Leukemia
Bexxar Consolidation CLL or SLL (PSOC 2301)
A Study of 131-Tositumomab (Bexxar) Consolidation In Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma In First Remission
| Status | Conditions | Phase | Study ID |
| Recruiting | Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma |
Phase II |
PSOC 2301 NCT00476047 |
Summary
This study is evaluating the use of radioimmunotherapy (Bexxar®) in patients who have achieved a first remission following chemotherapy (ex. Fludarabine and Rituximab, Fludarabine,Cyclophosphamide,Rituximab, etc...) to try and eliminate any remaining disease and to lower the chance of the CLL from returning. Radioimmunotherapy uses an antibody that is designed to target specific cancer cells such as the CLL cells, and deliver a small targeted dose of radiation to them. In this study we will gather more information about the safety and effectiveness of using a radiolabeled antibody therapy, 131 I-tositumomab, also called Bexxar® after standard therapy.
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Eligibility Criteria (must meet the following to participate in this study)
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with CD20+ CLL/SLL that prior to first treatment had either Rai stage III/IV disease or Rai stage I/II with evidence of disease activity as defined by the NCI 1996 guidelines
- Patient has received prior therapy and is in 1st remission with a partial or complete response to treatment.
- Patients may have no more than 25% marrow space involvement by CLL/SLL
- Patient must be age 18 or older.
- Patient must have a ECOG performance status of 0, 1 or 2
- Patient must have an anticipated (untreated) survival of at least 3 months.
- Patient must have adequate:
- Bone Marrow Function: ANC ≥ 1,500/µL, platelets ≥ 100,000/µL within 14 days of dosimetric infusion.
- White blood count less than or equal to 20,000/mm3
- Serum creatinine <2 times upper limit of normal.
- Total bilirubin <2 times upper limit of normal, AST <5 times upper limit of normal.
- Males and females must agree to use a contraceptive method from enrollment to 6 months after receiving I-131 labeled tositumomab.
Exclusion Criteria:
- Patients who have received prior radiolabeled antibody.
- Patients with active hemolysis.
- Patients must not require sustained transfusion support of blood products.
- Patients in 2nd remission or beyond.
- Patients who have undergone treatment with either stem cell or bone marrow transplant.
- Patients with active obstructive hydronephrosis.
- Patients with evidence of any significant systemic illness, active Hepatitis B infection or other active infection at the time of study entry.
- Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation.
- Patients with known HIV infection.
- Patients who are pregnant or nursing.
- Patients with prior malignancy other than CLL/SLL, except for adequately-treated skin cancer (basal cell or squamous cell carcinoma), in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years unless approved by the PI.
- Patients with known brain or leptomeningeal involvement by malignancy.
- Patients who have, in the opinion of the investigator, other medical, social, or psychosocial factors that may negatively impact compliance or their safety by participation in this study.
Last Updated
March 25, 2010See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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