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Progress in Oral CLL Therapies
Progress in Oral CLL Therapies
Dr. Peter Hillmen
European Hemaology Association
Update on ABT199 in CLL
Update on ABT199 in CLL
Dr. John Seymour
European Hemaology Association
How the new paradigm of treatment offers hope to a wide range of CLL patients
How the new paradigm of treatment offers hope to a wide range of CLL patients
Dr. Stephan Stilgenbaur
at European Hematology Association

Hitting a CLL Treatment
Hitting a CLL Treatment "Home Run"

 Dr. Thomas Kipps

at American Society

of Clinical Oncology



Understanding ROR1
Understanding ROR1


Dr. Thomas Kipps

at American Society

of Clinical Oncology


sunscreen  Spraying sunscreen near sources of flame can result in significant burns that require medical treatment.

See FDA Warning  


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June/July 2014  



Summer is flying by too quickly! We hope you are remembering to use sunscreen. June and July have been busy months for the CLL community. CLL Global held its annual Alliance Meeting in June. During the latter part of July, the FDA granted two approvals important to CLL patients and their doctors. Read more below.


Summer Alliance Meeting 


In June, CLL Global hosted its semi-annual Alliance meeting in Stresa, Italy. A committed group of CLL experts gathered to discuss ongoing research and develop future research concepts. The meeting occurs just after the European Hematology Association (EHA) annual meeting which permits the Alliance participants to discuss the newly presented data and to incorporate these findings into future research plans. See the videos on the left for more information from the EHA annual meeting.


Much of the agenda focused on new therapies in development and how to optimally combine agents. Many of the participants discussed the importance of studying combination strategies. The B-cell signaling agents remained a major topic of discussion. For more on ibrutinib and idelalisib, see the articles below. 


As evidenced by the discussion, the physician community continues to debate how to best suppress CLL and achieve long-term control of the disease while minimizing the risk of the disease transforming into Richter's.


Another major topic was the genetics of CLL. Researchers presented on findings based on various subgroups of patients and the role of viruses in driving CLL. 


Representatives from our host country of Italy presented on a variety of topics including the role of the microenvironment, the transformation from monoclonal B-cell lymphocytosis (MBL) to CLL and the important next generation genetics questions.


The common element of each Alliance meeting is the opportunity for scientific presentations and interactions. This Alliance meeting provided another forum for investigators to collaborate, to question and to develop novel ideas.



FDA Approves Zydelig, Expands Imbruvica 


On July 23, the FDA approved Zydelig (idelalisib) for the treatment of patients with relapsed CLL, in combination with rituximab, for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Zydelig is manufactured by Gilead.


FDA stamp The CLL approval was based on a 220-patient study of idelalisib+rituximab vs placebo+rituximab. The study demonstrated improved progression free survival in the idelalisib+rituximab arm.  

Idelalisib was also approved for

for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) or relapsed small lymphocytic lymphoma (SLL) who have received at least two prior  therapies.


The FDA is requiring a Boxed Warning to indicate serious instances of hepatotoxicity, severe diarrhea or colitis, pneumonitis, and intestinal perforation. The most common adverse reactions (incidence greater than or equal to 20%) are diarrhea, pyrexia, fatigue, nausea, cough, pneumonia, abdominal pain, chills, and rash. The most common lab abnormalities (incidence greater than or equal to 30%) are neutropenia, hypertriglyceridemia, hyperglycemia, ALT elevations, and AST elevations.


A week after the FDA approved idelalisib, the agency expanded the use for Imbruvica (ibrutinib) to include patients with chromosome 17p deletion. The approval was partially based on data from 127 participants who had CLL with 17p deletion. Patients were treated with either ibrutinib or ofatumumab. Those treated with ibrutinib experienced a 75 percent reduction in risk of disease progression or death.


Both idelalisib and ibrutinib will likely be approved in Europe soon. The scientific committee of the European Medicines Agency (EMA) adopted a positive opinion on both agents on July 25. The next step is for the European Commission to review the applications. 



Don't Forget Your Skin This Summer 


We are back on our soap box this summer or should we say lotion box. We want to offer our annual reminder to protect yourself with sunscreen this summer. About 15% of CLL patients will develop skin cancer as a secondary malignancy. The most common form of skin cancer in CLL patients is squamous cell carcinoma is but patients also experience basal cell carcinoma, Merkel-cell carcinoma and melanoma. In general, skin cancer is often more aggressive in CLL patients compared with people who have never had cancer, and CLL patients are at a higher risk of developing recurrent skin cancer.


We still do not fully understand why CLL patients have a higher susceptibility to skin cancer. However, we do know that CLL negatively affects the immune system and is associated with deficient DNA repair. Ultimately, this DNA damage may be the culprit behind higher susceptibility. Patients who need treatment for their CLL are at an even greater risk because their immune system is further compromised.


While researchers are working to better understand skin cancers in CLL, we remind you to protect your skin with protective clothing, sunscreen and shade. Be on the lookout for changes to your skin. Don't forget to have a yearly total skin check with a dermatologist.



Thanks for joining us for another issue of Tidbits. Stay cool and safe.


CLL Global Research Foundation