WARNING
ARRANON (nelarabine) Injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. This product is for intravenous use only.
Neurologic Events
Severe neurologic events have been reported with the use of ARRANON. These events have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of events associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.
Full recovery from these events has not always occurred with cessation of therapy with ARRANON. Close monitoring for neurologic events is strongly recommended, and ARRANON should be discontinued for neurologic events of NCI Common Toxicity Criteria grade 2 or greater.
|
| |
ARRANON SUMMARY
ARRANON®
(nelarabine)
Injection
FOR INTRAVENOUS USE
ARRANON (nelarabine) is a pro-drug of the cytotoxic deoxyguanosine analogue, 9-β- D -arabinofuranosylguanine (ara-G).
ARRANON is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.
|
NEWS HIGHLIGHTS
Published Studies Related to Arranon (Nelarabine)
[Severe liver injury following nelarabine chemotherapy for T-cell lymphoblastic lymphoma] [2009.01]
A 41-year-old man received allogeneic hematopoietic stem cell transplantation for T-cell lymphoblastic lymphoma.Although previous studies reported neurotoxicity as the most frequent and severe toxicity, we also need to consider that severe liver injury might be induced by nelarabine.
FDA drug approval summary: nelarabine (Arranon) for the treatment of T-cell lymphoblastic leukemia/lymphoma. [2008.06]
CONCLUSIONS: On October 28, 2005, the FDA granted accelerated approval for nelarabine for treatment of patients with relapsed or refractory T-ALL/T-LBL after at least two prior regimens. This use is based on the induction of CR. The applicant will conduct postmarketing clinical trials to demonstrate clinical benefit, for example, survival prolongation.
Phase I trial of nelarabine in indolent leukemias. [2008.03.01]
PURPOSE: To test whether nelarabine is an effective agent for indolent leukemias and to evaluate whether there is a relationship between cellular pharmacokinetics of the analog triphosphate and clinical responses... CONCLUSION: Nelarabine is an effective regimen against indolent leukemias, and combining it with fludarabine was most promising. Determination of tumor cell ara-GTP levels may provide a predictive test for response to nelarabine.
Nelarabine. [2008]
Nelarabine is an anticancer prodrug of arabinofuranosylguanine (ara-G), which is metabolized in cells to the cytotoxic metabolite ara-G triphosphate (ara-GTP). Ara-GTP competes with deoxyguanosine triphosphate for incorporation into DNA... Neurological events, which may be severe and irreversible, were the most likely adverse events to limit treatment.
Three new drugs for acute lymphoblastic leukemia: nelarabine, clofarabine, and forodesine. [2007.12]
The search for more effective and safer anti-leukemia therapies has led to the identification of several new agents that show activity against specific types of acute lymphoblastic leukemia (ALL). Recently, three novel purine nucleoside analogues (nelarabine, clofarabine, and forodesine) have shown promising activity in patients with relapsed or refractory ALL...
Clinical Trials Related to Arranon (Nelarabine)
Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma [Recruiting]
In Japan, patients with relapsed or refractory T-ALL/T-LBL represent an extremely small
patient population. While the small number of patients presents a practical limitation to
the size of a clinical trial, patients whose disease has not responded to or has relapsed
after treatment with multiple prior chemotherapy regimens have no accepted standard therapies
available. Japanese leukemia experts have expressed interest in evaluating 506U78 in
Japanese patients with relapsed or refractory T-ALL/T-LBL. In order to obtain safety,
tolerability, and pharmacokinetic data of 506U78 in Japanese patients, this study is designed
to maximize the contribution of each available patient.
Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL [Not yet recruiting]
Nelarabine has shown significant activity in patients with T-cell malignancies. This study
will determine the safety and maximum tolerated dose of the combination of nelarabine,
cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first
relapse of T-LL.
506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL) [Recruiting]
The purpose of this study is to determine whether Nelarabine is effective in the treatment
of patients with T-ALL/NHL in order to achieve a complete remission followed by an early
stem cell transplantation.
Hyper-CVAD Plus Nelarabine in Untreated T-ALL/Lymphoblastic Lymphoma [Recruiting]
The goal of this clinical research study is to learn the effectiveness of intensive
chemotherapy given in combination with nelarabine (followed by maintenance therapy) in the
treatment of patients with T cel ALL and T cell lymphoblastic lymphoma. The safety of this
treatment will also be studied.
Observational Study of Nelarabine in Children and Young Adults [Not yet recruiting]
This international, multicentre, single arm, phase IV study will assess the safety and
efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage
acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has
not responded to or has relapsed following treatment with at least two chemotherapy
regimens. It is a post-authorisation safety study (PASS) conducted for the purpose of
confirming the safety profile and the clinical benefit of nelarabine under licensed
conditions of use. The study is observational, non-interventional, and will include
approximately 40 children and young adults (up to 21 years of age).
|
|
|
|
Page last updated: 2009-10-20
|
