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.
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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.
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NEWS HIGHLIGHTS
Published Studies Related to Arranon (Nelarabine)
In vitro efficacy of forodesine and nelarabine (ara-G) in pediatric leukemia. [2011.08.25]
Forodesine and nelarabine (the pro-drug of ara-G) are 2 nucleoside analogues with promising anti-leukemic activity. To better understand which pediatric patients might benefit from forodesine or nelarabine (ara-G) therapy, we investigated the in vitro sensitivity to these drugs in 96 diagnostic pediatric leukemia patient samples and the mRNA expression levels of different enzymes involved in nucleoside metabolism.
[Phase I study of nelarabine in patients with relapsed or refractory T-ALL/T-LBL]. [2011.06]
The safety, tolerability, pharmacokinetics and efficacy of nelarabine were evaluated in adult and pediatric patients with relapsed or refractory T-ALL/T-LBL... Japanese adult and pediatric patients with T-ALL/T-LBL well tolerated nelarabine treatment, warranting further investigation.
Salvage therapy with nelarabine, etoposide, and cyclophosphamide in relapsed/refractory paediatric T-cell lymphoblastic leukaemia and lymphoma. [2010.08]
A combination of 5 d of nelarabine (AraG) with 5 d of etoposide (VP) and cyclophosphamide (CPM) and prophylactic intrathecal chemotherapy was used as salvage therapy in seven children with refractory or relapsed T-cell leukaemia or lymphoma... Our experience supports the safety of giving AraG as salvage therapy in synchrony with etoposide and cyclophosphamide, although neurological toxicity must be closely monitored.
A new high-performance liquid chromatography method determines low production of 9-beta-D-arabinofuranosylguanine triphosphate, an active metabolite of nelarabine, in adult T-cell leukemia cells. [2010.02]
The 9-beta-D-arabinofuranosylguanine (ara-G), an active compound of nelarabine, demonstrates potent cytotoxicity specifically on T-cell malignancies. In cells, ara-G is phosphorylated to ara-G triphosphate (ara-GTP), which is subsequently incorporated into DNA, thereby inhibiting DNA synthesis... The present study is the first to evaluate the potential of ara-G against ATL cells; our results suggest that nelarabine would not be effective against ATL.
Nelarabine for the treatment of patients with relapsed or refractory T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. [2009.10]
Nelarabine (506U78) is a soluble prodrug of 9- Darabinofuranosylguanine (ara-G), a deoxyguanosine derivative. Nelarabine has significant activity in patients with T-cell acute lymphoblastic leukemia (T-ALL) and lymphoma (T-LBL)... Nelarabine is being explored in children and will be explored in the near future in adults with newly diagnosed T-ALL.
Clinical Trials Related to Arranon (Nelarabine)
Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL [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.
Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Nelarabine in Patients With Relapsed/Refractory Lymphoid Malignancies [Recruiting]
The goal of the clinical research study is to find the highest tolerable dose of nelarabine
when given as a continuous infusion to patients with a lymphoid malignancy that has not
responded to, or has come back after treatment with chemotherapy. The safety of this drug
will also be studied.
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 [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).
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.
Reports of Suspected Arranon (Nelarabine) Side Effects
Nervous System Disorder (5),
Blood Creatine Phosphokinase Increased (4),
Muscle Atrophy (3),
Decreased Vibratory Sense (3),
Fall (3),
Nerve Conduction Studies Abnormal (3),
Neuropathy Peripheral (3),
Monoplegia (3),
Dyspnoea (3),
Muscular Weakness (3), more >>
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Page last updated: 2011-12-09
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