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A Prospective Multicenter Pilot Trial to Evaluate the Efficacy of a Treatment With Fludarabine, Cyclophosphamide, Lenalidomide (FCL) for Advanced Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Patients.

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

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Trial Information

A Prospective Multicenter Pilot Trial to Evaluate the Efficacy of a Treatment With Fludarabine, Cyclophosphamide, Lenalidomide (FCL) for Advanced Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Patients.



- 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 the MTD of
Lenalidomide (FCL). (Phase II)


- To define the toxicity and the infection rate of patients treated with FCL and the
median number of delivered courses of FCL, overall response rate and the
progression-free survival and the relationship between the response and the baseline
biologic factors (IgVH, FISH, ZAP-70, CD38).

- To evaluate the overall response rate (complete and partial responses).

- To evaluate the progression-free survival.

OUTLINE: 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, Cyclophosphamide and at evaluating the (CR) rate of FC given in
combination with the MTD of Lenalidomide (FCL).

All patients will receive six monthly courses of FCL schedule consisting of three days of
Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of
Lenalidomide administration (d1-d14).

After completion of study treatment, patients are followed periodically for up to 18 months.

Inclusion Criteria

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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Maximum tolerated dose of lenalidomide (Phase I)

Outcome Description:

Maximum tolerated dose of lenalidomide given in combination with fludarabine.

Outcome Time Frame:

The MTD of Lenalinomide will be evaluated during the two courses given with the escalated dose of Lenalinomide defined by the respective dose level.

Safety Issue:


Principal Investigator

Roberto Foa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universita Degli Studi "La Sapeinza"


Italy: Ethics Committee

Study ID:




Start Date:

February 2008

Completion Date:

December 2013

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • advanced or progressive chronic lymphocytic leukemia
  • Lenalidomide
  • Fludarabine
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid