Phase 2 Study of the Activity and Safety of Fludarabine, Cyclophosphamide, and Mitoxantrone plus Rituximab (FCM-R) with Pegfilgrastim (Neulasta) as Frontline Therapy for Patients < 70 Years with Chronic Lymphocytic Leukemia
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 the response to treatment, and increase the time this response lasts, for patients with previously untreated CLL. The safety of this combination will also be studied.
Disease Group: Leukemia
Treatment Agent: Cyclophosphamide
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: Maximum of 4 days in Houston.
Return Visit: At least every 3 months while receiving therapy and 6 to 12 monthly (+/- 3 months) thereafter as long as on study.
Home Care: Chemotherapy courses wil be prescribed by MD Anderson physician or Principal ;Investigator. All chemotherapy may be given by local oncologist except for the ;induction chemotherapy course.
Primary: 1. To determine the clinical response rate (combined morphological [NCI WG criteria] and flow cytometry criteria) following treatment with FCM-R in patients with previously untreated CLL. Secondary: 2. To determine the molecular response rate (PCR for IgH rearrangements) following treatment with FCM-R in patients with previously untreated CLL. 3. To determine time to treatment failure 4. To determine the toxicity profile of FCM-R.
IRB Review and Approval Date: MAR 2,2005
Recruitment Status: Closed
Projected Accrual: N/A
1) Untreated CLL, CLL/PLL, or SLL (small lymphocytic lymphoma) 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).
2) Age < 70 years.
3) Adequate liver function (total bilirubin </= 2.5 mg/dL, 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.
4) Beta-2-microglobulin </= 4 mg/dL.
5) ECOG performance status </= 2.
6) Signed informed consent in keeping with the policies of the hospital.
7) 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.
1) Active hepatitis B (at least one of the following markers positive:
HBsAg, HBeAg, IgM anti-HBc, HBV DNA).
2) Concurrent chemotherapy or immunotherapy.
3) Pregnant patients.
4) History of HIV
5) Symptomatic CNS disease
6) Symptomatic heart disease (NYHA class >/= 3) or LV ejection fraction < 40% (by MUGA or echocardiogram)