Guest guest Posted February 17, 2006 Report Share Posted February 17, 2006 hallo cheryl ann as i have told lynne we have heard from one of the drs on the board of thr trial 106 that novartis has decided to keep following the patients on the gleevec arm. the interferon arm of this trial was closed after 1 year since almost all patients on this arm switched to gleevec. as far as i understood the decision to continue the trial is not limited in time. when we joined the iris trial it was planned to continue for 5 years. i am now midway through the 6 th year. shalom giora [ ] Trial 106 - Correction Hello Lynn and Everyone, In reviewing the information a bit closer it seems that in fact trial 106 may just well be closed. The information I have seen is that as of their last update on their conditional approval status, which was dated April 2003, they would have had to provide annual updates on trial 106 for three years. In January 2004, they would have provided reports for 2003, In January 2005, they would have reported 2004, and in January 2006, they would have reported for 2005 - three years. If anyone else is getting kicked off the trial or needs assistance, please let me know, maybe I can help put you in touch with the right person at Novartis. Cheers, Peace, Love and light, Cheryl-Anne Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 18, 2006 Report Share Posted February 18, 2006 Hello Giora, This is very good information and I hope it helps Lynn. It would be good for her if they did keep the trial going. The information I am referring to has to do with information available in the U S because of the freedom of access to information. It shows that as far as the FDA is concerned, in order for Novartis to fulfill their obligations for their " conditional " approval, they had to report the outcomes of the patients from trial 106 for three years only. Obviously it would be neat if they kept this going as it would be good for everyone to know. Lets keep our fingers crossed for Lynn! Shalom, Cheryl-Anne > > hallo cheryl ann > as i have told lynne we have heard from one of the drs on the board of thr trial 106 that novartis has decided to keep following the patients on the gleevec arm. the interferon arm of this trial was closed after 1 year since almost all patients on this arm switched to gleevec. > as far as i understood the decision to continue the trial is not limited in time. when we joined the iris trial it was planned to continue for 5 years. i am now midway through the 6 th year. > shalom > giora > [ ] Trial 106 - Correction > > > Hello Lynn and Everyone, > > In reviewing the information a bit closer it seems that in fact trial > 106 may just well be closed. The information I have seen is that as of > their last update on their conditional approval status, which was dated > April 2003, they would have had to provide annual updates on trial 106 > for three years. In January 2004, they would have provided reports for > 2003, In January 2005, they would have reported 2004, and in January > 2006, they would have reported for 2005 - three years. > > If anyone else is getting kicked off the trial or needs assistance, > please let me know, maybe I can help put you in touch with the right > person at Novartis. > > Cheers, Peace, Love and light, > Cheryl-Anne > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 19, 2006 Report Share Posted February 19, 2006 In a message dated 2/18/2006 5:12:29 P.M. Eastern Standard Time, cheryl.simoneau@... writes: as i have told lynne we have heard from one of the drs on the board of thr trial 106 that novartis has decided to keep following the patients on the gleevec arm. the interferon arm of this trial was closed after 1 year since almost all patients on this arm switched to gleevec. > as far as i understood the decision to continue the trial is not limited in time. when we joined the iris trial it was planned to continue for 5 years. i am now midway through Hi, since I am very ill at the moment I have not followed up on the trial information you gave me. I emailed but I was told to contact my trial center, which of course doesn 't want to continue with me. I came down with some awful dizziness and terrible nausea these past four days so I have not felt well enough to battle with Novartis or the hospital. The hospital has not called me either, as the person said she would last week. I don't know which end is up. I just want to feel better so I can pursue this. Thanks everyone, Lynne A. Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.