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Lenalidomide Is Safe, Effective for CLL

CancerWise - March 2009

In an ongoing study, the oral medication Revlimid® (lenalidomide) is proving to be safe and well-tolerated in elderly patients with chronic lymphocytic leukemia (CLL).

Study results to this point were reported by scientists from M. D. Anderson at the American Society of Hematology annual meeting in December 2008.

"Lenalidomide has a favorable toxicity profile and shows signs of activity against CLL in our Phase II clinical trial to date," says study presenter Alessandra Ferrajoli, M.D., associate professor in M. D. Anderson's Department of Leukemia.

Significance of study

Previously, older people with CLL did not have a clear best option for frontline treatment. Chemo-immunotherapy combinations that are effective in younger patients with CLL carry a risk of complications in patients older than 70, Ferrajoli says.

In addition to its effect on leukemia, Revlimid also modulates T-cell function, which may strengthen the immune system. Patients with CLL often are susceptible to infections because of impaired immune systems.

An added bonus for older patients is that Revlimid is a pill taken by mouth.


Revlimid is approved by the U.S. Food and Drug Administration for treatment of multiple myeloma and some forms of myelodysplastic syndrome. Also, it has shown activity in patients with relapsed CLL.

Study description

At first, patients are given 5 milligrams of Revlimid each day. This is increased by 5 milligrams once a month, up to 25 milligrams per day.

Patients are treated on an outpatient basis. Three monthly visits are required, followed by visits every three months while patients are on therapy.

To participate in the study, a patient must:

  • Have untreated CLL
  • Be 65 or older
  • Be able to take aspirin or another anticoagulant drug daily
  • Not be sensitive to thalidomide or derivatives
  • Not have active cardiovascular disease

Primary results

Forty-three patients have enrolled in the study. The median age of participants is 72.

Of the 35 patients who have received treatment for at least three months:

  • Nineteen (54%) had a partial response
  • Fourteen (40%) had no change
  • Two experienced progression of CLL

Lenalidomide also rapidly reduced the number of circulating lymphocytes — the hallmark of the disease — in patients' blood. Lymphocytes are a type of white blood cell.

Additional results

Patients who took the drug for at least two months were evaluated for side effects.

Of those 39 patients:

  • 10 (26%) had decreased neutrophils (a type of white blood cells) or platelets
  • Three had infections (two had fever, and one had pneumonia)

All patients registered in the study remain alive, and 37 of the 43 are continuing treatment.

What’s next?

If you’re interested in participating in a clinical trial or need more information, call 1-800-392-1611.

— Adapted by Dawn Dorsey from and M. D. Anderson news release

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© 2015 The University of Texas MD Anderson Cancer Center