ACP-196 in Combination With Obinutuzumab in Relapsed/Refractory or Untreated CLL/SLL/PLL
This trial is active, not recruiting.
|Conditions||chronic lymphocytic leukemia, small lymphocytic lymphoma, prolymphocytic leukemia|
|Treatment||acp-196 in combination with obinutuzumab|
|Sponsor||Acerta Pharma BV|
|Start date||November 2014|
|End date||November 2018|
|Trial size||45 participants|
|Trial identifier||NCT02296918, ACE-CL-003|
This study is evaluating the safety and preliminary efficacy of ACP-196 in combination with obinutuzumab in two separate cohorts of patients.
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
Patients with R/R CLL
Patients with treatment-naïve CLL
The overall response rate (ORR) at 12 months with the combination of ACP-196 + obinutuzumab in patients
time frame: 12 Months
Male or female participants at least 18 years old.
Inclusion Criteria: Patients with a diagnosis of intermediate or high risk CLL (or variant immunophenotype), SLL, or B-PLL by IWCLL 2008 criteria (48) who have: - Previously received at least one therapy for their disease. - Previously untreated disease and 65 years old OR under 65 years old and or refuse or are ineligible for chemoimmunotherapy All patients must satisfy one of the following criteria for active disease requiring therapy: - Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia - Massive (≥ 6 cm below the costal margin), progressive or symptomatic splenomegaly - Massive nodes (≥ 10 cm) or progressive or symptomatic lymphadenopathy - Constitutional symptoms, which include any of the following: - Unintentional weight loss of 10% or more within 6 months - Significant fatigue limiting activity - Fevers ≥100.5 degrees F for 2 weeks or more without evidence of infection - Night sweats >1 month without evidence of infection - Patients with a history of Richter's transformation are eligible if they now have evidence of CLL only, with <10% large cells in the bone marrow. - ECOG performance status ≤ 2 - Life expectancy of < 2 years or that would confound assessment of toxicity in this study - Must be ≥ 18 years of age - Subject must have completed all CLL therapies ≥ 4 weeks prior to first study dose. Exclusion Criteria: - Any life-threatening illness, medical condition, or organ dysfunction which, in the investigator's opinion, could compromise the patients' safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue risk. - Female subjects who are pregnant or breastfeeding. - Subjects with active cardiovascular disease not medically controlled or those who have had myocardial infarction in the past 6 months. - Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction - Major surgery within 4 weeks before first dose of study drug. - History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug. - Subjects with human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) or any uncontrolled active systemic infection - Requires treatment with long-acting proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole)
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