As infections are a major problem in CLL, it is important to be up to date on all the following vaccines EXCEPT:
1: An annual flu “shot” to reduce the risk of influenza or the flu.
2: Zostavax, a live vaccine to reduce the risk of shingles, a reactivation of herpes zoster or chickenpox.
3: Pneumovax 23 (PPSV23), a weakly immunogenic (stimulating the immune system) vaccine to reduce the risk of respiratory infections from 23 common types of strep pneumonia or pneumococcus.
4: Prevnar 13 (PCV13), a more immunogenic (stimulating the immune system) and effective vaccine to reduce the risk of respiratory infections from 13 common types of strep pneumonia or pneumococcus. When indicated, ideally PCV13 is given first, followed by a dose of PPSV23, at least 1 year later.
5: Tdap or Td (Tetanus and diphtheria) to boost response to tetanus toxoid (a poison made by certain bacteria usually associated with deep wounds and to diphtheria (a serious throat infection), and with Tdap, to pertussis or whooping cough, that is very dangerous for children. Tdap is only given one time to adults.
The correct answer is #2. Precisely because our immune response is weakened even at diagnosis and prior to any treatment, we should never get a live vaccine such Zostavax. Some have accidently received it with no issue, but we don’t know it’s safe and won’t make us ill. The good news is that there are safe inexpensive medications such as acyclovir that can lower our risk of shingles. Other live vaccines to be avoided in CLL are Yellow Fever, MMR (mumps, measles and rubella), the nasal spray flu vaccine and the oral typhoid vaccine.
On August 30, the U.S. Food and Drug Administration (FDA) issued a historic action making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer. The FDA approved Kymriah (tisagenlecleucel) for a form of acute lymphoblastic leukemia (ALL). While this is a not a treatment for CLL, the underlying cellular therapy (CAR-T) is in trials in CLL.
BASICS: Clinical trials Phases
Phase 1– Is the drug safe and what’s the best dose? There is no placebo arm. These are small trials.
Phase 2 – Does the drug work? Is it effective? Medium size trials where there is no placebo or control arm.
Phase 3 – Is it better than the standard of care? These are large trials where there is randomization to either a control arm of standard care or the new therapy. If there is no standard care, there may be a placebo arm.
Phase 4 – What else do we need to know about this already approved drug?
ACRONYM OF THE MONTH
FISH or Fluorescence In Situ Hybridization is a test that looks for a few specific chromosomal changes that may have significance in CLL such as missing the small arm of chromosome 17 (17p deleted).
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