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


Information about CLL


What we are doing to defeat CLL



Dr. Brian Koffman gains insights on phase 1 trials of ibrutinib and idelalisib (CAL 101) from Dr. Richard Furman.


Part I

ASH 2012: Dr. Richard Furman and the Phase 1 trial of Ibrutinib and Idelalisib


Part II

ASH 2012 Dr. Richard Furman discusses what is known and what isn't about the new treatment options.


Andrew Schorr/Patient Power interviews Dr. Susan O'Brien on new oral agents. 

No More FCR? Pill Treatments for CLL Present New Options


Andrew Schorr/Patient Power interviews Dr. Susan O'Brien on B-cell receptor agents.

B-Cell Receptor Agents: Is This the Road to a Cure for CLL? 



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April 2013



Were you fooled on April Fool's Day? There are no jokes here; tremendous progress is being made in CLL research. There are a multitude of new clinical trials, many of which target specific subsets of CLL patients. Below, we discuss some upcoming/ongoing studies and treatment options for the elderly. We also highlight the progress of a grant recipient that is laying the groundwork for future studies.



Treatment for Seniors


It has been awhile since we last discussed CLL treatment in the elderly. We consider this a key topic for several reasons. First, the median age of CLL at diagnosis is 72 years, making the elderly the majority of new CLL patients. Second, traditional chemoimmunotherapy regimens are often too aggressive for elderly patients. Physicians must balance their approach based on tolerability and effectiveness. Third, historically clinical trials have excluded the elderly. By definition, most studies consider 65 and older as elderly. We do not believe this definition to be true for most patients, and other elements such as fitness status and presence of other serious medical conditions need to be considered.


The German CLL study group was one of the first groups to look at how elderly patients considered "fit" responded to traditional chemoimmunoptherapy. Their group and others have shown that older patients who are in excellent condition with limited other medical conditions can be treated with fludarabine based regimens, such as fludarabine, cyclophosphamide and rituximab which is the standard of care regimen for younger patients.



Dr. Alessandra Ferrajoli

(MD Anderson)

Other patients, based on age and other health conditions, may require a less aggressive approach. We have told you about a variety of such approaches in the past, but we wanted to update you about the long-term data. Dr. Alessandra Ferrajoli and her colleagues at MD Anderson conducted a clinical trial giving the immune stimulator GMCSF and rituximab in untreated elderly patients. The study improved the response rate of ritxumab alone. After five years of follow-up, over 80% of the patients were still alive.


Dr. Ferrajoli also looked at lenalidomide (Revlimid) in the treatment of elderly CLL. Lenalidomide is an oral immune modulating agent. The research team found 80% of patients treated with this agent remained alive after five years of follow-up.


The GMCSF and lenalidomide studies described above were initiated several years ago and were examples of studies specifically dedicated to treatment for the elderly; it has taken a number of years to determine if the responses were durable. Dr. Ferrajoli's group is now looking at ofatumumab as initial treatment for the elderly.


What about some of the newer studies? Has the situation changed? Are elderly permitted to enroll? We took a look at recent studies with new agents on clinicaltrials.gov. We were pleasantly surprised to find that age was not an exclusion criteria on many studies. However, elderly are more likely to be excluded based on other comorbidities. Gratifyingly, we found several studies specifically designated for the elderly. For example, there is an ibrutinib vs chlorambucil randomized study specifcally for treatment-na´ve patients 65 or older.  Several cooperative groups, including the German and British groups, are also looking at less aggressive combinations for the elderly using monoclonal antibodies alone or in combination with chemotherapy. Some of these studies are just getting underway. We will update you as data emerges.



Preparing for Future Clinical Trials


Dr. Michael Hallek and his team at the University of Cologne used blood samples from CLL patients to study certain drug combinations in the laboratory. They were hoping to gain clues as to the mechanism of action of the tested drugs which would allow the design of meaningful drug combinations. The group looked specifically at drug induced changes in cell survival and intracellular signaling. 


Dr. Michael Hallek (University of Cologne)

Part of the work looked at mAb37.1, a novel monoclonal antibody directed against CD37, an antigen expressed on the surface of CLL cells similar to CD20, the target of rituximab. According to Hallek, mAb37.1 induced cell death and depleted CLL cells from the blood much more efficiently than rituximab. Based on these results, the group combined mAb37.1 with chemotherapeutic agents fludarabine and chlorambucil. These combination studies in the laboratory continue, but the compound mAb37.1 has moved into a Phase I clinical trial conducted by the German CLL Study Group.


Another component of Dr. Hallek's project is to look at kinase inhibitors that could be used as CLL therapy. They are in the process of developing a tool for determining the effects of certain tyrosine kinase inhibitors that have been effective in chronic myelogenous leukemia (CML). These inhibitors target enzymes that are also involved in CLL cell microenvironment interactions and cellular survival functions.  


courtesy of bbc.co.uk

 The group is also screening laboratory-derived versions of colchicine. Colchicine is found in the seeds of the late blooming, highly-toxic flower, meadow saffron. It is used to treat gout. The drug has been shown to inhibit cell growth and division which makes it a good prospect for cancer therapy; however its toxicity prevents its use as cancer therapy. Dr. Hallek's colleagues are hoping to develop a modified version that is less toxic.



As you can tell, Dr. Hallek's project covers a variety of topics in new drug development. CLL Global has provided over $225,000 in funding over the last three years to support this work. The research group has in turn leveraged the CLL Global funding into an additional $950,000 from two German organizations, showing a true ripple effect of CLL Global's support.





Next month we hope to have additional updates on our grant recipients. Until then, we wish you pleasant spring weather so that you can enjoy your favorite outdoor activities.



CLL Global Research Foundation