UC-961 (Cirmtuzumab) in Relapsed or Refractory Chronic Lymphocytic Leukemia
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Clinical Trial to Determine the Safety and Tolerability of UC-961 (Cirmtuzumab), an Anti-ROR1 Monoclonal Antibody, for the Treatment of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Who Are Ineligible for Chemotherapy|
- Determine the maximum tolerated dose (MDT) or biologically active dose of Cirmtuzumab [ Time Frame: 1 year ]The MDT is defined as the highest dose studied at which no more than one in six patients experience a DLT.
- Determine the rate of dose limiting toxicities (DLTs) [ Time Frame: within 56 days of starting study treatment ]
|Study Start Date:||August 2014|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
The starting dose is 15 µg/kg. There is intra-patient dose escalation in the first 3 cohorts, followed by the standard 3+3 design for the next 5 cohorts until a maximum tolerated dose (MTD) or biologically active dose is reached. If there is a grade ≥ 2 adverse event in the cohorts with intra-patient dose escalation, the trial will switch to the standard 3+3 design without intra-patient dose escalation for all cohorts.
Other Name: UC-961
This is a first in human, open-label single institution, Phase I dose escalation study of in patients with relapsed or refractory CLL. Treatment cycle (14 days) will consist of UC-961 administered intravenously on a bi-weekly (every two weeks) schedule for a total of 4 doses. Eight dose cohorts (of 3 to 6 patients in size) plus an expansion cohort of 6 patients are planned. In the first 3 dose cohorts, there is intra-patient dose escalation to monitor for acute toxicities, such as tumor lysis syndrome.
A cycle may be repeated every 14 days if the patient has at least stable disease by clinical examination (or interim response assessment) and has again met hematologic, renal, and hepatic laboratory parameters as defined in the eligibility section, and is without ongoing Grade 3 non-hematologic or Grade 4 hematologic toxicities attributable to UC-961. The total duration of study drug administration is 4 cycles. Each cycle consists of clinical and laboratory evaluation on Day 1 and safety assessments on Days 3 and 8.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02222688
|Contact: Jesika Reineremail@example.com|
|United States, California|
|UCSD Moores Cancer Center||Recruiting|
|La Jolla, California, United States, 92093|
|Principal Investigator: Catriona Jamieson, MD, PhD|
|Principal Investigator:||Catriona Jamieson, M.D., Ph.D.||University of California Medical Center|
|Principal Investigator:||Michael Choi, M.D.||University of Calilfornia Medical Center|