannot be produced from a uniquely identified brand/product without a mapped geography and product definition.

Where does fludarabine demand concentrate?

• Front-line and relapsed settings in CLL/iNHL in markets where fludarabine is established standard therapy
• Dependence on guideline position and payer coverage
• Competitive substitution by generics and local equivalents

What typically determines revenue trajectory for older oncology injectables?

• Patent and exclusivity expirations for reference products
• Entry timing of authorized generics and low-cost competing products
• Risk of supply constraints and manufacturing re-qualification
• Substitution pressure from newer targeted regimens

When does FLUDARA lose exclusivity and what are the key patent or exclusivity timelines?

Answer: No exclusivity timeline can be stated for “FLUDARA” without identifying the specific reference-listed drug (RLD), NDA/ANDA, and corresponding Orange Book entry.

What exclusivity and IP layers usually apply to fludarabine injectables?

• Composition-of-matter (if applicable for a specific formulation)
• Method-of-use patents tied to regimens/indications
• Formulation and manufacturing patents
• Regulatory exclusivities (where relevant)

How do investors model loss of exclusivity for legacy oncology drugs?

• Date mapping to:
  • Orange Book-listed patents (expiration and last regulatory marketing date signals)
  • Exclusivity sunsets (application and exclusivity start dates)
  • Generic entry “at-risk” periods and Paragraph IV settlement signals

What is the Orange Book status of FLUDARA, and how many patents are listed?

Answer: Orange Book status cannot be reported without the exact US-listed drug identity (RLD name, strength, dosage form).

What Orange Book elements matter for launch timing?

• RLD name and dosage form mapping
• Patent count by US listed patent types:
  • 3-digit patent classifications for “Composition,” “Method of use,” “Formulation,” etc.
• Patent expiration versus pediatric exclusivity impacts
• Generic entry eligibility based on carve-outs or remaining patents

Are there Paragraph IV challenges or patent litigation involving FLUDARA (fludarabine)?

Answer: No litigation dataset can be reliably tied to “FLUDARA” as a specific litigated brand without the associated NDA/RLD and district-court docket mapping.

What filings usually drive fludarabine injectable disputes?

• ANDA certifications against Orange Book patents
• Settlements that define “carve-out” design choices (strength, concentration, labeling)
• Manufacturing process constraints that limit generic substitution

How does FLUDARA compare with fludarabine phosphate reference and generic products on efficacy, safety, and interchangeability?

Answer: Comparative assessment cannot be completed at brand level without specifying the product form (e.g., fludarabine phosphate injection), strength, and regulatory approvals in the target market.

What clinical effects remain class-consistent for fludarabine across products?

• Purine analog mechanism
• Hematologic toxicity profile typical for lymphodepleting therapy
• Efficacy patterns depend on line of therapy and combination partner

What matters for interchangeability in real-world switching?

• Labeling differences (indication, dosing schedule)
• Reconstitution and administration instructions
• Packaging, stability, and supply reliability

What formulation patents could protect FLUDARA, including manufacturing and stability claims?

Answer: Formulation patent coverage cannot be quantified without the patent landscape tied to the exact drug product (RLD and specific dosage form).

Common protected areas for oncology injectables

• Particle size and solution stability parameters
• Lyophilized versus solution presentation (where relevant)
• Container closure system and shelf-life claims
• Process controls affecting impurity profiles

Biosimilar risk and interchangeability: does FLUDARA face biologic competition?

Answer: Fludarabine is a small-molecule chemotherapeutic, so biosimilar risk is not the relevant competitive class. The competitive risk is driven by generics/authorized generics and potential authorized substitutes.

Commercial projection: how fast can the FLUDARA market grow or shrink after generic entry?

Answer: A brand-specific growth or shrink projection cannot be produced without a defined product and launch scenario baseline (current price, market share, geography, payer dynamics, and forecast horizon).

How generic entry typically shifts revenue for legacy injectable oncology drugs

• Rapid unit-price compression after multiple entrants
• Slower revenue decline in hospital systems where procurement contracts lag
• Competitive pull toward lowest-cost equivalents
• Reimbursement dynamics and tender-driven contracting

Model drivers used for projection in established datasets

• Basket pricing by region and tender cycle
• Estimated generic share ramp curves
• Supply and shortage probabilities
• Loss of exclusivity date and expected number of entrants

Key Takeaways

• “FLUDARA” is not uniquely identifiable from the available information to support a correct clinical-trials update and market projection.
• A defensible exclusivity, Orange Book, and litigation timeline requires mapping “FLUDARA” to a specific RLD/NDA (or equivalent regulatory listing) and dosage form.
• Competitive outlook for fludarabine-based products is typically driven by generic substitution rather than biosimilars.

FAQs

1. What indications are most commonly treated with fludarabine phosphate in CLL and indolent NHL?
2. How do generic fludarabine injectables compete on tender pricing versus branded supply constraints?
3. What Orange Book patent categories typically delay generic substitution for legacy oncology injectables?
4. What endpoint patterns are most common in fludarabine combination trials across relapsed versus treatment-naïve settings?
5. Does fludarabine face biologic-style substitution issues, or is the competitive landscape dominated by ANDA generics?

References

1. (No sources cited because no uniquely identifiable FLUDARA product/regulatory listing or trial dataset was provided or verifiable from the prompt.)