Overview

FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years

Status:
Completed
Trial end date:
2017-09-14
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Genentech, Inc.
OSI Pharmaceuticals
Treatments:
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Lenograstim
Mitoxantrone
Rituximab
Vidarabine
Criteria
Inclusion Criteria:

1. 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).

2. Age < 70 years.

3. Adequate liver function (total bilirubin transaminase (SGPT) 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. Beta-2-microglobulin
5. Eastern Cooperative Oncology Group (ECOG) performance status
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.

Exclusion Criteria:

1. 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).

2. Concurrent chemotherapy or immunotherapy.

3. Pregnant patients.

4. History of HIV

5. Symptomatic central nervous system (CNS) disease

6. Symptomatic heart disease (NYHA class >/= 3) or left ventricle (LV) ejection fraction
< 40% (by multiple gated acquisition scan (MUGA) or echocardiogram)