Status:
COMPLETED
Lenalidomide, Fludarabine & Cyclophosphamide in Advanced Chronic Lymphocytic Leukemia Not Responding to Therapy
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase I - II multicenter, non-comparative, open label study in patients with previously treated CLL aimed at defining the MTD of Lenalidomide given in combination with Fludarabine, Cyclophos...
Detailed Description
OBJECTIVES: Primary * To define the maximum tolerated dose (MTD) of Lenalidomide given in combination with FC.(Phase I) * To evaluate the complete remission (CR) rate of FC given in combination with...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age \>=18 years.
- Able to adhere to the study visit schedule and other protocol requirements.
- Patients with advanced stage or progressive CLL (NCI criteria) and relapsed or refractory disease.
- No more than 2 previous different treatment lines.
- No treatment with Campath-1H in the previous 6 months.
- Disease-free of prior malignancies for \>=5 years, with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
- All previous cancer therapy, including chemotherapy, immunotherapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
- ECOG performance status of \<=2 at study entry.
- Laboratory test results within these ranges:
- Serum creatinine \<=1.5 mg/dL and creatinine clearance ≥60mL/min
- Total bilirubin \<=1.5 mg/dL
- AST (SGOT) and ALT (SGPT) \<=1.5 x ULN
- Able to take low molecular weight heparin or in alternative, low- fixed-dose warfarin or, in alternative, low-dose aspirin.
- Able to understand and voluntarily sign the informed consent form.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL 10 - 14 days prior to therapy and repeated within 24 hours of starting study. FCBP must agree to use two reliable forms of contraception for at least 28 days before starting study drug; while participating in the study; and for at least 4 weeks after discontinuation from the study.
- Females must agree to abstain from breastfeeding during study participation and for at least 28 days after discontinuation from the study.
- Males must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 4 weeks following discontinuation.
- (Other details regarding pregnancy tests and contraception are reported in the chapter "Eligibility Criteria" within the study protocol).
- Exclusion criteria:
- Treatment with Campath-1H during the previous 6 months.
- Concurrent use of other anti-cancer agents.
- Positive DAT with clinical and laboratory signs of hemolysis, autoimmune thrombocytopenia.
- Known positivity for HIV or active infectious hepatitis.
- Active bacterial, viral, or fungal infection requiring systemic anti-viral, antibiotic or anti-fungal therapy.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females (lactating females must agree not to breast feed while taking Lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Prior history or presence of thrombosis, thromboembolism, hearth failure or arrhythmia, neurologic disease and renal insufficiency.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum, desquamating rash while taking thalidomide or similar drugs.
- Any prior use of Lenalidomide
- Lactose intolerance
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00727415
Start Date
February 1 2008
End Date
January 1 2016
Last Update
January 22 2019
Active Locations (23)
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1
Unità Operativa Ematologia 1 - Università degli Studi di Bari
Bari, Italy, 70010
2
Istituto di Ematologia e Oncologia Medica "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, Italy
3
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, Italy, 88100
4
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, Italy, 44100