Overview

This trial is active, not recruiting.

Conditions chronic lymphocytic leukemia, small lymphocytic lymphoma, prolymphocytic leukemia
Treatments acalabrutinib in combination with obinutuzumab
Phase phase 1
Targets BTK, CD20
Sponsor Acerta Pharma BV
Start date November 2014
End date November 2018
Trial size 45 participants
Trial identifier NCT02296918, ACE-CL-003

Summary

To evaluate the safety and preliminary efficacy of acalabrutinib in combination with obinutuzumab in 2 separate cohorts of patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients with R/R CLL
acalabrutinib in combination with obinutuzumab ACP-196
Patients with R/R CLL
acalabrutinib in combination with obinutuzumab ACP-196
Patients with treatment-naive CLL
(Experimental)
Patients with treatment-naïve CLL
acalabrutinib in combination with obinutuzumab ACP-196
Patients with R/R CLL
acalabrutinib in combination with obinutuzumab ACP-196
Patients with treatment-naive CLL

Primary Outcomes

Measure
The overall response rate (ORR) at 12 months with the combination of acalabrutinib + obinutuzumab in patients
time frame: 12 Months

Eligibility Criteria

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 acalabrutinib, 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)

Additional Information

Official title A Phase 1b Study of ACP-196 in Combination With Obinutuzumab for Patients With Relapsed / Refractory or Untreated CLL/SLL/PLL
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Acerta Pharma BV.