A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Mac… (NCT03225716) | Clinical Trial Compass
TerminatedPhase 1
A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia
Stopped: Sponsor decision to end follow-up early
United States13 participantsStarted 2017-10-20
Plain-language summary
This research study is studying Ulocuplumab combined with ibrutinib as a possible treatment for symptomatic Waldenstrom's Macroglobulinemia (WM).
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 (Kyle et al, 2003) or have high risk disease with an serum IgM level of 6,000 mg or higher (Gustine et al, 2016).
* MYD88 and CXCR4 mutated disease (determined by Treon laboratory or molecular diagnostics laboratory).
* 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.
* Age ≥ 18 years
* ECOG performance status \< or = 2 (see Appendix A.).
* To establish eligibility, participants must have adequate organ and marrow function as defined below:
* Absolute neutrophil count ≥ 1,000/uL
* Platelets ≥ 75,000/uL
* Hemoglobin ≥ 8 g/dL
* Total bilirubin ≤ 1.5 mg/dL or \< 2 mg/dL if attributable to hepatic infiltration by neoplastic disease or Gilbert's syndrome
* AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal
* Creatinine ≤ 2 mg/dL
* 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…