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

Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: Clofarabine
Drug: Idarubicin
Drug: Cytarabine
Drug: Fludarabine

First Posted Date: 2011-02-03

Last Posted Date: 2020-02-24

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 282

Registration Number: NCT01289457

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

A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

Phase 4

Terminated

Conditions: Lymphocytic Leukemia, Chronic

Interventions: Drug: Cyclophosphamide
Drug: Chlorambucil
Drug: Fludarabine
Drug: Rituximab

First Posted Date: 2011-01-26

Last Posted Date: 2019-03-14

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 26

Registration Number: NCT01283386

Locations: 🇷🇺
City Clinical Hospital #15; Hematology department, Saint-Petersburg, Russian Federation
🇷🇺
Republican clinical hospital named after G.G. Kuvatov, UFA, Russian Federation
🇷🇺
The order of Honour pin Irkutsk regional clinical hospital; Hematology Department, Irkutsk, Russian Federation

and more 5 locations

MAGE-A3/12 Metastatic Cancer Treatment With Anti-MAGE-A3/12 TCR-Gene Engineered Lymphocytes

Phase 1

Terminated

Conditions: Metastatic Cancer
Metastatic Renal Cancer
Metastatic Melanoma

Interventions: Biological: PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes
Drug: Aldesleukin
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2011-01-10

Last Posted Date: 2015-10-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 9

Registration Number: NCT01273181

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

Drosophila-generated CTL

Phase 2

Terminated

Conditions: Metastatic Cutaneous Melanoma

Interventions: Drug: fludarabine
Drug: cyclophosphamide
Drug: Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL
Drug: Aldesleukin

First Posted Date: 2011-01-07

Last Posted Date: 2017-08-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 3

Registration Number: NCT01271907

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

A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status

Phase 4

Terminated

Conditions: Lymphocytic Leukemia, Chronic

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Rituximab

First Posted Date: 2011-01-06

Last Posted Date: 2018-03-20

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 89

Registration Number: NCT01271010

Locations: 🇷🇺
Regional Clinical Oncology Despensary #1; Hematology Department, Krasnodar, Russian Federation
🇷🇺
The order of Honour pin Irkutsk regional clinical hospital; Hematology Department, Irkutsk, Russian Federation
🇷🇺
Kemerovo Regional Clinical Hospital, Kemerovo, Russian Federation

and more 7 locations

A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia

Phase 2

Completed

Conditions: Lymphocytic Leukemia, Chronic

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Rituximab

First Posted Date: 2010-12-21

Last Posted Date: 2018-04-23

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 42

Registration Number: NCT01263704

Locations: 🇮🇱
ASSAF Harofe; Department of Hematology, Rishon Lezion, Israel
🇮🇱
Haemek Medical Center; Hematology Department, Afula, Israel
🇮🇱
Hadassah Ein Karem Hospital; Haematology, Jerusalem, Israel

and more 9 locations

Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Interventions: Biological: Alemtuzumab
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dasatinib
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Etoposide Phosphate
Biological: Filgrastim
Drug: Fludarabine Phosphate
Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Melphalan
Drug: Mercaptopurine
Drug: Methotrexate
Biological: Pegfilgrastim
Other: Pharmacological Study
Drug: Tacrolimus
Drug: Vincristine Sulfate

First Posted Date: 2010-12-08

Last Posted Date: 2023-04-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 66

Registration Number: NCT01256398

Locations: 🇺🇸
Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado, United States
🇺🇸
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
🇺🇸
Longmont United Hospital, Longmont, Colorado, United States

and more 98 locations

Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant

Phase 2

Completed

Conditions: Adult Acute Lymphoblastic Leukemia
Adult Acute Myeloid Leukemia
Adult Diffuse Large B-Cell Lymphoma
Adult Myelodysplastic Syndrome
Adult Non-Hodgkin Lymphoma
Aggressive Non-Hodgkin Lymphoma
Childhood Acute Lymphoblastic Leukemia
Childhood Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia in Remission

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Cyclosporine
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Mycophenolate Mofetil
Procedure: Peripheral Blood Stem Cell Transplantation
Drug: Sirolimus
Radiation: Total-Body Irradiation

First Posted Date: 2010-12-02

Last Posted Date: 2019-12-09

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 77

Registration Number: NCT01251575

Locations: 🇺🇸
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
🇩🇰
Rigshospitalet University Hospital, Copenhagen, Denmark
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

and more 2 locations

Umbilical Cord Blood Transplant for Children With Myeloid Hematological Malignancies

Not Applicable

Completed

Conditions: Myeloid Hematological Malignancies

Interventions: Drug: Busulfan
Drug: Cyclophosphamide
Drug: Fludarabine
Procedure: Cord Blood Stem Cell Infusion

First Posted Date: 2010-11-24

Last Posted Date: 2022-06-08

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 16

Registration Number: NCT01247701

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

Umbilical Cord Blood Transplant for Children With Lymphoid Hematological Malignancies

Not Applicable

Withdrawn

Conditions: Lymphoid Hematological Malignancies
Umbilical Cord Blood Transplant

Interventions: Drug: Cytoxan
Drug: Fludarabine
Radiation: Total Body Irradiation (TBI)
Procedure: Cord Blood Stem Cell Infusion

First Posted Date: 2010-11-24

Last Posted Date: 2013-12-12

Lead Sponsor: Baylor College of Medicine

Registration Number: NCT01247688

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