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A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Rituximab in Subjects With CD20-positive Lymphoid Malignancies

This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with rituximab in subjects with CD20-positive lymphoproliferative disorders. The extension portion of the study will allow active subjects to continue to receive ABT-263 for up to 7 years after the last subject transitions with quarterly study evaluations.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : rituximab
  • drug : ABT-263

Phase: Phase 1

Eligibility

Ages Eligible For Study:

18 Years - 99 Years

Inclusion Criteria

- Diagnosed with a CD20-positive lymphoproliferative disorder (REAL/WHO) and bi-dimensionally measurable disease with at least 1 lesion > or = 1.0 cm - ECOG performance score of <or = 1 - Adequate bone marrow function, independent of growth factor support (with the exception of subjects with bone marrow that is heavily infiltrated with underlying disease [80% or more] who may use growth factor to achieve ANC eligibility criteria) per local laboratory reference range as follows: Absolute Neutrophil count (ANC) ? 1000/?L; Platelets ? 100,000/mm3 (untransfused); Hemoglobin ? 9.0 g/dL. - Subjects who have a history of autologous stem cell transplant (e.g., bone marrow) must be > 6 months post transplant and have adequate bone marrow function, independent of any growth stimulating factors (with the exception of subjects with bone marrow that is heavily infiltrated with underlying disease [80% or more] who may use growth factor to achieve ANC eligibility criteria) per local laboratory reference range as follows: Absolute Neutrophil count (ANC) ? 1500/?L; Platelets ? 125,000/mm3 (untransfused); Hemoglobin ? 10.0 g/dL. - Subject must have adequate renal, hepatic and coagulation function per local laboratory reference range as follows: Serum creatinine ? 2.0 mg/dL or calculated creatinine clearance ? 50 mL/min; AST and ALT ? 3.0 the upper normal limit (ULN); Bilirubin ? 1.5 ULN. Subjects with Gilbert's Syndrome may have a Bilirubin > 1.5 ULN; aPTT, PT not to exceed 1.2 ULN - Females must be surgically sterile, postmenopausal (at least 1 year), or have negative pregnancy test at screening on serum sample and prior to first dose of study drug on urine sample. Females not surgically sterile or postmenopausal (at least 1 year) and non-vasectomized males must practice at least 1 of the following:total abstinence from sexual intercourse (min.1 complete menstrual cycle),a vasectomized partner, hormonal contraceptives for at least 3 months prior to study drug administration, or double-barrier method. - Inclusion Criteria (Extension Study) Subjects who enter the Extension Study must continue to meet all Inclusion and Exclusion criteria, with the exception of inclusion criteria regarding measurable disease and inclusion criteria regarding laboratory parameters. Subjects entering the Extension Study must also have stable lab values per local laboratory reference ranges. In addition they must meet the following lab criteria: - Subjects must meet the following hematology and coagulation lab criteria: - Platelet counts must be ? 25,000/mm3 (untransfused). Platelet counts ? 50,000/mm3 must be stable and monitored at an increased frequency at the discretion of the investigator. - Absolute Neutrophil count (ANC) ? 500/?L. ANC ? 500/?L and < 1,000/?L should be monitored at an increased frequency at the discretion of the investigator. - Hemoglobin of ? 8.0 g/dL. - aPTT, PT is not to exceed 1.2 ULN. - Subjects' chemistry values must not exceed Grade 2. Grade 2 chemistry labs should be monitored at an increased frequency at the discretion of the investigator. Subjects must meet the following chemistry criteria: - Serum creatinine ? 3.0 the upper normal limit (ULN) of institution's normal range. - AST and ALT ? 5.0 the upper normal limit (ULN) of institution's normal range. - Bilirubin ? 3 ULN. Subjects with Gilbert's Syndrome may be allowed to have a Bilirubin > 3 ULN based on a joint decision between the investigator and Abbott medical monitor.

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting

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