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

CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies

Phase 1

Completed

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

Interventions: Procedure: Allogeneic Bone Marrow Transplantation
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Biological: Anti-Thymocyte Globulin
Drug: Bendamustine Hydrochloride
Drug: Fludarabine Phosphate
Biological: Inotuzumab Ozogamicin
Drug: Methotrexate
Procedure: Peripheral Blood Stem Cell Transplantation
Biological: Rituximab
Drug: Tacrolimus

First Posted Date: 2012-08-14

Last Posted Date: 2024-07-23

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 27

Registration Number: NCT01664910

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita

Phase 2

Active, not recruiting

Conditions: Aplastic Anemia
Dyskeratosis Congenita
Revesz Syndrome
Hoyeraal Hreidarsson Syndrome

Interventions: Biological: alemtuzumab
Drug: Fludarabine
Drug: Cyclosporins
Drug: Mycophenolate mofetil
Drug: Tacrolimus

First Posted Date: 2012-08-08

Last Posted Date: 2024-08-28

Lead Sponsor: Boston Children's Hospital

Target Recruit Count: 40

Registration Number: NCT01659606

Locations: 🇺🇸
Boston Children's Hospital (pediatric patients), Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute (adult patients), Boston, Massachusetts, United States
🇺🇸
Baylor College of Medicine, Houston, Texas, United States

and more 13 locations

Methoxyamine and Fludarabine Phosphate in Treating Patients With Relapsed or Refractory Hematologic Malignancies

Phase 1

Completed

Conditions: Adult Nasal Type Extranodal NK/T-cell Lymphoma
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma

Interventions: Drug: fludarabine phosphate
Drug: methoxyamine
Other: laboratory biomarker analysis
Other: pharmacological study
Genetic: western blotting
Other: mass spectrometry
Genetic: DNA analysis

First Posted Date: 2012-08-07

Last Posted Date: 2015-08-13

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 20

Registration Number: NCT01658319

Locations: 🇺🇸
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

CD19-specific T-cell for Chronic Lymphocytic Leukemia (CLL)

Phase 1

Completed

Conditions: Leukemia
Advanced Cancers

Interventions: Procedure: Leukapheresis
Drug: Fludarabine
Drug: Cyclophosphamide
Procedure: T-cell Infusion

First Posted Date: 2012-07-31

Last Posted Date: 2017-08-17

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 30

Registration Number: NCT01653717

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Single or Double Donor Umbilical Cord Blood Transplant in Treating Patients With High-Risk Hematologic Malignancies

Phase 2

Withdrawn

Conditions: Accelerated Phase Chronic Myelogenous Leukemia
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Nasal Type Extranodal NK/T-cell Lymphoma

Interventions: Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: umbilical cord blood transplantation
Procedure: double-unit umbilical cord blood transplantation
Radiation: total-body irradiation
Drug: tacrolimus
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2012-07-27

Last Posted Date: 2016-07-14

Lead Sponsor: University of Medicine and Dentistry of New Jersey

Registration Number: NCT01652014

Locations: 🇺🇸
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies

Not Applicable

Recruiting

Conditions: Omenn's Syndrome
Wiskott-Aldrich Syndrome
Bare Lymphocyte Syndrome
SCID
Hemophagocytic Lymphohistiocytosis
Langerhan's Cell Histiocytosis
Reticular Dysgenesis
Common Variable Immunodeficiency
Hyper IgM Syndrome
Griscelli Syndrome

Interventions: Drug: Alemtuzumab 0.3 mg
Drug: Cyclophosphamide
Drug: Melphalan
Drug: Alemtuzumab 0.2 mg
Drug: Fludarabine phosphate 40 mg
Drug: Busulfan
Drug: Fludarabine phosphate 30 mg
Biological: Stem Cell Transplantation
Drug: MESNA

First Posted Date: 2012-07-27

Last Posted Date: 2024-01-26

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 30

Registration Number: NCT01652092

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

Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant

Phase 1

Terminated

Conditions: Recurrent Adult Acute Myeloid Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Donor
Hematopoietic Cell Transplant Recipient
Recurrent Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Therapy-Related Acute Myeloid Leukemia
HLA-A*0201 Positive Cells Present

Interventions: Biological: Aldesleukin
Other: Laboratory Biomarker Analysis
Drug: Cyclophosphamide
Biological: WT1-Sensitized Allogeneic T-Lymphocytes
Drug: Fludarabine Phosphate

First Posted Date: 2012-07-13

Last Posted Date: 2022-07-14

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 47

Registration Number: NCT01640301

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

CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploid Donor Natural Killer Cell Treatment in Older AML in First Complete Remission

Phase 2

Withdrawn

Conditions: Acute Myelogenous Leukemia

Interventions: Biological: CD3-/CD19- natural killer cells
Biological: CD3-CD56+ natural killer cells
Device: CliniMACS® CD3 and CD19 Reagent System
Device: CliniMACS® CD56 Reagent System
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin

First Posted Date: 2012-07-12

Last Posted Date: 2017-12-02

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Registration Number: NCT01639456

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States

A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas

Phase 1

Completed

Conditions: Lymphoma
Renal Cell Carcinoma
Gastrointestinal Tumor
Hepatic Tumor
Wilms Tumor
Clear Cell Carcinoma
Melanoma
Neuroblastoma
Rhabdomyosarcoma
Ewing Sarcoma

Interventions: Drug: alemtuzumab
Drug: fludarabine
Drug: sirolimus
Drug: Busulfan
Drug: melphalan
Biological: stem cells
Device: CliniMACS

First Posted Date: 2012-06-21

Last Posted Date: 2020-10-19

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 23

Registration Number: NCT01625351

Locations: 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies

Phase 2

Terminated

Conditions: Hematologic Malignancies

Interventions: Drug: Fludarabine
Drug: Busulfan
Drug: Thymoglobulin
Radiation: Total Body Irradiation
Biological: Umbilical Cord Blood

First Posted Date: 2012-06-19

Last Posted Date: 2014-02-11

Lead Sponsor: University of Virginia

Target Recruit Count: 6

Registration Number: NCT01622556

Locations: 🇺🇸
University of Virginia, Charlottesville, Virginia, United States

Drug Development Updates

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