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.
Media Articles Related to Fludarabine Injection
Test shown to reduce early chronic lymphocytic leukemia deaths is now available to patients
Source: Health News from Medical News Today [2013.11.30]
SignatureCLL have announced that the first laboratory test ever shown in a clinical trial to improve one year survival rates in cancer is now available to patients with chronic lymphocytic leukemia (also called CLL). The U.S. cancer physician who invented the test and the British scientist who used it to make discoveries in leukemia will offer the test under the trade name SignatuRx™ through their own, newly-formed laboratory company.
Key findings for the prevention, diagnosis, treatment and potential cure for acute myeloid leukemia
Source: Genetics News From Medical News Today [2013.11.27]
Acute myeloid leukemia (AML) is a group of heterogeneous diseases with considerable diversity in terms of genetic abnormalities. Mutations of CEBPA, a tumour suppressor, are found in about 10 per cent of human AML patients.
Drug may enhance the effectiveness of bone marrow transplants for select pediatric leukemia patients
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.11.19]
Combining the drug gemtuzumab ozogamicin (GO) with conventional chemotherapy may improve the outcome of bone marrow transplantation for some children battling high-risk acute myeloid leukemia (AML), according to a study led by St. Jude Children's Research Hospital. The results appear in the current edition of the journal Cancer.
FDA approves Roche's Gazyva (obinutuzumab) for people with previously untreated chronic lymphocytic leukemia (CLL)
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.11.05]
Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced that the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL).
Gazyva Approved for Chronic Lymphocytic Leukemia
Source: MedicineNet Leukemia Specialty [2013.11.04]
Title: Gazyva Approved for Chronic Lymphocytic Leukemia
Category: Health News
Created: 11/1/2013 12:35:00 PM
Last Editorial Review: 11/4/2013 12:00:00 AM
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...
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.
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
1. To determine the time to engraftment, the rate and severity of GVHD, and immune
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
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
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
Secondary endpoints of clinical interest include secondary graft failure and acute and
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.