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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.


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia

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Trial Information

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.


Inclusion Criteria:



The patients will have to meet the following inclusion criteria in order to be included in
the study:

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
requirements.

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.

Men:

- 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).

Exclusion Criteria:

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
visit.

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,
allogenic transplant)

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
thrombocytopenia.

13. History of another neoplastic disease during ≥ 5 years unless base cells or
epidermoid carcinoma in situ of cervix or breast recently treated.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety of the association of lenalidomide and dexamethasone in patients with relapsed or refractory CLL

Outcome Description:

The first step will be an interim analysis of toxicity to determine the safety of the first lenalidomide cohort dosage (2.5 mg/day). This analysis will be performed after six subjects complete 3 months of treatment. A second analysis of toxicity will be performed after the second lenalidomide dosage cohort (six patients with 5mg/day) complete 3 months of treatment.

Outcome Time Frame:

At the finalization of the second cycle of the treatment of the last patient (average 5 months of last patient inclusion date)

Safety Issue:

Yes

Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

LENDEX-LLC-09

NCT ID:

NCT01246557

Start Date:

December 2009

Completion Date:

March 2015

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Patients with Chronic Lymphatic Leukemia relapsing or resistant to treatment
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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