From what I can tell, Serono is about to put cladribine (called Mylinax) into phase III clinical trials for treatment of multiple sclerosis.
For those who are interested in becoming participants in the trial, (you know me), I just wanted to issue another short and quick "caution" is all.
Just research carefully.
Remember, it is thought by some that the EBV virus is or may be contributory ITSELF to causation of MS. Let me post this one abstract, is all. Please note that as opposed to Novantrone, if and when cladribine produces an adverse event such as described below, discontinuance of the drug apparently does NOT result in reversal of the adverse condition.
Leuk Lymphoma. 2004 May;45(5):1043-8. Related Articles, Links
Epstein-Barr virus positive large B-cell lymphoma arising in a patient previously treated with Cladribine for hairy cell leukemia.
Bhargava R, Barbashina V, Filippa DA, Teruya-Feldstein J.
Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
We describe the case of a patient treated with 2-chloro-2'-deoxyadenosine, CdA or Cladribine for hairy cell leukemia who subsequently developed an Epstein Barr virus (EBV)-positive polymorphous large B-cell lymphoma (p-LBCL). The time interval between Cladribine therapy and development of p-BCL was 11 months and morphologically resembled an EBV-positive post transplant lymphoproliferative disorder (PTLD). Molecular genetic studies for EBV-clonality by Southern blot hybridization showed a clonal population of infected cells, implying that this was an EBV induced lesion. The chronology of events suggest that Cladribine, a purine analog which has been previously described to induce long-lasting immunodeficiency, can, in some cases, weaken the host defense mechanism to a level at which an innocuous EBV infection may transform the normal lymphoid cells into an aggressive neoplasm. Unlike most methotrexate-related lymphoproliferative disorders (LPDs), which undergo spontaneous remission after discontinuation of therapy, LPDs secondary to purine analogs often fails to resolve after discontinuation of therapy and requires additional therapy. Our patient was treated with rituximab following the diagnosis of p-LBCL, with the goal of improving the pancytopenia to permit chemotherapy. However, the patient failed to show any dramatic improvements in counts, developed systemic symptoms and progressive ascites. He expired 3 weeks after a second dose of rituximab. Cladribine is a potent immunosuppressive agent and should be included with the list of immunosuppressive agents that may be associated with EBV-related B-cell lymphoproliferative disorders.
PMID: 15291365 [PubMed - indexed for MEDLINE]
The difference with this drug, also, is that the appropriate warnings and contraindications HAVE been issued with it, hence please just be aware
. EXAMPLE: http://www.bedfordlabs.com/pdf/124-01.pdf
This is purely as part of and for a person's individual risk assessment (with your physician's input and recommendation) before participating in the trial, if you are considering it.
This is no recommendation, insinuation or opinion of mine whatsoever regarding whether anyone should or should not participate. Nor is it intended as any type of medical recommendation, etc. It is only
intended as an "FYI".
In some cases of MS, it may indeed prove to be a God-send.
EDIT: Well, another FYI. And I'm not sure what to make of this at all right at the moment. Only time will tell, I suppose. Truly, I have no comment or opinion at all on this. The NMSS said this about cladribine back in 2003, but that's all I found from them regarding it. In any event, apparently (from what I read), Serono intends on putting it into clinical trial sometime in 2005.
http://www.nationalmssociety.org/Source ... herapy.asp
• Cladribine (Leustatin®)
Recent studies of cladribine have shown no benefit in MS. Side effects have included infections and bone marrow suppression with reduced platelet counts.