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 Melanoma or Metastatic Kidney Cancer

Phase 2

Completed

Conditions: Kidney Cancer
Melanoma (Skin)

Interventions: Biological: filgrastim
Biological: therapeutic allogeneic lymphocytes
Drug: cyclophosphamide
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2003-01-27

Last Posted Date: 2014-03-07

Lead Sponsor: University of Chicago

Target Recruit Count: 19

Registration Number: NCT00004135

Locations: 🇺🇸
University of Chicago Cancer Research Center, Chicago, Illinois, United States

Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia

Phase 2

Completed

Conditions: Leukemia

First Posted Date: 2003-01-27

Last Posted Date: 2020-04-06

Lead Sponsor: NCIC Clinical Trials Group

Target Recruit Count: 128

Registration Number: NCT00049075

Locations: 🇨🇦
Providence Health Care - Vancouver, Vancouver, British Columbia, Canada
🇨🇦
Saint John Regional Hospital, Saint John, New Brunswick, Canada
🇨🇦
Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada

and more 31 locations

Fludarabine With or Without Cyclophosphamide in Treating Patients With Chronic Lymphocytic Leukemia

Phase 3

Completed

Conditions: Leukemia

First Posted Date: 2003-01-27

Last Posted Date: 2023-06-18

Lead Sponsor: Eastern Cooperative Oncology Group

Target Recruit Count: 280

Registration Number: NCT00003764

Locations: 🇺🇸
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
CCOP - Virginia Mason Research Center, Seattle, Washington, United States

and more 215 locations

Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients Who Have Chronic Lymphocytic Leukemia

Phase 2

Completed

Conditions: Leukemia

Interventions: Biological: filgrastim
Biological: rituximab
Drug: cyclophosphamide
Drug: fludarabine phosphate

First Posted Date: 2003-01-27

Last Posted Date: 2017-10-24

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 39

Registration Number: NCT00003659

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission

Phase 2

Completed

Conditions: Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Secondary Acute Myeloid Leukemia
Adult Acute Myeloblastic Leukemia Without Maturation (M1)

Interventions: Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Drug: fludarabine phosphate
Radiation: total-body irradiation
Drug: cyclosporine
Drug: mycophenolate mofetil
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2003-01-27

Last Posted Date: 2020-01-29

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 17

Registration Number: NCT00045435

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

Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

First Posted Date: 2003-01-27

Last Posted Date: 2023-06-22

Lead Sponsor: Eastern Cooperative Oncology Group

Registration Number: NCT00014508

Locations: 🇺🇸
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
🇺🇸
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States

and more 9 locations

Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib

Phase 2

Completed

Conditions: Recurrent Adult Acute Lymphoblastic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Blastic Phase
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Disease
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Chronic Phase of Disease

Interventions: Drug: Cyclosporine
Drug: Dasatinib
Drug: Fludarabine Phosphate
Drug: Imatinib Mesylate
Drug: Mycophenolate Mofetil
Drug: Nilotinib
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Biological: Therapeutic Allogeneic Lymphocytes
Radiation: Total-Body Irradiation

First Posted Date: 2003-01-27

Last Posted Date: 2020-01-29

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 28

Registration Number: NCT00036738

Locations: 🇺🇸
VA Puget Sound Health Care System, Seattle, Washington, United States
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States

Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL

Phase 2

Terminated

Conditions: Leukemia
Lymphoma

First Posted Date: 2003-01-27

Last Posted Date: 2020-04-10

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 10

Registration Number: NCT00041288

Locations: 🇺🇸
Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
🇺🇸
Simmons Cancer Center - Dallas, Dallas, Texas, United States
🇺🇸
University of Missouri Kansas City School of Medicine, Kansas City, Missouri, United States

and more 20 locations

Stem Cell Transplant Therapy With Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome

Phase 1

Completed

Conditions: Mycosis Fungoides
Sezary Syndrome

Interventions: Other: A matched peripheral donor stem cells
Drug: cyclosporine
Drug: fludarabine
Drug: Campath

First Posted Date: 2003-01-27

Last Posted Date: 2023-11-14

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 5

Registration Number: NCT00047060

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

Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia

Phase 1

Completed

Conditions: Leukemia

First Posted Date: 2003-01-27

Last Posted Date: 2010-04-02

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT00005802

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

Drug Development Updates

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