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

Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis

Phase 2

Withdrawn

Conditions: Systemic Scleroderma

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

First Posted Date: 2010-01-12

Last Posted Date: 2012-10-31

Lead Sponsor: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Registration Number: NCT01047072

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

Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer

Phase 2

Terminated

Conditions: Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Contiguous Stage II Mantle Cell Lymphoma
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Blastic Phase Chronic Myelogenous Leukemia
Contiguous Stage II Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 3 Follicular Lymphoma
Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma

Interventions: Drug: rituximab
Drug: mycophenolate mofetil
Drug: tacrolimus
Drug: anti-thymocyte globulin
Procedure: allogeneic hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
Biological: graft versus host disease prophylaxis/therapy
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: busulfan
Radiation: total-body irradiation
Biological: graft-versus-tumor induction therapy
Biological: immunosuppressive therapy

First Posted Date: 2010-01-08

Last Posted Date: 2023-09-06

Lead Sponsor: University of Nebraska

Target Recruit Count: 20

Registration Number: NCT01044745

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

Biochemical Correction of Severe EB by Allo HSCT and "Off-the-shelf" MSCs

Phase 1

Completed

Conditions: Epidermolysis Bullosa

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Myeloablative Busulfan
Drug: Anti-thymocyte globulin
Procedure: Mesenchymal stem cell transplantation
Procedure: Bone marrow or umbilical cord blood (UCG) stem cell transplantation
Radiation: Total body irradiation

First Posted Date: 2009-12-16

Last Posted Date: 2024-04-03

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 32

Registration Number: NCT01033552

Locations: 🇺🇸
University of Minnesota Masonic Cancer Center and Medical Center, Minneapolis, Minnesota, United States

Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Phase 2

Terminated

Conditions: Acute Myeloid Leukaemia With Prior Myelodysplastic Syndrome
Acute Myeloid Leukemia in Remission
Acute Myeloid Leukemia With Multilineage Dysplasia
Acute Undifferentiated Leukemia
Recurrent Follicular Lymphoma
T Lymphoblastic Lymphoma
Acute Erythroid Leukemia in Remission
Acute Myeloid Leukemia With FLT3/ITD Mutation
Ph+ ALL
Acute Myeloid Leukemia With Inv(3)(Q21Q26.2); RPN1-EVI1

Interventions: Drug: Cyclophosphamide
Biological: Filgrastim
Drug: Fludarabine Phosphate
Drug: Mycophenolate Mofetil
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Drug: Tacrolimus
Radiation: Total-Body Irradiation

First Posted Date: 2009-12-09

Last Posted Date: 2023-01-23

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 46

Registration Number: NCT01028716

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

Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 2

Completed

Conditions: Leukemia
Lymphoma

Interventions: Biological: rituximab
Drug: busulfan
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methotrexate
Drug: sirolimus
Drug: tacrolimus
Procedure: allogeneic stem cell transplant

First Posted Date: 2009-12-07

Last Posted Date: 2023-05-06

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 68

Registration Number: NCT01027000

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, United States

and more 22 locations

Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia

Phase 1

Completed

Conditions: Juvenile Myelomonocytic Leukemia
Acute Myelogenous Leukemia
Myelodysplastic Syndrome

Interventions: Drug: Anti-Thymocyte Globulin
Drug: Fludarabine
Drug: Isotretinoin
Drug: Busulfan
Drug: GVHD Prophylaxis
Drug: Gemtuzumab Ozogamicin

First Posted Date: 2009-11-25

Last Posted Date: 2021-08-06

Lead Sponsor: Columbia University

Target Recruit Count: 18

Registration Number: NCT01020539

Locations: 🇺🇸
Columbia University Medical Center, New York, New York, United States

Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

Phase 2

Completed

Conditions: MDS
Leukemia
CML
AML

Interventions: Drug: Cytarabine
Drug: Fludarabine

First Posted Date: 2009-11-25

Last Posted Date: 2016-03-15

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 151

Registration Number: NCT01019317

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

Donor Stem Cell Transplant or Bone Marrow Transplant in Treating Patients With Acute Myeloid Leukemia in Remission

Phase 2

Completed

Conditions: Leukemia

Interventions: Biological: anti-thymocyte globulin
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: methotrexate
Procedure: allogeneic hematopoietic stem cell transplantation

First Posted Date: 2009-11-25

Last Posted Date: 2015-12-31

Lead Sponsor: Asan Medical Center

Target Recruit Count: 263

Registration Number: NCT01020734

Locations: 🇰🇷
Inje University - Haeundae Paik Hospital, Busan, Korea, Republic of
🇰🇷
Asan Medical Center - University of Ulsan College of Medicine, Seoul, Korea, Republic of

Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases

Phase 2

Completed

Conditions: Bone Marrow Failure
Osteopetrosis
Fanconi Anemia
Severe Combined Immunodeficiency

Interventions: Drug: Fludarabine
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Alemtuzumab
Drug: Rabbit Anti-thymocyte Globulin
Drug: Horse Anti-thymocyte Globulin

First Posted Date: 2009-11-25

Last Posted Date: 2024-10-31

Lead Sponsor: Columbia University

Target Recruit Count: 38

Registration Number: NCT01019876

Locations: 🇺🇸
Columbia University Medical Center, New York, New York, United States

Mismatched Transplantation Using High-dose Post-transplant Cyclophosphamide

Phase 2

Completed

Conditions: Blood Stem Cell Transplant Failure
Leukemia
Hematologic Malignancies

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Melphalan
Drug: Mesna
Drug: Rituximab
Procedure: Stem Cell Transplantation
Drug: Thiotepa
Drug: Tacrolimus
Drug: Mycofenolate mofetil
Drug: G-CSF

First Posted Date: 2009-11-09

Last Posted Date: 2020-03-25

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 176

Registration Number: NCT01010217

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

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