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

Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Hematologic Cancer

Phase 1

Withdrawn

Conditions: Leukemia
Myelodysplastic Syndromes
Lymphoma

First Posted Date: 2004-02-16

Last Posted Date: 2020-07-31

Lead Sponsor: Jonsson Comprehensive Cancer Center

Registration Number: NCT00004114

Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Leukemia
Myelodysplastic Syndromes

First Posted Date: 2004-02-16

Last Posted Date: 2010-04-02

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT00027924

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome

Phase 1

Completed

Conditions: Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

First Posted Date: 2004-02-12

Last Posted Date: 2010-03-10

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Registration Number: NCT00077558

Locations: 🇺🇸
M.D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
🇺🇸
Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

and more 1 locations

Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus

Phase 2

Completed

Conditions: Lupus Erythematosus, Systemic

Interventions: Drug: fludarabine phosphate
Drug: cyclophosphamide
Biological: Rituxan (rituximab)
Biological: filgrastim
Drug: methylprednisolone
Other: immunologic technique
Other: laboratory biomarker analysis
Procedure: autologous hematopoietic stem cell transplantation
Drug: Diphenhydramine
Drug: Mesna

First Posted Date: 2004-02-03

Last Posted Date: 2021-01-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 9

Registration Number: NCT00076752

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Phase 1

Completed

Conditions: Leukemia

Interventions: Biological: filgrastim
Biological: oblimersen sodium
Drug: cytarabine
Drug: fludarabine phosphate

First Posted Date: 2004-01-29

Last Posted Date: 2013-02-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 24

Registration Number: NCT00004862

Locations: 🇺🇸
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States

Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

Phase 3

Completed

Conditions: Acute Lymphoblastic Leukemia in Remission
Refractory Hodgkin Lymphoma
Waldenstrom Macroglobulinemia
Acute Myeloid Leukemia in Remission
Aggressive Non-Hodgkin Lymphoma
Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Hematopoietic and Lymphoid Cell Neoplasm
Diffuse Large B-Cell Lymphoma
Indolent Non-Hodgkin Lymphoma
Mantle Cell Lymphoma

Interventions: Procedure: Total-Body Irradiation
Drug: Fludarabine Phosphate
Drug: Mycophenolate Mofetil
Drug: Cyclosporine
Procedure: Peripheral Blood Stem Cell Transplantation

First Posted Date: 2004-01-12

Last Posted Date: 2017-05-15

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 87

Registration Number: NCT00075478

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
VA Puget Sound Health Care System, Seattle, Washington, United States
🇩🇪
Medizinische Univ Klinik Koln, Koln, Germany

and more 7 locations

Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers

Phase 2

Terminated

Conditions: Lymphoma
Leukemia
Myelodysplastic Syndrome
Myeloproliferative Disorders
Multiple Myleoma

Interventions: Drug: Rituximab
Drug: Fludarabine
Drug: Cyclophosphamide
Procedure: Peripheral blood stem cell (PBSC) transplantation
Drug: Etoposide
Genetic: T cell donor lymphocyte infusion (DLI) with unmanipulated donor T cells
Drug: Doxorubicin
Procedure: Allogeneic hematopoietic stem cell transplant (HSCT)
Drug: Vincristine
Drug: Filgrastim
Drug: Prednisone
Genetic: T-Rapa cell Donor Lymphocyte Infusion (DLI)

First Posted Date: 2003-12-15

Last Posted Date: 2018-12-31

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 442

Registration Number: NCT00074490

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States
🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States

Radiolabeled Monoclonal Antibody Therapy, Fludarabine Phosphate, and Low-Dose Total-Body Irradiation Followed by Donor Stem Cell Transplant and Immunosuppression Therapy in Treating Older Patients With Advanced Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Phase 1

Completed

Conditions: Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Previously Treated Myelodysplastic Syndromes
Refractory Anemia With Excess Blasts
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Recurrent Adult Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Untreated Adult Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Chronic Myelomonocytic Leukemia

Interventions: Radiation: iodine I 131 monoclonal antibody BC8
Radiation: total-body irradiation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Drug: fludarabine phosphate
Drug: cyclosporine
Drug: mycophenolate mofetil
Other: laboratory biomarker analysis

First Posted Date: 2003-12-12

Last Posted Date: 2019-11-13

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 79

Registration Number: NCT00008177

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Allogeneic Stem Cell Transplant After ATG, High-Dose Melphalan, and Fludarabine for Patients With Breast Cancer

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Biological: anti-thymocyte globulin
Biological: filgrastim
Biological: graft-versus-tumor induction therapy
Biological: therapeutic allogeneic lymphocytes
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: melphalan
Drug: methotrexate
Procedure: peripheral blood stem cell transplantation