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`Table Of Contents Novemberi6,2005;106(ii)
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`Apotex EX. 1005, p. 1
`
`Apotex Ex. 1005, p. 1
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`

`

`8/2/2017
`
`Preliminary Results of a Phase II Study of CC-5013 (Lenalidomide, Revlimid®) in Patients with Cutaneous T-Cell Lymphoma. | Blood Journal
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`Preliminary Results of a Phase II Study of CC-5013 (Lenalidomide, Revlimid®) in Patients with
`Cutaneous T-Cell Lymphoma.
`
`Christiane Querfeld, Timothy M. Kuzel, Joan Guitart, and Steven T. Rosen
`
`Blood 2005 106:3351;
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`Info & Metrics
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`Background: Mycosis fungoides (MF)/Sézary syndrome (SS) represent the most common type of cutaneous T-cell lymphoma (CTCL) comprising 50%
`of cutaneous lymphomas. No treatment cures patients with CTCL and patients ultimately develop advanced or relapsed disease that is refractory to
`standard treatment options. The direct antitumor effects associated with potent anti-angiogenic, anti-inflammatory and T-cell co-stimulatory
`activity and favorable toxicity profile of lenalidomide provided the rationale to use this agent in patients with MF/SS. Preliminary results of this
`ongoing phase II trial indicate encouraging early signs, responses and manageable toxicity.
`
`Methods: The study is designed to accrue 29 evaluable patients. Nine patients have been enrolled between April and August 2005. Eight patients are
`evaluable for response and toxicity. Lenalidomide was administered orally on an outpatient basis. Patients received 25 mg daily for 21 days with 7
`days rest of a 28-day cycle. Patients with stable disease and partial response will continue treatment with a maximum of 2 years if tolerated or
`unless unforeseen toxicities occur. Response was assessed after every cycle using Composite Assessment (CA) of Index Lesion Disease Severity for
`skin lesions, absolute Sézary cell count for quantification of circulating malignant lymphocytes and/or CT scans for evidence of adenopathy or
`visceral disease.
`
`Results: The median patient age was 60 years (range, 47–69) and patients had received a median of 6 prior treatment regimens (range, 2–9).
`Preliminary results indicate that a total of 3 patients (38%) have already experienced an objective response (defined as a CA ratio less than or equal
`to 0.5 with no new clinically abnormal lymph nodes, no progression of existing clinically abnormal lymph nodes, and no new cutaneous tumors)
`after 1 to 3 cycles of therapy. Four patients have achieved a minor response such as regression of cutaneous tumor lesions and cervical
`lymphadenopathy in one patient each, and skin improvement from initial generalized erythroderma to less severe erythema with less scaling and
`remain on therapy. The most common side effects were fatigue (4 patients-grade I) and lower leg edema (3 patients-grade II). GI symptoms (grade I)
`and anemia (grade II) was noted in one patient each. One patient discontinued treatment after one cycle because of neurological symptoms (slurred
`speech) possibly related to the study drug and one patient for progressive disease after 3 cycles following a minor response.
`
`Conclusions: In our study lenalidomide has shown encouraging activity in heavily pretreated patients with advanced MF/SS and a mild toxicity
`profile. Accrual is ongoing. Revlimid® is a registered trademark of Celgene Corporation.
`
`2005, The American Society of Hematology
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`http://www.bloodjournal.org.proxy.lib.ohio-state.edu/content/106/11/3351?sso-checked=true
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`Apotex Ex. 1005, p. 2
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`Article
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`Please Note:
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