Open Label Multi-center Pilot Phase I/II Non-controlled Clinical Trial to Assess Safety and Efficieecy of the Lenalidomide and Dexamethasone Association in Patients With Chronic Relapse or Treatment Resistant Lymphatic Leukemia Following Treatment Containing Fludarabine.
The patients will have to meet the following inclusion criteria in order to be included in
1. To understand and voluntarily sign an informed consent form.
2. To be ≥ 18 years old upon the signature of the informed consent form.
3. To be able to fulfill the visits program of the study and other protocol
4. To have a CLL documented diagnose (NCI/WG criteria) relapsing or resistant to at
least one prior treatment and not to meet the requirements for an intensive rescue
therapy. Prior treatment(s) will have to include fludarabine.
5. All prior anti-cancer therapies, including radiation, hormonal therapy and surgery,
will have to be interrupted at leas 4 weeks before the treatment in this study.
6. Functional state 0-2 (ECOG).
7. Women with childbearing potential (FCBP) will have to:
understand the teratogenic risk of the study drug. accept the simultaneous use of two
reliable contraception methods or to practice the abstinence of heterosexual
relations during the following periods of time related to this study: 1) during at
least 4 weeks before starting the drug of the study; 2) while participating in the
study; y 3) during at least 4 weeks following the interruption of the study. The two
reliable contraceptive methods will have to include one highly effective (this is,
intrauterine device (IUD), hormonal (pills injections or implants), tubal ligation,
vasectomy of the partner) and an barrier effective additional method (this is, latex
preservative, diaphragm, cervical cap). Women with a childbearing potential will have
to visit a specialist in contraceptive methods if necessary.
Before starting the drug under study: • Women with childbearing potential will have
to undergo two negative pregnancy tests (sensibility of at least 25 mUI/ml) before
starting the drug under study. The first test will take place at the visit date or
within a period of 3 days before starting the drug under study and the second.The
patient will not receive the drug until the investigator has verified that the
results of the tests are negative.
- They will have to accept the use of latex preservatives during sexual relations
with women with childbearing potential while they participate in the study and
during at least one week following the interruption of the study, if it is women
with childbearing potential (FCBP) and no use contraception.
- They will have to accept to refrain from donating blood or semen during their
participation in the study and during at least 28 days following the
interruption of the study.
8. In the event of pregnancy or positive pregnancy test in a participant in the study,
or the partner of a male participant in the study, during his participation, the drug
under study will be immediately interrupted.
9. Capable of receiving Acetyl Salicylic Acid (100 or 300 mg) on a daily basis as
prophylactic anticoagulation. (Patients who do not tolerate ASA may use acenocumarol
or low molecular weight heparin).
Patients will not have to fulfill any of the following exclusion criteria to be included
in the study.
1. Any serious medical disorder, laboratory abnormality or psychiatric disease hindering
the signature of the informed consent by the patient.
2. Pregnant women or in lactation period.
3. Any disorder, including the presence of laboratory abnormalities, which puts the
patient at unacceptable risk if he/she participates in the study or hindered the
capacity to understand the information of the study.
4. Use of any other experimental drug or therapy in the period of 28 days from the base
5. Known hyper-sensibility to thalidomide.
6. Development of erythema nodosum if it is characterized by a descamative eruption
while taken thalidomide or similar drugs.
7. Any prior use of lenalidomide.
8. A concurrent use of other agents or anticancer treatments.
9. HIV-positive or infectious hepatitis type A, B or C.
10. Candidates eligible for intensive rescue therapies (ex. R-CHOP plus alemtuzumab,
11. Richter transformation (active) or CNS participation (active)
12. Any of the following laboratory abnormalities:
Neutrophil absolute count < 0.5 x 109/L Platelet count < 25 x 109/L Calculated
Creatinine Clearance <50 mL/min Total serum bilirubin > higher normal limit (HNL) AST
and ALT >3 x higher normal limit (HNL) Autoimmune non controlled hemolytic anemia or
13. History of another neoplastic disease during ≥ 5 years unless base cells or
epidermoid carcinoma in situ of cervix or breast recently treated.