MONTHLY QUIZ: Concerning the reason we got CLL:
- CLL can be familial, but that is rare.
- CLL incidence is increased in those exposed to Agent Orange in Vietnam and elsewhere.
- CLL incidence is increased in those exposed to radiation from Chernobyl.
- CLL is linked to benzene exposure.
- All of the above.
- 1, 2 and 3 are correct.
The correct answer is #6. CLL mostly occurs episodically with no known cause but occasionally CLL runs in families. Agent Orange is a recognized risk for CLL and exposed veterans who develop CLL may be entitled to compensation. Radiation was not considered a risk due to the lack of increase of CLL after Hiroshima, but we now know from the Chernobyl experience, that Hiroshima was the exception due to the very low baseline incidence in of CLL in ethnic Japanese. CLL is more common in Whites and Hispanics than Asians and Blacks. Usually, we don’t know why we got CLL.
NEWS:
- Join CLL Society on August 7th for our webinar, A Brighter Future for CLL: Learn How Your Legacy Can Have a Lasting Impact. August is National Make-a-Will month, and CLL Society will be taking this opportunity to share some helpful information on how easy and important it can be to leave a Legacy gift.
- Join CLL Society on August 29th for our webinar, Immunity and CLL: It’s Complicated but Understandable, with Drs. Jacob Soumerai and Andres Chang. They will explain the complexities of CLL, its impact on the immune system, and strategies for managing associated risks including secondary cancers and common infections.
BASICS: Clinical Trials Phases – This applies to all trials, including those for CLL, any cancer and COVID-19
Phase 1: Is the drug safe and what’s the best dose? There is no placebo arm. These are small trials. While they are officially designed to check for safety, clearly efficacy is also looked for.
Phase 2: Does the drug work? Is it effective? Medium size trials where there may or may not be no placebo or control arms. There also can be different arms with different combinations or sequencing of the drugs.
Phase 3: Is it better than the standard of care (SOC)? These are large trials where there is randomization to either a control arm of standard care or the new therapy. Only when there is no “standard of care,” there might be a placebo arm. This is almost never the case in CLL. Ask if the trial allows “crossover” so that if one progresses on one arm, one can transfer to the other. That’s important because it allows patients to get the benefit of the best treatment, no matter to which arm they were randomized. Phase 3 trials are often “pivotal trials” required by the FDA to decide whether to approve the treatment as a new standard of care.
Phase 4: What else do we need to know about this already approved drug or vaccine or treatment?
WORD OF THE MONTH: Heterogeneity
Heterogeneity is the quality of being diverse in character or content. CLL is a heterogenous disease as we are all different in how our disease progresses and is managed. We say at CLL Society: “If you know one CLL patient, you know one CLL patient.” In clinical trials and in statistics, the concept of heterogeneous populations is critical. Trials must compare “apples to apples.” One easy example is that you can’t compare relapsed CLL patients to frontline CLL patient from different trials. We are all different
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