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

Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Phase 2

Completed

Conditions: Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Myeloid Leukemia in Remission
Childhood Acute Myeloid Leukemia in Remission
Childhood Chronic Myelogenous Leukemia
Childhood Grade III Lymphomatoid Granulomatosis
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)

Interventions: Drug: fludarabine phosphate
Drug: melphalan
Radiation: total-body irradiation
Drug: tacrolimus
Drug: mycophenolate mofetil
Drug: methotrexate
Other: laboratory biomarker analysis
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2012-02-09

Last Posted Date: 2019-09-24

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 94

Registration Number: NCT01529827

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies

Phase 2

Completed

Conditions: Aggressive Non-Hodgkin Lymphoma
Blasts Under 5 Percent of Bone Marrow Nucleated Cells
Loss of Chromosome 17p
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Chronic Lymphocytic Leukemia
Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Hodgkin Lymphoma
Recurrent Mantle Cell Lymphoma

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

First Posted Date: 2012-02-06

Last Posted Date: 2020-01-02

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 47

Registration Number: NCT01527045

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

Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)

Phase 2

Terminated

Conditions: Leukemia
Lymphoma
Myeloma
Myeloproliferative Diseases

Interventions: Drug: Fludarabine
Drug: Melphalan
Drug: Alemtuzumab
Procedure: Stem Cell Infusion
Drug: Tacrolimus
Drug: Methotrexate
Drug: G-CSF
Procedure: Low Dose Donor T-Cells
Procedure: High Dose Donor T-Cells

First Posted Date: 2012-01-25

Last Posted Date: 2016-03-17

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 16

Registration Number: NCT01518153

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

HLA-haploidentical Hematopoietic Stem Cell Transplantation for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors

Phase 1

Conditions: Acute Leukemia
Myelodysplastic Syndrome
Solid Tumors

Interventions: Biological: anti-thymocyte globulin
Biological: filgrastim
Radiation: Total body irradiation
Drug: Fludarabine
Drug: cyclophosphamide
Drug: Tacrolimus
Drug: Mycophenolate mofetil
Drug: Rituximab

First Posted Date: 2012-01-13

Last Posted Date: 2012-01-13

Lead Sponsor: Asan Medical Center

Target Recruit Count: 10

Registration Number: NCT01509300

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

90 Y-BC8-DOTA Monoclonal Antibody, Fludarabine Phosphate, and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase 1

Completed

Conditions: Plasma Cell Myeloma
Refractory Plasma Cell Myeloma

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Cyclosporine
Drug: Fludarabine Phosphate
Drug: Mycophenolate Mofetil
Procedure: Peripheral Blood Stem Cell Transplantation
Radiation: Total-Body Irradiation
Radiation: Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8

First Posted Date: 2012-01-02

Last Posted Date: 2019-12-09

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 15

Registration Number: NCT01503242

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

Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match

Phase 2

Terminated

Conditions: Acute Myelogenous Leukemia
Chronic Myelogenous Leukemia
Aplastic Anemia
Acute Lymphocytic Leukemia
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Multiple Myeloma
Hodgkins Disease
Non-Hodgkins Lymphoma