Overview

FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia

Status:
Completed

Trial end date:
2014-12-01

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 rituximab, with sargramostim (GM-CSF) can help to control previously untreated chronic lymphocytic leukemia (CLL). The safety of this combination will also be studied. This study will evaluate antibody-dependent cellular cytotoxicity (ADCC) and its relationship to response.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

Bayer

Treatments:

Cyclophosphamide
Fludarabine
Fludarabine phosphate
Rituximab
Sargramostim
Vidarabine

Criteria

Inclusion Criteria:

- 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
- Adequate liver function (total bilirubin transaminase (SGPT) 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
- Eastern Cooperative Oncology Group (ECOG) performance status
- 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 Criteria:

- 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