Status:
COMPLETED
FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Bayer
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and rituximab, with sargramostim (GM-CSF) can help to control previously untreated chronic...
Detailed Description
Fludarabine and cyclophosphamide are designed to enter CLL cells and destroy the "machinery" that allows CLL cells to multiply. Rituximab is designed to bind to CLL cells and cause cell death. GM-CSF ...
Eligibility Criteria
Inclusion
- Untreated CLL, CLL/PLL, or SLL (small lymphocytic lymphoma) with indication for therapy. Indications for therapy include at least one of the following: (1) one or more disease-related symptoms \[fever, night sweats, weight loss \> 10% in prior 6 months, pronounced fatigue\]; (2) advanced stage disease (Rai stage \>/= 3 or Binet stage C); (3) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; (4) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; (5) recurrent infections; (6) rapid lymphocyte doubling time of \< 6 months.
- Patients who have been treated with not more than one regimen of immunotherapy (e.g. rituximab, alemtuzumab, rituximab plus alemtuzumab) for a diagnosis of CLL, CLL/PLL, or SLL (small lymphocytic lymphoma).
- Beta-2-microglobulin \</= 4 mg/dL.
- Adequate liver function (total bilirubin \</= 2.5 mg/dL, serum glutamate pyruvate transaminase (SGPT) \</=4 x ULN) and renal function (serum creatinine \</= 2.0 mg/dL and/or creatinine clearance \< 30 mL/hour). Patients with renal or liver dysfunction due to suspected organ infiltration by lymphocytes may be eligible after discussion with the Principal Investigator, but upper limits for creatinine even under these circumstances must be creatinine \< 3mg/dL and bilirubin \< 6 mg/dL. Patients with Gilbert's syndrome may be entered on study with bilirubin levels \</= 4 mg/dL.
- Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
- Signed informed consent in keeping with the policies of the hospital.
- Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female patients of childbearing potential (non-childbearing is defined as \>/= 1 year after menses cease and/or surgically sterilized) need a negative serum or urine pregnancy test within 2 days of study enrollment..
Exclusion
- Active hepatitis B (at least one of the following markers positive: HBsAg, hepatitis B e antigen (HBeAg), immunoglobulin M (IgM) anti-HBc, hepatitis B virus (HBV) DNA).
- Concurrent chemotherapy or immunotherapy.
- Pregnant patients.
- History of HIV
- Symptomatic central nervous system (CNS) disease
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00381004
Start Date
September 1 2006
End Date
December 1 2014
Last Update
January 14 2016
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030