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NEWLY DIAGNOSED

If you have recently been diagnosed with CLL, you probably have questions. 

  

Information about CLL

 

What we are doing to defeat CLL

 

List of CLL specialists around the world

(Provided by ACOR) 

 

FEATURED VIDEOS 

Patient Power interviews Dr. Peter Hillmen (Leeds, UK) at the European Hematology Association meeting on how to choose long-term treatment strategies for CLL. 

How To Plan Your CLL Treatment Journey Long Term
How To Plan Your CLL Treatment Journey Long Term

 

Patient Power interviews Dr. William Wierda (MD Anderson Cancer Center) at the American Society of Clinical Oncology on prognostic factors important in CLL.

 

How Prognostic Factors Can Help Manage CLL
How Prognostic Factors Can Help Manage CLL

 

A CONTINUING DEBATE

Do specific viruses cause certain cancers? Prior studies have indicated a high percentage of cancers caused by viruses. An article just published in the Journal of Virology suggests that the percentage is much lower than other groups have suggested. A group from MD Anderson Cancer Center looked at 3775 malignant tumor samples and found that many of the "common cancers" were not driven by viruses.

 

However, a separate study publised recently in Blood showed  that several lymphoas are driven by Epstein Barr virus and other viruses.

 

What does this mean for CLL? CLL samples were not specifically referenced in this study. CLL Global has supported work to look at the association of viruses and CLL. One study showed the possible association of 

polyomavirus Merkel cell virus with some cases of CLL. Additional work on this topic is ongoing. Stay tuned. We expect the story to get interesting very soon. 

 

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August 2013 

Greetings! 

 

Most people expect summer to be filled with lazy days. That is far from true for the CLL research community. As you will see below the latter part of 2013 and first part of 2014 should prove to be exciting times in CLL research.
THE HAPPENINGS

 

What is in store in the months ahead?

 

 

The next few months are going to be busy. In early September, the world's CLL experts will be gathering in Germany for the International Workshop on CLL (iwCLL). This biennial event brings together hundreds of CLL experts. We will bring you several videos directly from iwCLL as well as a report on the latest research. Our Sept Tidbits will come out after the iwCLL meeting in order to bring you the latest, most current info.

 

Later in the Fall, CLL Global's board of directors will hold its regular meeting; one of the most significant aspects of that meeting is approving the 2014 budget and providing authorization for awarding additional grants.2013

 

Just as you are getting ready to ring in the New Year, we expect to hear that one if not two new FDA-recognized breakthrough drugs for CLL will be approved by the FDA. See last month's Tidbits for details about the results of the clinical trials conducted for these drugs. A decision on Genentech's new monocloncal antibody GA101, or obinutuzumab, should be received from the FDA by the end of the year. The application is under priority review with a December action date.

 

Pharmacyclics announced July 10 that it filed the new drug application for ibrutinib for relapsed-refractory CLL and mantle cell lymphoma (MCL). The company has asked for priority review which means that FDA's goal is to take action on an application within 6 months. Given FDA's track record of late, an approval in 2013 is certainly possible. Gleevec, or imatinib, for chronic myeloid leukemia (CML) was considered a break-through drug before such a term formally existed, and the drug was approved in less than three months in 2001. More recently, Iclusig, or ponatinib, was approved for CML and acute lymphoblastic leukemia in slightly more than three months at the end of 2012. All this could prove a cause for celebration at the end of 2013 for CLL.

 

We are so excited about all of the ongoing work in CLL that we want to share it with you. In January 2014, we will be gathering our Alliance experts to take the pulse of the current state of CLL research. Then we are hitting the road to share that information with you. We are tentatively planning several patient education forums in conjunction with our friends at Patient Power for early 2014. Stay tuned for the details and locations as the plans are finalized.

CLL IN THE NEWS  

 

Revlimid Study Discontinuation: What does it mean?

 

Many of you have heard the news that Celgene's ORIGIN study was discontinued after the FDA placed it on clinical hold on July 12, 2013. This Phase III study was designed to evaluate the safety and efficacy of Revlimid (lenalidomide) vs chlorambucil as a single agent in previously untreated elderly patients with CLL. The study had an imbalance of deaths in the lenalidomide arm vs. the chlorambucil arm, leading Celgen to discontinueconfusion the study. Since the study discontinuation, the CLL patient community has been buzzing about what the study discontinuation means.

 

This discontinued study, also referred to as the CLL-008 trial, enrolled 450 patients in over 26 countries. The patients had a substantial number of comorbidities such as diabetes, congestive heart failure and renal impairment. In fact, this study enrolled patients who were unable to be treated with more aggressive standard chemo-immunotherapies such as regimens containing fludarabine and bendamustine.

 

Many patients have asked if they should come off lenalidomide treatment. Our strong advice is not to arbitrarily stop taking lenalidomide without talking to your doctor. Many clinical studies have shown that lenalidomide is effective in the treatment of CLL, although the agent is formally approved by the FDA for certain patients with multiple myeloma, myelodysplastic syndroms and mantle cell lymphoma. See these two journal articles for information on studies of lenalidomide in elderly patients: Lenalidomide induces long-lasting responses; Lenalidomide as initial therapy. Celgene reports that all of its other company-sponsored CLL clinical trials with lenalidomide are continuing.

 

According to Dr. Michael Keating, CLL Global President and CEO, the relevance of the Celgene study discontinuation is of very limited consequence to patients in the United States and Europe. The care of patients and access to technology in many of the countries in which the study was conducted is not at the level that you would anticipate in the United States and Western Europe.

 

Keating also noted that the patients included in the study were elderly, including a substantial number of patients over the age of 80. For the "super elderly", previous studies already demonstrated that caution is needed when treating patients over the age of 75.

 

It is unfortunate, Keating continued, that patients who have already made such a long-term time and personal commitment to the protocol are having their treatment discontinued even if they were tolerating it well and benefitting from it.

THANK YOU FOR SUPPORTING US!

Thanks for joining us for another issue of Tidbits. Stay tuned for more to come.
  

Sincerely,


CLL Global Research Foundation