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Study Summary
No. 2005-0512:.......Lymphoma......Felipe Samaniego......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:
2005-0512
Study Title:Phase II Study of Zevalin for the Treatment of Early-Stage Indolent Lymphomas
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Physician New Patient Referral
Name:Felipe SamaniegoPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring 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:
Weekly labs x 12 weeks: Physician visits at 2, 4, and 12 weeks (with completed
labs and test); F/U q 3 months for 2 years, F/U q 6 months for Years 3 and 4.
Treatment
Agents:
90Y-ibritumomab tiuxetanHome Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to find out if giving (Rituxan)
rituximab with 90Y (ibritumomab tiuxetan) (90 Y ZevalinŽ) may be effective in
treating low-grade lymphoma. The safety of this combination treatment will also
be studied.
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Study Objectives / Outcomes
Primary Objectives:

Evaluate the efficacy of Zevalin for treatment of low-grade stage I-II indolent lymphomas.

Main endpoints are response rate, safety, and time to treatment failure in all patients and in responders.

Secondary endpoint is overall survival.
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Study Status Information
Study Activation / Registration Date:06/12/2006
IRB Review and Approval Date:02/15/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:36
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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) New diagnosis of low-grade indolent lymphomas Stage I-II. Patients with multiple skin lesions will be eligible provided that the skin is the only site of involvement.

2) Histology includes Indolent CD20+ lymphomas including: Follicular lymphoma, Extranodal marginal lymphoma of MALT type, Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells), and Splenic marginal B-cell lymphoma (+/- villous lymphocytes).

3) Signed Informed Consent.

4) Age >/= 18 years.

5) Pre-study Zubrod performance status of 0, 1, or 2.

6) Acceptable hematologic status within two weeks prior to patient registration, including: absolute neutrophil count ([segmented neutrophils + bands] x total WBC) >/= 1, 500/mm^3, total lymphocyte count </= 5,000/mm^3 and platelet counts >/= 100,000/mm^3.

7) Female patients who are not pregnant or lactating.

8) Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method).

9) Patients determined to have < 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy).

10) Patient should have at least one lesion measuring >/= 1.5 cm in a single dimension. Measurable cutaneous lesions are allowed.

Exclusion Criteria:1) Presence of CNS lymphoma.

2) Patients with HIV or AIDS-related lymphoma.

3) Patients with pleural effusion.

4) Patients with abnormal liver function: total bilirubin > 2.0 mg/dL.

5) Patients with abnormal renal function: serum creatinine > 2.0 mg/dL.

6) Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional).

7) Impaired bone marrow reserve as indicated by < 15% bone marrow cellularity

8) Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.

9) Major surgery, other than diagnostic surgery, within four weeks.

10) Evidence of transformation in the latest biopsy.

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Links
Registration Number: NCT00493467
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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