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Project Alpha Is Launched

Date: December 16, 2003

by Chaya Venkat

A Patient Sponsored & Funded Clinical Trial Initiative by CLL Topics

Related Articles:
Project Alpha Kickoff;
Project Alpha Milestones;
Project Alpha Proposal.


The statement from Mayo Clinic is repeated below:

December 16, 2003.

"The Mayo Clinic CLL clinical and research program is honored to embark upon a collaborative effort with CLL Topics, Inc. Philanthropic support from CLL Topics members will provide funding for Dr. Neil Kay and his research team to focus on two investigations:

1) An intervention clinical trial based on biological / immunotherapeutic approaches for high risk early stage CLL patients and

2) Testing of drugs in microenvironments that mimic the CLL host.

These activities will be conducted in partnership with the Mayo Clinic Cancer Center Hematologic Malignancies program, which provides laboratory facilities, internal scientific review and direction for Mayo Clinic investigators."



irisesDr. Neil Kay and his research team do not need an introduction on this website. Their article "Prognosis at Diagnosis" was reviewed recently on CLL Topics, and it echoes our perspective in so many ways. The Mayo Clinic Hematologic Malignancies program has been at the forefront in defining modern prognostic tests and risk stratification of CLL patients. Dr. Kay is a member of the prestigious CLL Research Consortium and has authored several important research papers on CLL, some in collaboration with European CLL experts. Several of us have met with Dr. Kay and his team in recent months, and came away impressed. I have this theory, I think the cold air of Minnesota winters has a special effect of up regulating humanity and compassion, and down regulating business as usual approach to medicine. Be that as it may, we are delighted to be working with the Mayo team and Project Alpha is in good hands with Dr. Kay as our Principal Investigator.

Over the past few months since the original proposal for Project Alpha was published on our website, we contacted many CLL experts for their suggestions and guidance. Our own thoughts about the design and goals of Project Alpha evolved as a result of this feedback. Since Rituxan is getting lots of attention anyway, we decided to use our money to sponsor other promising biologics that might otherwise not get tested soon. Recent reports about potential downside of EPO (The Dark Side of Epoietin) have made me a little cautious about other hematopoietic growth factors such as GM-CSF. Perhaps my caution is unwarranted, but it does not hurt to be more prudent than otherwise with our first project. In the final analysis, two specific projects have been identified, and I would like to describe them briefly. More details will be available later on, after the protocols are fully fleshed out.

The first project is a formal clinical trial for high risk and early stage CLL patients, comprising of an immunotherapy drug followed by a maintenance "cocktail" of chemopreventive drugs to stabilize this poor prognosis sub-group. As you can see, we have changed the subject group from good prognosis patients to poor prognosis patients. There are three reasons why this change was made in the clinical trial design for Project Alpha and it was made based on serious discussions with several experts.

  1. Low risk patients are likely to live many years without needing therapy. How can we prove our kinder and gentler approach to therapy and patient-friendly remission maintenance has actually made a difference? Since by historical norms, high risk patients progress very rapidly and require therapy soon after diagnosis, improvements will be easier to judge. Too many early phase clinical trials are under-powered and their very design makes their findings statistically suspect. We wanted to be sure that does not happen to our project, that the results of the Project Alpha clinical trial are unequivocal, statistically significant and the design, beyond reproach. This is crucial if we want to be able to nurture our project through the regulatory hurdles. I am sure many of you are as frustrated as I am in the time it takes to translate a brilliant idea from the lab to a commercially available therapy option that patients can use.
  2. Equally important, to put it rather bluntly high risk "Bucket C" patients need the help most, and sooner the better. Furthermore, they need to be in early stage because poor prognosis patients, after they have been through the wars of several bouts of heavy duty chemotherapy, are not good candidates for fine tuned biologic and immunotherapy approaches.
  3. Last but not least, if these innovative approaches work with the high risk category patients, the tough nuts to crack so to speak, to my mind it will be a safe bet that they would work that much better with good prognosis patients. When our worst-off members win, that is when we are all likely to win, big time.

I regret I am not at liberty to tell you the identity of the specific immunotherapeutic agent(s) and chemopreventives that will be used in this project, at this point in time. If you are willing to take my word for it, I can tell you I am very pleased with the choices, and optimistic that we will see good efficacy of this combination for CLL patients.

The second project is an effort to develop a method for screening new drug candidates and identify those that have high probability of success in CLL. Drug testing outside the body whether it be in test tubes or mice has not been a satisfactory predictor of performance in real patients. This is because the micro-environment within our bodies is so critical to CLL cell survival that they do not live very long in laboratory test tubes, not long enough to carry out meaningful drug testing. Monoclonal antibodies also serve to increase the complexity of the problem, their mode of action is so different compared to more conventional chemotherapy drugs. Lack of an effective drug screening method has added years and millions of dollars to getting new drugs to the market place. It has also meant that it is hard to tell ahead of time how an individual patient is going to respond to any given therapy, without actually going through the therapy.

The Mayo team has developed a laboratory microenvironment where CLL cells survive a lot longer, by doing a better job of mimicking in-vivo conditions. If successful, it would be of great practical value in speeding up drug testing, identifying effective new drugs, and customizing therapy choices to suit individual patients. In the best of all possible worlds, we will not be shooting blind any more -  we would, instead, be able to make therapy choices based on an understanding of how a particular drug is likely to work in each special situation.

As you can see, both projects have common themes. Both are pragmatic, with emphasis on reducing toxicity to patients, use of modern prognostic testing, emphasis on short-circuiting developmental delays as far as possible and, hopefully, both projects will give us practical value for our hard earned money. I could not be happier with our choice of projects to sponsor and fund, our choice of Dr. Kay and his team as  investigators and our collaboration with the world famous Mayo Clinic.

This is a special moment in the short history of CLL Topics and I am delighted to share it with you. We embarked on this adventure because so many of you wrote and supported this novel concept of patients becoming more proactive in clinical trials. Now we need you to add muscle to that support. We hope you will be generous in the donation of your time, your money and your fund-raising efforts. Together we can make Project Alpha one for the history books.

Chaya Venkat
Founder, CLL Topics




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