The clinical data from a Revlimid study in Chronic Lymphocytic Leukemia ( CLL ) were reported at an oral presentation during the 47th American Society of Hematology (ASH) Meeting.

The study reported that sixteen out of nineteen evaluable patients achieved stable disease or better after treatment with Revlimid, and experienced a median decrease of 61 percent in absolute lymphocyte count ( ALC ), a measure of tumor burden.
Five patients achieved complete response ( CR ), two of the five patients achieving molecular ( CR ). Ten patients achieved partial response ( PR ) and three patients achieved stable disease ( SD ).
Progressive disease ( PD ) was reported in three patients.

Chronic lymphocytic leukemia is a hematological cancer that affects approximately 75,000-100,000 people in the U.S.
About 10,000 new cases of chronic lymphocytic leukemia are diagnosed each year and an estimated 5,000 Americans are expected to die of CLL this year.

Thirty-two relapsed or refractory CLL patients, median age of 64 years ( age range: 47-75 ) were enrolled in the trial with all patients available for toxicity and nineteen patients available for response evaluation.
Revlimid was given at 25mg orally every day for 21 days followed by 7 days of rest on a 28-day cycle. Absolute lymphocyte count ( ALC ) at days 0, 7 and 30 were taken to determine direct anti-CLL effect of Revlimid.
Response was assessed at day 30, and then monthly using the National Cancer Institute-Working Group criteria.
CLL patients with stable disease or better response continued on therapy until complete response and those with progressive disease then received Rituximab at ( 375mg/m2 ) added to Revlimid.

Sixteen out of nineteen patients responded with a median decrease of 61% in absolute lymphocyte count ( ALC ), ( range: 55-70% ).
Three patients achieved complete response with 2 achieving a molecular complete response, ten patients achieved progressive disease and three patients achieved stable disease.
Four patients on treatment are too early for response assessment.
Two patients withdrew consent and five patients received less than two months of therapy due to toxicity.
Progressive disease has been observed in three patients, and therefore have received Rituximab. All three patients have responded to the combination therapy.

Toxicity profile was clinically manageable.

The most common side effect was a flare reaction ( tender swelling of lymph nodes and/or rash ) in almost all patients, and tumor lysis syndrome was noted in two patients.
Grade 3 / 4 toxicities included hematologic toxicities in seven patients and febrile neutropenia in three patients.
While the longest follow up is 12 months, further follow-up and analysis will ascertain the durability of these responses and establish the role of Revlimid as a potential treatment of patients with chronic lymphocytic leukemia.

Source: Celgene, 2005


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