Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL)
Information source: M.D. Anderson Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Lymphocytic Leukemia; Leukemia
Intervention: Lenalidomide (Revlimid) (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: M.D. Anderson Cancer Center
Official(s) and/or principal investigator(s):
Alessandra Ferrajoli, MD, Principal Investigator, Affiliation: UT M.D. Anderson Cancer Center
The goal of this clinical research study is to learn if lenalidomide (Revlimid®) can help to
control CLL in patients who have already received standard therapy. The safety of
lenalidomide will also be studied.
Official title: Lenalidomide (Revlimid) in Patients With Previously Treated Chronic Lymphocytic Leukemia
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
To assess the activity of lenalidomide in CLL patients who have received prior therapy
To assess the tolerability of lenalidomide in CLL patients who have received prior therapy
Minimum age: 18 Years.
Maximum age: N/A.
1. Patients with B-cell CLL with indications for treatment by National Cancer Institute
(NCI) Working Group criteria or Rai Stage III or IV
2. Patients who have received a minimum of one prior purine analog-based chemotherapy
regimen. Prior treatment with corticosteroids, immunotherapy, monoclonal antibody or
radiation therapy is permitted. All previous cancer therapies, including radiation,
hormonal therapy and surgery must have been discontinued 2 weeks prior to treatment in
this study. Any cytotoxic chemotherapy must be discontinued 4 weeks prior to treatment
in this study.
3. Age more than or equal to 18 years (CLL is not observed in patients less than 18 years
4. Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance
5. Adequate renal function indicated by serum creatinine less than or equal to 2 and
adequate hepatic function indicated as total bilirubin less than or equal to 2 times
the upper limit of normal
6. Understand and sign Informed Consent after the investigational nature, study design,
risks and benefits of the study have been explained
7. Women of child-bearing potential (WCBP): A woman of child-bearing potential (a
sexually mature woman who has not undergone a hysterectomy or who has not been
naturally post-menopausal for at least 24 consecutive months, i. e., who has had menses
at any time in the preceding 24 consecutive months) must have a negative urine
pregnancy test within 7 days of starting study drug.
8. (Continued from #7) In addition, sexually active WCBP must agree to use adequate
contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal
ligation; intra-uterine device; barrier contraceptive with spermicide; or abstinence)
while on study drug. A man must agree not to father a child and agree to use a condom
if his partner is of child-bearing potential, even if he has had a successful
9. Disease free of prior malignancies for 5 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
1. Known sensitivity to thalidomide or its derivatives
2. The development of erythema nodosum as characterized by a desquamating rash while
taking thalidomide or similar drugs.
3. Prior use of lenalidomide
4. Concurrent use of other anti-cancer agents or treatment
5. Known positivity for HIV or infectious hepatitis type A, B or C
6. Pregnant or lactating females
7. A serious medical condition, laboratory abnormality or psychiatric illness that would
pose unacceptable risk to the subject if he/she were to participate in the study or
that would interfere with the ability of the patient to carry out the treatment
program or confine the ability to interpret the data from the study.
8. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood)
9. Active cardiovascular disease as defined by the New York Heart Association class 3 or
Locations and Contacts
UT M.D. Anderson Cancer Center, Houston, Texas 77030, United States
Starting date: December 2005
Last updated: May 31, 2007