The more formal title should be: Randomized phase II results – lenalidomide is not a viable option post-allogeneic stem cell transplant for persistent chronic lymphocytic leukemia (CLL).
So what does this mean?
We know that a non-myeloablative Allogeneic Stem Cell Transplantation or allo-SCT offers a chance for a cure in CLL. Importing a whole new immune system that attacks our chronic lymphocytic leukemia (CLL), seeing it as an unwelcome foreign intruder, can produce long-lasting complete responses for some lucky patients.
We know too that complications of transplants, including infections and graft versus host disease can be killers.
We also know that if there is persistent leukemia post-transplant, the prognosis is not good.
The hope was that adding lenalidomide, an immunomodulator, to tweak the immune system might improve outcomes, but the results were disappointing.
Take Away Points:
- For whole group of transplanted patients, only about ½ were expected to be alive at three years.
- For the whole group, the estimated 3-year PFS or progression-free survival was 38%
- The poor outcomes of those randomized to receive lenalidomide were a major factor in these first two disappointing numbers.
- Median PFS for lenalidomide patients was only 1.9 years; for standard care patients it has not been reached.
- More severe acute graft versus host disease was 4 times as common in those on lenalidomide (43% versus 11%).
What have we learned? There was much hope and good reason to believe that lenalidomide would improve our odds with an allo-HCT, but it doesn’t.
That’s why we need to do trials.
Lenalidomide does improve outcomes with an 80% reduction in disease progression in some maintenance settings. See here, but this is trial was a very different setting.
In the end, allo-HCT is still a viable, if high-risk, high-reward option for some with CLL, but lenalidomide doesn’t help.
Will CAR-T therapy replace transplants on CLL? I suspect that is the direction in which we are moving, but only time and more clinical trials will tell.
Here is a link to the abstract.
Here is my 2-minute fun take on this study. The transcript can be accessed here.
It looks as if we are still waiting for a knockout punch for our CLL.
We are all in this together.
Brian Koffman, MD 8-29-17