Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia (NCT02677324) | Clinical Trial Compass
CompletedPhase 2
Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia
United States33 participantsStarted 2016-05-09
Plain-language summary
This research study is studying a targeted therapy as a possible treatment for relapsed or refractory Waldenstrom's Macroglobulinemia (WM). This study is using the study intervention ABT-199.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia (Owen 2003; Kyle 2003).
* Measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of \> 2 times the upper limit of normal of each institution is required.
* Have received at least one prior therapy for WM.
* Age ≥ 18 years.
* ECOG performance status \<2 (see Appendix A).
* Participants must have normal organ and marrow function (growth factors cannot be given prophylactically to establish eligibility) as defined below:
* Absolute neutrophil count \> 1,000/mm3
* Platelets \> 50,000/mm3
* Hemoglobin \> 8 g/dL
* Total bilirubin ≤ 1.5 mg/dL or \< 2 mg/dL if attributable to hepatic infiltration by neoplastic disease
* AST (SGOT) and ALT (SGPT) \< 2.5X the institutional upper limit of normal
* Creatinine clearance ≥50 ml/min
* Not on any active therapy for other malignancies with the exception of topical therapies for basal cell or squamous cell cancers of the skin.
* Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or have or will have complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) while participating in the study; and 2) for at least 28 days after discontinuation from the study. Me…