Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Constellation Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adults (aged ≥ 18 years)
Histologically confirmed diagnosis of a B-cell lymphoma that has progressed in spite of prior treatment, and for which additional effective standard therapy is not available
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Must give written informed consent to participate in this study before the performance of any study-related procedure
You may not be if
A primary lymphoma of the central nervous system (CNS) or known lymphomatous involvement of the CNS
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CPI-1205, including any unresolved nausea, vomiting, or diarrhea that is CTCAE grade \>1
Treatment with proton pump inhibitors, H2 antagonists, or antacids
Achlorhydria, either documented or suspected on the basis of an associated disease (e.g., pernicious anemia, atrophic gastritis, or certain gastric surgical procedures)
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
Acute myocardial infarction or angina pectoris ≤ 6 months prior to starting study drug
New York Heart Association Class III or IV congestive heart failure
QTcF \> 470 msec on the screening ECG
Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
A past medical history of other clinically significant cardiovascular disease (e.g., uncontrolled hypertension, history of labile hypertension or history of poor compliance with an antihypertensive regimen)
Any other concurrent severe and/or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection)
Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first dose of CPI 1205
Radioimmunotherapy (e.g., 131I-tositumomab, 90Y-ibritumomab tiuxetan) less than 6 weeks before the first dose of CPI-1205
Treatment with an investigational small molecule less than 2 weeks before the first dose of CPI-1205.
Treatment with a therapeutic antibody less than 4 weeks before the first dose of CPI-1205.
Treatment with medications that are strong inhibitors of CYP3A4
Treatment with medications that are inducers of CYP3A4 enzymes
Treatment with medications that are known to carry a risk of Torsades de Pointes
Pregnant or lactating women
Women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
Patients unwilling or unable to comply with this study protocol
Clareo Health | A Study Evaluating CPI-1205 in Patients With B-Cell Lymphomas
