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 Followed by Zevalin for Relapsed Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Fludarabine
Drug: Mitoxantrone
Drug: Rituximab
Drug: Zevalin

First Posted Date: 2005-07-14

Last Posted Date: 2014-04-24

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 30

Registration Number: NCT00119730

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 2

Terminated

Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Chronic Myelomonocytic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Refractory Anemia With Excess Blasts in Transformation
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Childhood Myelodysplastic Syndromes
Recurrent Childhood Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)

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

First Posted Date: 2005-07-13

Last Posted Date: 2022-12-12

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 18

Registration Number: NCT00119366

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

Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase 2

Completed

Conditions: Recurrent Mantle Cell Lymphoma
B-cell Chronic Lymphocytic Leukemia
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma

Interventions: Biological: rituximab
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Radiation: yttrium Y 90 ibritumomab tiuxetan
Procedure: peripheral blood stem cell transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Radiation: total-body irradiation

First Posted Date: 2005-07-13

Last Posted Date: 2018-06-29

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 42

Registration Number: NCT00119392

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

Fludarabine, Total-Body Irradiation, and Donor Stem Cell Transplant Followed By Cyclosporine and Mycophenolate Mofetil in Treating Patients With Chronic Myelogenous Leukemia

Phase 1

Completed

Conditions: Leukemia

First Posted Date: 2005-07-13

Last Posted Date: 2010-09-21

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 75

Registration Number: NCT00119340

Locations: 🇺🇸
Seattle Cancer Care Alliance, Seattle, Washington, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇺🇸
Veterans Affairs Medical Center - Seattle, Seattle, Washington, United States

Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

Phase 2

Completed

Conditions: Acute Undifferentiated Leukemia
Angioimmunoblastic T-cell Lymphoma
Childhood Acute Lymphoblastic Leukemia in Remission
Hepatosplenic T-cell Lymphoma
Mast Cell Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Adult Burkitt Lymphoma
Adult Acute Lymphoblastic Leukemia in Remission
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative

Interventions: Biological: alemtuzumab
Radiation: total-body irradiation
Drug: fludarabine phosphate
Drug: cyclosporine
Drug: mycophenolate mofetil
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Biological: graft versus host disease prophylaxis/therapy
Other: laboratory biomarker analysis

First Posted Date: 2005-07-11

Last Posted Date: 2017-05-30

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 12

Registration Number: NCT00118352

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

Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma

Phase 2

Completed

Conditions: Lymphoma, Non-Hodgkin
MALT Lymphoma

Interventions: Drug: Fludarabine
Drug: Rituximab

First Posted Date: 2005-07-04

Last Posted Date: 2016-08-01

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 26

Registration Number: NCT00117156

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
University of Rochester Cancer Center, Rochester, New York, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 1 locations

Total-Body Irradiation, Thiotepa, and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

Phase 1

Completed

Conditions: Leukemia
Myelodysplastic Syndromes

First Posted Date: 2005-06-03

Last Posted Date: 2010-09-21

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 20

Registration Number: NCT00112567

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

Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer

Not Applicable

Completed

Conditions: Acute Undifferentiated Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
AIDS-related Immunoblastic Large Cell Lymphoma
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Immunoblastic Large Cell Lymphoma
Childhood Myelodysplastic Syndromes
Childhood Nasal Type Extranodal NK/T-cell Lymphoma
Chronic Neutrophilic Leukemia

Interventions: Drug: fludarabine phosphate
Radiation: total-body irradiation
Procedure: peripheral blood stem cell transplantation
Drug: cyclosporine
Drug: mycophenolate mofetil
Other: laboratory biomarker analysis

First Posted Date: 2005-06-03

Last Posted Date: 2017-05-24

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 5

Registration Number: NCT00112593

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

Iodine I 131 Tositumomab and Fludarabine Phosphate in Treating Older Patients Who Are Undergoing an Autologous or Syngeneic Stem Cell Transplant for Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase 1

Completed

Conditions: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Splenic Marginal Zone Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma

Interventions: Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
Radiation: iodine I 131 tositumomab
Other: laboratory biomarker analysis
Other: flow cytometry
Genetic: polymerase chain reaction

First Posted Date: 2005-05-04

Last Posted Date: 2014-08-06

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 38

Registration Number: NCT00110071

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

Fludarabine and Radiation Therapy in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Chronic Phase or Accelerated Phase Chronic Myelogenous Leukemia

Phase 2

Completed

Conditions: Leukemia

First Posted Date: 2005-05-04

Last Posted Date: 2011-11-17

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 40

Registration Number: NCT00110058

Locations: 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
Seattle Cancer Care Alliance, Seattle, Washington, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

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