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A CRC Trial of Rituximab in Combination With Sargramostim (GM-CSF) in Patients With Chronic Lymphocytic Leukemia


Phase 2
15 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

A CRC Trial of Rituximab in Combination With Sargramostim (GM-CSF) in Patients With Chronic Lymphocytic Leukemia


OBJECTIVES:

- Determine the complete and overall response rate in patients with B-cell chronic
lymphocytic leukemia treated with rituximab and sargramostim (GM-CSF).

- Determine the time to progression in patients treated with this regimen.

- Determine the effects of this regimen on CD20 antigen expression and soluble CD20
levels in these patients.

OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to
disease status

Patients receive rituximab IV on days 4, 11, 18, and 25 and sargramostim (GM-CSF)
subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, 40,
43, 45, 47, 50, 52, and 54 (course 1). Patients with responding disease may receive an
additional course of treatment.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of B-cell chronic lymphocytic leukemia meeting 1 of the following criteria:

- Previously treated stage III or IV or earlier stage disease with evidence of
active disease, as defined by ≥ 1 of the following:

- Weight loss > 10% within the past 6 months

- Extreme fatigue

- Fever or night sweats without evidence of infection

- Worsening anemia or thrombocytopenia

- Progressive lymphocytosis with a rapid lymphocyte doubling time

- Marked hypogammaglobulinemia or paraproteinemia

- Lymphadenopathy > 5 cm in diameter

- Previously untreated stage 0-II disease with symptoms or significant fatigue or
at high risk of progression due to of B2 microglobulin > 3.0 mg/mL

- Patients who are ≥ 70 years of age with previously untreated stage III or IV or
earlier stage disease requiring treatment but who refused chemotherapy are
eligible

PATIENT CHARACTERISTICS:

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

Hepatic

- Bilirubin < 2.0 mg/dL* (elevated bilirubin allowed if due to of Gilbert's disease)
NOTE: *Liver dysfunction due to lymphocytic organ infiltration allowed

Renal

- Creatinine < 2.5 mg/dL* NOTE: *Renal dysfunction due to lymphocytic organ
infiltration allowed

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active viral infection (e.g., viral hepatitis)

PRIOR CONCURRENT THERAPY:

Chemotherapy

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Safety Issue:

No

Principal Investigator

Ian W. Flinn, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000450145

NCT ID:

NCT00265915

Start Date:

July 2005

Completion Date:

March 2006

Related Keywords:

  • Leukemia
  • B-cell chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • stage 0 chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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