Fludarabine

Generic Name: Fludarabine

Brand Names: Fludara

Drug Type: Small Molecule

Chemical Formula: C_₁₀H_₁₂FN_₅O_₄

CAS Number: 21679-14-1

Unique Ingredient Identifier: P2K93U8740

Background: Fludarabine is a chemotherapeutic agent used in the treatment of hematological malignancies. It is commonly marketed under the brand name Fludara.

Indication: For the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen

Associated Conditions: B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/small lymphocytic lymphoma refractory, Refractory Non-Hodgkin's lymphoma

Associated Therapies: -

Clinical Trials

Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Lymphoma

Interventions: Biological: rituximab
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2008-03-21

Last Posted Date: 2018-10-31

Lead Sponsor: University College, London

Target Recruit Count: 370

Registration Number: NCT00641095

Locations: 🇬🇧
Newcastle Upon Tyne Hospitals NHS Trust, Newcastle-Upon-Tyne, England, United Kingdom
🇬🇧
Pontefract General Infirmary, Pontefract, England, United Kingdom
🇬🇧
Saint Bartholomew's Hospital, London, England, United Kingdom

and more 64 locations

Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

Phase 2

Completed

Conditions: MDS
AML
APLASTIC ANEMIA
MULTIPLE MYELOMA
MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)
ALL
RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA
CML Chronic Phase, Accelerated Phase, or Blast Crisis
CLL

Interventions: Drug: Cyclophosphamide
Drug: fludarabine
Drug: cyclosporine
Drug: methotrexate
Biological: G-CSF

First Posted Date: 2008-03-17

Last Posted Date: 2017-04-06

Lead Sponsor: Beth Israel Deaconess Medical Center

Target Recruit Count: 25

Registration Number: NCT00636909

EL625 in Persistent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 2

Terminated

Conditions: Lymphoma, Small Lymphocytic
Leukemia, Lymphocytic, Chronic

Interventions: Drug: cenersen sodium
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2008-03-14

Last Posted Date: 2012-11-28

Lead Sponsor: David Rizzieri

Target Recruit Count: 20

Registration Number: NCT00636155

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

Cytoxan, Fludara, and Antithymocyte Globulin Conditioning Followed By Stem Cell Transplant in Treating Fanconi Anemia

Phase 1

Completed

Conditions: Fanconi Anemia

Interventions: Biological: Anti-Thymocyte Globulin
Drug: Cyclophosphamide
Drug: Fludarabine
Procedure: Hematopoietic Stem Cell Transplantation
Drug: Methylprednisolone
Drug: Filgrastim
Drug: Cyclosporine
Drug: Mycophenolate Mofetil

First Posted Date: 2008-03-06

Last Posted Date: 2021-10-12

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 31

Registration Number: NCT00630253

Locations: 🇺🇸
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States

Donor Stem Cell Transplant After Busulfan, Fludarabine, and Antithymocyte Globulin in Treating Patients With Hematological Cancer

Phase 2

Completed

Conditions: Myelodysplastic Syndromes
Leukemia
Myelodysplastic/Myeloproliferative Neoplasms

First Posted Date: 2008-03-03

Last Posted Date: 2013-03-26

Lead Sponsor: Asan Medical Center

Target Recruit Count: 52

Registration Number: NCT00627666

Locations: 🇰🇷
Asan Medical Center - University of Ulsan College of Medicine, Seoul, Korea, Republic of

Donor Natural Killer Cell Infusion, Rituximab, Aldesleukin, and Chemotherapy in Treating Patients With Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

Phase 1

Terminated

Conditions: Leukemia
Lymphoma

Interventions: Biological: aldesleukin
Biological: allogeneic natural killer cells
Biological: rituximab
Drug: cyclophosphamide
Drug: fludarabine phosphate

First Posted Date: 2008-02-28

Last Posted Date: 2017-12-28

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 6

Registration Number: NCT00625729

Locations: 🇺🇸
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States

Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia

Phase 2

Completed

Conditions: Acute Myelogenous Leukemia

Interventions: Drug: Fludarabine
Drug: Busulfan
Radiation: Total Body Irradiation
Procedure: Stem Cell Transplant

First Posted Date: 2008-02-26

Last Posted Date: 2016-04-08

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 56

Registration Number: NCT00623935

Locations: 🇺🇸
University of Michigan Cancer Center, Ann Arbor, Michigan, United States

Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis

Phase 1

Completed

Conditions: Systemic Scleroderma
Severe Systemic Sclerosis

Interventions: Drug: fludarabine phosphate
Drug: Mycophenolic Acid
Drug: tacrolimus
Radiation: total-body irradiation
Procedure: bone marrow transplantation
Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation
Procedure: quality-of-life assessment
Other: laboratory biomarker analysis
Other: flow cytometry
Procedure: biopsy

First Posted Date: 2008-02-25

Last Posted Date: 2018-06-04

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 3

Registration Number: NCT00622895

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
Colorado Blood Cancer Institute, Denver, Colorado, United States

Donor Peripheral Stem Cell Transplant, Fludarabine, and Busulfan in Treating Patients With Hematologic Cancers

Phase 2

Completed

Conditions: Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes

Interventions: Drug: busulfan
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2008-02-21

Last Posted Date: 2018-01-10

Lead Sponsor: University of California, Davis

Target Recruit Count: 8

Registration Number: NCT00619645

Locations: 🇺🇸
University of California Davis Cancer Center, Sacramento, California, United States

Reduced Intensity Hematopoietic Cell Transplantation for Patients With Resistant Langerhans Cell Histiocytosis

Phase 2

Terminated

Conditions: Histiocytosis, Langerhans-cell

Interventions: Biological: alemtuzumab
Drug: fludarabine phosphate
Drug: melphalan
Procedure: stem cell transplantation

First Posted Date: 2008-02-20

Last Posted Date: 2017-12-28

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 1

Registration Number: NCT00618540

Locations: 🇺🇸
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States

Drug Development Updates

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