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

Antibody Conditioning Regimen For Allogeneic Donor Stem Cell Transplantation Of Patients With Fanconi Anemia

Phase 1

Terminated

Conditions: Severe Aplastic Anemia
Fanconi Anemia

Interventions: Biological: CAMPATH-1H
Biological: Anti-CD45
Drug: Fludarabine
Procedure: Stem cell infusion

First Posted Date: 2008-01-10

Last Posted Date: 2018-05-24

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 5

Registration Number: NCT00590460

Locations: 🇺🇸
Methodist Hospital, Houston, Texas, United States
🇺🇸
Texas Children's Hospital, Houston, Texas, United States

Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer

Phase 2

Completed

Conditions: Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Infection
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Precancerous Condition
Secondary Myelofibrosis

Interventions: Biological: anti-thymocyte globulin
Drug: fludarabine phosphate
Drug: cyclophosphamide
Drug: etoposide
Drug: melphalan
Drug: sirolimus
Drug: methotrexate
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: hematopoietic stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: total-body irradiation

First Posted Date: 2008-01-09

Last Posted Date: 2014-09-10

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 32

Registration Number: NCT00589563

Locations: 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
Banner Good Samaritan Medical Center, Phoenix, Arizona, United States

Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or High-Risk Myelodysplastic Syndrome

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Adult Acute Myeloid Leukemia in Remission
CD45-Positive Neoplastic Cells Present
Refractory Anemia With Ring Sideroblasts
Chronic Myelomonocytic Leukemia
Refractory Anemia With Excess Blasts
Refractory Cytopenia With Multilineage Dysplasia and Ring Sideroblasts
Adult Acute Lymphoblastic Leukemia in Remission
Previously Treated Myelodysplastic Syndrome
Refractory Cytopenia With Multilineage Dysplasia

Interventions: Procedure: Allogeneic Bone Marrow Transplantation
Drug: Cyclophosphamide
Drug: Fludarabine Phosphate
Radiation: Iodine I 131 Monoclonal Antibody BC8
Other: Laboratory Biomarker Analysis
Drug: Mycophenolate Mofetil
Drug: Tacrolimus
Radiation: Total-Body Irradiation

First Posted Date: 2008-01-09

Last Posted Date: 2023-02-09

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 26

Registration Number: NCT00589316

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

Use of Rft5-Dga to Deplete Alloreactive Cells for Pts With Fanconi Anemia After Haploidentical SCT

Phase 1

Terminated

Conditions: FANCONI ANEMIA

Interventions: Procedure: CD34 selected haploidentical PBSCT
Drug: Fludarabine
Biological: T cell infusion
Biological: Campath 1h
Biological: anti-CD45

First Posted Date: 2008-01-04

Last Posted Date: 2014-03-04

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 1

Registration Number: NCT00586274

Locations: 🇺🇸
Texas Children's Hospital, Houston, Texas, United States
🇺🇸
The Methodist Hospital, Houston, Texas, United States

Allogeneic SCT Of Pts With SCID And Other Primary Immunodeficiency Disorders

Phase 1

Terminated

Conditions: Severe Combined Immunodeficiency Disease
Severe Primary Immunodeficiency Disorder
Undefined T Cell Deficiency Disorder
Wiskott-Aldrick Syndrome

Interventions: Biological: Campath -1H
Drug: Fludarabine
Biological: Anti-CD45
Procedure: Stem cell infusion

First Posted Date: 2007-12-21

Last Posted Date: 2013-07-02

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 3

Registration Number: NCT00579137

Locations: 🇺🇸
Texas Children's Hospital, Houston, Texas, United States

Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease

Phase 2

Completed

Conditions: Chronic Granulomatous Disease

Interventions: Drug: Busulfan
Biological: Alemtuzumab
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Cyclosporine
Procedure: Stem Cell Infusion

First Posted Date: 2007-12-21

Last Posted Date: 2018-11-09

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 15

Registration Number: NCT00578643

Locations: 🇺🇸
Texas Children's Hospital, Houston, Texas, United States

Allogeneic Stem Cell Transplantation, Severe Homzygous 0/+Thalassemia or Sever Variants of Beta 0/+ Thalassemia, THALLO

Not Applicable

Terminated

Conditions: Thalassemia

Interventions: Drug: Busulfan
Drug: Fludarabine
Drug: Campath 1H
Drug: Cyclophosphamide
Drug: MESNA

First Posted Date: 2007-12-21

Last Posted Date: 2020-05-01

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 10

Registration Number: NCT00578292

Locations: 🇺🇸
Texas Children's Hospital, Houston, Texas, United States

Reduced Intensity Preparative Regimen Followed by Stem Cell Transplant (FAB)

Phase 1

Terminated

Conditions: Acute Myelogenous Leukemia
Multiple Myeloma
Lymphoproliferative Disorders
Hematologic Diseases
Myelodysplastic and Myeloproliferative Disorders
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
Plasma Cell Dyscrasia

Interventions: Drug: Campath
Drug: Busulfan
Drug: Fludarabine
Procedure: Hematopoietic stem cell infusion
Drug: FK-506

First Posted Date: 2007-12-21

Last Posted Date: 2016-05-04

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 4

Registration Number: NCT00579111

Locations: 🇺🇸
Texas Children's Hospital, Houston, Texas, United States
🇺🇸
The Methodist Hospital, Houston, Texas, United States

A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan

Phase 2

Completed

Conditions: Graft Versus Host Disease
Leukemia
Lymphoma

Interventions: Biological: rituximab
Drug: fludarabine phosphate
Drug: melphalan
Drug: sirolimus
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Radiation: indium In 111 ibritumomab tiuxetan
Radiation: yttrium Y 90 ibritumomab tiuxetan
Other: laboratory biomarker analysis