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Fludarabine Injection (Fludarabine Phosphate Injection) - Summary



Fludarabine Phosphate for Injection, USP should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Fludarabine Phosphate for Injection, USP can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, Fludarabine Phosphate for Injection, USP was associated with severe neurologic effects, including blindness, coma, and death. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m2/day for 5 to 7 days) than the recommended dose. Similar severe central nervous system toxicity, including coma, seizures, agitation and confusion, has been reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia.

Instances of life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evan's syndrome, and acquired hemophilia have been reported to occur after one or more cycles of treatment with Fludarabine Phosphate for Injection, USP. Patients undergoing treatment with Fludarabine Phosphate for Injection, USP should be evaluated and closely monitored for hemolysis.

In a clinical investigation using Fludarabine Phosphate for Injection, USP in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of Fludarabine Phosphate for Injection, USP in combination with pentostatin is not recommended.



Fludarabine Phosphate for Injection, USP contains fludarabine phosphate, a fluorinated nucleotide analog of the antiviral agent vidarabine.

Fludarabine Phosphate for Injection, USP is indicated 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. The safety and effectiveness of Fludarabine Phosphate for Injection, USP in previously untreated or non-refractory patients with CLL have not been established.

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Media Articles Related to Fludarabine Injection

Opening the door to the cause of myeloid leukemia: Finding the targets of common mutation
Source: Genetics News From Medical News Today [2015.07.24]
Researchers at the University of Birmingham have made a breakthrough in understanding how mutated genes in leukaemia reprogram blood stem cells and send them spiralling out of control.

Stem cell transplantation for children with rare form of leukemia improves outcomes
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.07.24]
Researchers in the Division of Hematology, Oncology and Blood & Marrow Transplantation at Children's Hospital Los Angeles have shown greatly improved outcomes in using stem cell transplantation to...

Access denied: Leukemia thwarted by cutting off link to environmental support
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.07.24]
A new study by researchers at University of California, San Diego School of Medicine reveals a protein's critical - and previously unknown -- role in the development and progression of acute myeloid...

New approach to treating B-cell acute lymphoblastic leukemia shows promise
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.07.14]
A new compound that locks a disease-related protein into an inactive position stifled the growth of an aggressive form of leukemia in laboratory and animal tests, researchers at Dana-Farber Cancer...

Promising drug for childhood acute leukemia -- where to next?
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.07.10]
A new Australian study shows that a recently-developed drug, already used safely in adult leukaemia clinical trials, holds great promise for some children with an aggressive form of cancer known as...

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Published Studies Related to Fludarabine Injection

Clofarabine +/- fludarabine with once daily i.v. busulfan as pretransplant conditioning therapy for advanced myeloid leukemia and MDS. [2011.06]
Although a combination of i.v...

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Clinical Trials Related to Fludarabine Injection

Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab [Recruiting]
This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1: 1 ratio between the 2 treatment arms (55 subjects per arm).

Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL [Recruiting]
The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin [Recruiting]
The goal of this clinical research study is to learn about the safety of AMD3100 (plerixafor) and G-CSF (filgrastim) in combination with fludarabine, busulfan, and an allogeneic blood stem cell transplant. This treatment will be studied in patients with AML, MDS, or CML.


Primary Objective:

1. To determine the safety of Plerixafor and Filgrastim (G-CSF) in combination with busulfan, fludarabine and allogeneic hematopoietic transplantation for treatment of advanced myeloid leukemias.

2. Determine biologic effects of Plerixafor and G-CSF on leukemia cells.

3. To determine if the combination of Plerixafor and G-CSF with busulfan, fludarabine will improve progression free survival post allogeneic stem cell transplantation from an HLA-compatible donor compared to historical controls receiving busulfan-fludarabine alone.

Secondary Objectives:

1. To determine the time to engraftment, the rate and severity of GVHD, and immune reconstitution.

Fludarabine-Based Conditioning for Allogeneic Marrow Transplantation in Aplastic Anemia [Recruiting]
The goal of this clinical research study is to find out the best dose of cyclophosphamide that can be given with fludarabine, antithymocyte globulin (ATG), and low-dose total body irradiation (TBI) to patients before a bone marrow transplant to decrease the risks related to the transplant while not decreasing the effectiveness of the transplant from an unrelated donor.



General: Feasibility and toxicity of employing fludarabine-based conditioning to reduce cyclophosphamide doses and transplant-related toxicity while maintaining (or ideally improving) engraftment and survival in allogeneic donor marrow transplantation from matched (and mismatched) unrelated donors (MUD) in patients with severe aplastic anemia (SAA). The primary endpoint of the study is selection of the optimal CY dose based on Day 100 assessments of graft failure (primary and secondary), major regimen-related toxicity and early deaths.

Primary endpoints of the dose-finding (Phase I) portion of the study: engraftment as well as major regimen-related toxicity and early deaths. The Phase I portion of the study will test cyclophosphamide dose de-escalation.

Primary endpoint of the Phase II portion of the study: two-year post-transplant survival achieved with the level of CY dose reduction selected in the dose-finding portion of the study.


Secondary endpoints of clinical interest include secondary graft failure and acute and chronic GVHD.

Cytarabine, Fludarabine, and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome [Recruiting]
The goal of this clinical research study is to learn if the combination of fludarabine, cytarabine, and gemtuzumab ozogamicin can help to control acute myelogenous leukemia (AML), high-risk myelodysplastic syndrome (MDS), or chronic myeloid leukemia (CML) in myeloid blast crisis. The safety of this drug combination will also be studied.

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Page last updated: 2015-07-24

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