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Study Summary
No. 2004-0102:.......Leukemia......Alessandra Ferrajoli......Leukemia
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Study Summary Title
Study Summary
Number:
2004-0102
Study Title:Rituximab in combination with Sargramostim (GM-CSF) in patients with Chronic Lymphocytic Leukemia (CLL)
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Physician New Patient Referral
Name:Alessandra FerrajoliPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2063
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
One week at the beginning of treatment, then return for one day after three
months, for one day every six months for one year and yearly thereafter.
Treatment
Agents:
GM-CSF
Rituximab
Home Care:After the first week, treatment can be continued at home for weeks two to
eight.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
Outpatient for one week at the beginning of treatment, subsequently one day
return visits.
Description/
Intervention:
The goal of this clinical research study is to learn if giving GM-CSF together
with rituximab can improve the ability of rituximab to shrink or slow the
growth of CLL. The safety of this combination treatment will also be studied.
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Study Objectives / Outcomes
1. To evaluate the overall response rate of repeated doses of rituximab plus GM-CSF in patients with CLL.
2. To evaluate the complete response rate and time to progression of repeated doses of rituximab.
3. To determine the effects of rituximab plus GM-CSF on CD20 antigen expression and soluble CD20 levels.
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Study Status Information
Study Activation / Registration Date:08/12/2004
IRB Review and Approval Date:06/02/2004
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:130
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Group 1. Diagnosis of previously treated B-CLL Rai III-IV or earlier stage disease with evidence of "active disease" as defined by the NCI-sponsored working group 1) weight loss of >10% in prior 6 months, 2) extreme fatigue, 3) fever or night sweats without evidence of infection, 4) worsening anemia or thrombocytopenia, 5) progressive lymphocytosis with a rapid lymphocyte doubling time, 6) marked hypogammaglobulinemia or paraproteinemia, 7) lymphadenopathy >5 cm in diameter.

2) Group 2. Diagnosis of previously untreated B-CLL with Rai stage 0-II disease but high risk for progression based on B2-microglobulin >3.0 mg/mL, or with symptoms or significant fatigue.

3) Group 3. Patients age 70 years of age and older with previously untreated B-CLL and Rai stage III-IV or earlier stage disease with indication for treatment who refused chemotherapy.

4) Age 15 years or above.

5) Adequate renal and hepatic functions (creatinine <2.5 mg/dL, bilirubin <2 mg/dL). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes are eligible, as are patients with elevated bilirubin and history consistent with Gilbert's disease.

6) Performance status <3 (Zubrod Scale).

7) No active viral hepatitis

Exclusion Criteria:1) None.

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Links
Registration Number: NCT00940342
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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