1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transpla… (NCT03133221) | Clinical Trial Compass
CompletedPhase 2
1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation
United States17 participantsStarted 2017-10-23
Plain-language summary
This is a pilot study to learn how safe and how effective the study drug Zydelig works, after autologous stem cell transplant as a maintenance therapy in patients with indolent or transformed indolent B-cell non-Hodgkins lymphoma (iNHL or tiNHL).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically documented (by HPI or pathology report) iNHL as defined by follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma/Waldenstrom disease (LPL/WM) and small lymphocytic lymphoma (SLL) or tiNHL as defined by large B cell transformation of any of the above entities including chronic lymphocytic leukemia (CLL)
✓. Patients must be eligible to undergo high dose chemotherapy (HDT) followed by ASCT as a form of remission consolidation
✓. Patients without evidence of documented disease progression clinically or radiographically after ASCT (stable disease (SD), partial remission (PR) or complete remission (CR)) who have had count recovery (ANC \> 500, non-transfused platelet count \> 20,000) and are at least 30 days post ASCT but no more than 120 days post ASCT
✓. Patients may have received any prior therapy deemed necessary for them to be eligible to HDT/ASCT except for patients whom have progressed while on Zydelig. Patients who have responded to Zydelig previously are eligible for enrollment on the protocol.
✓. Age \>18
✓. ECOG performance status \<4
✓. Life expectancy of greater than four months.
✓. Patients must have normal organ function as defined below (after the HDT/ASCT):
Exclusion criteria
✕. Patients who have had chemotherapy or radiotherapy within 2 weeks of first dose of Zydelig.
✕. Patients receiving any other investigational agents within 30 days of receiving Zydelig
What they're measuring
1
Discontinuation Rate Due to Zydelig-related Adverse Events at 1 Year
✕. Patients who were previously exposed to Zydelig and experienced progression of disease.
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Zydelig.
✕. Patients with active and/or untreated CNS lymphoma will not be eligible.
✕. Patients with inflammatory bowel disease.
✕. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection (defined as requiring systemic antibiotic treatment and fever within 48 hours of screening), symptomatic congestive heart failure (patients with NYHA score of III and above are excluded), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
✕. Women who are pregnant or nursing or plan to become pregnant or nurse during the course of the study.