Hi Karen, My understanding is that it would involve PCR (from blood) testing on a monthly basis. To participate in the trial it will require an initial visit to Ann Arbor and then on an annual basis.
What is very exciting about this trial is that it is not a Big Pharma sponsored trial. Zavie On Thu, Mar 18, 2010 at 3:48 PM, <[email protected]> wrote: > Hi Jerry, > > This is very exciting news - thank you for posting it for us!! I do have > one question about the trial - would it require bmbs or aspirations? I > would like to know exactly what they would require at each 3 month visit, if > possible. Thanks so much for your info. > > Karyn > > ----- Original Message ----- > From: "Zavie Miller" <[email protected]> > To: "cmlh...@googlegroups. com" <[email protected]> > Sent: Thursday, March 18, 2010 11:26:07 AM GMT -07:00 U.S. Mountain Time > (Arizona) > Subject: [CMLHope] CML Combo/Trials...The cure we have been waiting for? > > Jerry Posted this on his CMLNEWDRUG.COM <http://cmlnewdrug.com/> website. > > CML Combo/Trials...The cure we have been waiting for? > > by Jerry Mayfield > > Yesterday (March 17, 2010), I met with Dr. Talpaz about his Combo trials. > The purpose of this post is to share information about these trials with you > all. > > First, I want to share with those who are new to CML, a little background > about Dr. Talpaz. Over the last 30 plus years, first at M. D. Anderson and > now at the University of Michigan Medical Center, Dr. Moshe Talpaz has been > doing research and treating thousands of CML patients. During that time, he > has become world renowned as a researcher and pioneer in the treatment of > CML. He was the first to prove that Interferon could be used effectively in > the treatment of CML. He was one of the original three doctors to first use > Gleevec in the treatment of CML. He was one of the first two doctors to use > Sprycel to treat CML. He regularly travels the world to lecture about the > latest research and treatment for CML. Some call him "The Guru of CML". He > is certainly a superstar in the world of CML research and treatment. > > I have known Dr. Talpaz for 11 years now and I have never seen him more > excited about the prospect of finding a cure for CML. For the last several > years he has talked to me about the prospect of combining the proven immune > stimulation of Interferon with the effective targeted killing of CML cells > by the new tyrosine kinase inhibitors (TKIs) and how these combos might > bring a cure for many CML patients. He is now conducting a > Gleevec/Interferon trial and plans a Sprycel/Interferon trial to start in > the next three months. He has further plans to combine Interferon with > Tasigna and also Bosutinib if it gains FDA approval. Another possible > pathway to a cure that he wants to trial is combining TKIs with Hedgehog > Pathway Inhibitors. Some of these Hedgehog Pathway Inhibitors target the > primitive stem cells that cause CML. These primitive stem cells are not > eliminated by the current drugs used alone. All this is very exciting stuff. > For as long as I have known Dr. Talpaz, he has always had an uncanny ability > to look at the preclinical data about a drug and predict whether it will be > a major player in the CML world. This ability has put him at the forefront > of CML research. I have never seen him more excited about a prospective > trial. He is literally bubbling over with optimism that this strategy will > bring us the cure that we have been waiting for. We should all be very > hopeful for the future. > > Here are answers to some questions about Dr. Talpaz’s Combo Trials: > > 1. How do these trials work? Patients take the drug combination for two > years then stop all CML drugs and are monitored by PCR to see it they remain > CML free. > > 2. Do I have to be PCRU? No you do not have to be PCRU. A three log > reduction defined by Dr. Talpaz as a PCR result if 0.100% or below is > required to participate. > > 3. How much of my time will it take? After the first visit, another in 3 > months and after that every 6 months or yearly. > > 4. Will I have bad side effects form the interferon? No, the dose of > pegylated Interferon used in the trial are miniscule, just a small fraction > of a normal dose. Most patients do not have any significant side effects. > > 5. Are there any other trial centers? No, these trials are located at the > University of Michigan in Ann Arbor Michigan. There may be other doctors > around the world doing similar trials but I do not have the information > about them. > > 6. How do I get more information? Doctor Talpaz requests that you contact > him directly by email at [email protected] Please include these words > in your subject line "CML Combo Trials". > > All this is very exciting but it can’t happen without your help. Patients > must be recruited then remain on the trial for two years before stopping the > drugs. Then they must be followed for several years in order to obtain the > data needed. This is a long process and for the trials to be valid, there > must be a substantial number of participants. Dr. Talpaz says that so far > recruitment has been slow. He has devoted his life to CML. His dream is to > find the cure. This is our chance to help him and at the same time to help > ourselves and the CML community world wide. Please consider doing your part. > > Regards, > > Jerry > > Zavie > - > Zavie Miller (age 71) > 67 Shoreham Avenue > Ottawa, Canada, K2G 3X3 > dxd AUG/99 > INF OCT/99 to FEB/00, CHF > No meds FEB/00 to JAN/01 > Gleevec since MAR/27/01 (400 mg) > CCR SEP/01. #102 in Zero Club > 2.8 log reduction Sep/05 > 3.0 log reduction Jan/06 > 2.9 log reduction Feb/07 > 3.6 log reduction Apr/08 > 3.6 log reduction Sep/08 > 3.7 log reduction Jan/09 > 3.8 log reduction May/09 > 3.8 log reduction Aug/09 > e-mail: [email protected] > Tel: 613-726-1117 > Fax: 613-482-4801 > Cell: 613-282-0204 > Yahoo ID: zaviem > > -- > [CMLHope] > A support group of http://cmlhope.com > ------------------------------------------------- > > You received this message because you are subscribed to the Google Groups > "CMLHope" group. > To post to this group, send email to [email protected] > To unsubscribe from this group, send email to > [email protected] > For more options, visit this group at > http://groups.google.com/group/CMLHope > > -- > [CMLHope] > A support group of http://cmlhope.com > ------------------------------------------------- > > You received this message because you are subscribed to the Google Groups > "CMLHope" group. > To post to this group, send email to [email protected] > To unsubscribe from this group, send email to > [email protected] > For more options, visit this group at > http://groups.google.com/group/CMLHope > > To unsubscribe from this group, send email to cmlhope+ > unsubscribegooglegroups.com or reply to this email with the words "REMOVE > ME" as the subject. > -- Zavie Miller (age 71) 67 Shoreham Avenue Ottawa, Canada, K2G 3X3 dxd AUG/99 INF OCT/99 to FEB/00, CHF No meds FEB/00 to JAN/01 Gleevec since MAR/27/01 (400 mg) CCR SEP/01. #102 in Zero Club 2.8 log reduction Sep/05 3.0 log reduction Jan/06 2.9 log reduction Feb/07 3.6 log reduction Apr/08 3.6 log reduction Sep/08 3.7 log reduction Jan/09 3.8 log reduction May/09 3.8 log reduction Aug/09 e-mail: [email protected] Tel: 613-726-1117 Fax: 613-482-4801 Cell: 613-282-0204 Yahoo ID: zaviem -- [CMLHope] A support group of http://cmlhope.com ------------------------------------------------- You received this message because you are subscribed to the Google Groups "CMLHope" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [email protected] For more options, visit this group at http://groups.google.com/group/CMLHope To unsubscribe from this group, send email to cmlhope+unsubscribegooglegroups.com or reply to this email with the words "REMOVE ME" as the subject.
