Status:
COMPLETED
FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
OSI Pharmaceuticals
Genentech, Inc.
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and mitoxantrone plus rituximab, with the growth factor pegylated filgrastim, will improve...
Detailed Description
Fludarabine, cyclophosphamide, and mitoxantrone are chemotherapy drugs that are used in the treatment of CLL. Rituximab is a monoclonal antibody that binds to CLL cells and causes cell death. Pegfilgr...
Eligibility Criteria
Inclusion
- Untreated CLL, CLL/ prolymphocytic leukemia (PLL), or small lymphocytic lymphoma (SLL) with indication for therapy (Indications for therapy include at least one of the following: i) one or more disease-related symptoms \[fever, night sweats, weight loss, pronounced fatigue\]; ii) advanced stage disease (Rai stage \>/= 3 or Binet stage C); iii) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; iv) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; iv) recurrent infections; v) rapid lymphocyte doubling time of \< 6 months).
- Age \< 70 years.
- 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). 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.
- Beta-2-microglobulin \</= 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 postmenopausal or surgically sterilized) need a negative serum or urine pregnancy test within 14 days of study enrollment.
Exclusion
- Active hepatitis B (at least one of the following markers positive: HBsAg, HBeAg, Immunoglobulin M (IgM) hepatitis B core antibody (anti-HBc), Hepatitis B (HBV) DNA).
- Concurrent chemotherapy or immunotherapy.
- Pregnant patients.
- History of HIV
- Symptomatic central nervous system (CNS) disease
- Symptomatic heart disease (NYHA class \>/= 3) or left ventricle (LV) ejection fraction \< 40% (by multiple gated acquisition scan (MUGA) or echocardiogram)
Key Trial Info
Start Date :
March 14 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00254410
Start Date
March 14 2005
End Date
September 14 2017
Last Update
May 1 2019
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030