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Study Summary
No. 2006-0260:.......Lymphoma......Peter McLaughlin......Lymphoma
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Study Summary Title
Study Summary
Number:
2006-0260
Study Title:Single-arm, open-label, phase II trial of rituximab plus sargramostim for the treatment of newly diagnosed follicular B-cell lymphoma in adults
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Physician New Patient Referral
Name:Peter McLaughlinPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LymphomaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:LymphomaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Patients will return to clinic once per week for 8 weeks, then once in month
3, then every 3 months for up to 2 years, and then every 6 months for up to 1
year.
Treatment
Agents:
Leukine
Rituxan
Home Care:Sargramostim may be self administered at home or in the hospital/clinic.
Training will be provided to patients on self administration
Treatment Loc:MDACC + Community Programs (CCOP/Network)
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to learn if RITUXAN® (rituximab)
given with LEUKINE® (sargramostim) can help to control newly diagnosed
follicular B-cell lymphoma. The safety of this drug combination will also be
studied.
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Study Objectives / Outcomes
    Primary:
To determine the safety and efficacy of repeat doses of rituximab plus sargramostim for the treatment of adults with newly diagnosed follicular B-cell lymphoma. The primary endpoint is to assess complete response (CR) at 12 weeks.
    Secondary:
    1. Overall response (OR) rate
    2. Progression-free survival (PFS) at 3 years
    3. Adverse event profile
    4. Survival
      5. To determine the effect of Fc gamma receptor polymorphism on response rate and time to progression of lymphoma patients
    Correlative Study Objective:
    To determine the effect of Fc gamma receptor polymorphism on response rate and time to progression of lymphoma patients treated by combination therapy with rituximab and sargramostim.
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Study Status Information
Study Activation / Registration Date:11/17/2006
IRB Review and Approval Date:09/20/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:52
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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) Patients must have histologically confirmed newly diagnosed follicular B-cell lymphoma.

2) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 20 mm with conventional techniques or as >/= 10 mm with spiral CT scan.

3) Patients should not have received prior therapy of any kind for follicular B-cell lymphoma.

4) Age >/= 18 years. Because no dosing or adverse event data are currently available for the use of rituximab in combination with sargramostim in patients (males or females) <18 years of age, children are excluded from this study.

5) ECOG performance status </= 2 (Karnofsky >/= 60%).

6) Patients must have normal organ and marrow function as defined below: - leukocytes >/= 3,000/microL; - absolute neutrophil count >/= 1,500/microL; - platelets >/= 100,000/microL; -total bilirubin within normal institutional limits; - AST(SGOT)/ALT(SGPT) </= 2.5 X institutional upper limit of normal; - creatinine within normal institutional limits OR - creatinine clearance >/= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

7) Hemoglobin >/= 8.0 gm/dL

8) The effects of rituximab and sargramostim on the developing human fetus at the recommended therapeutic doses are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

9) Ability to understand and the willingness to sign an informed consent document.

Exclusion Criteria:1) Prior therapy of any kind for follicular B-cell lymphoma.

2) Patients may not be receiving any other investigational agents.

3) Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

4) History of allergic reactions attributed to compounds of similar chemical or biologic composition to rituximab or other agents used in the study.

5) Rituximab is contraindicated in patients with known anaphylaxis or IgE-mediated hypersensitivity to murine proteins. Sargramostim is contraindicated in patients with excessive leukemic myeloid blasts, with known hypersensitivity to GM-CSF or yeast-derived components of the recombinant, and for concomitant (or within 24 hours ± of) uses with chemotherapy or radiotherapy.

6) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

7) Pregnant women are excluded from this study.

8) Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions.

9) Patients with evidence of active or prior infection of Hepatitis B are excluded. (Note: Persons vaccinated for Hepatitis B who have positive antibodies are not excluded).

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Links
Registration Number: NCT00411086
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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