Extension Study of UC-961 (Cirmtuzumab) for Patients With Chronic Lymphocytic Leukemia Treated Previously With UC-961
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|ClinicalTrials.gov Identifier: NCT02860676|
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : March 20, 2019
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The purpose of the study is to investigate the safety of the investigational drug called cirmtuzumab when given for a duration of 6 to 12 months. Cirmtuzumab is a type of drug called a monoclonal antibody. This drug is designed to attach to a protein called ROR1 that is on the surface of chronic lymphocytic leukemia (CLL) cells. This blocks growth and survival of the CLL cells. ROR1 is rarely expressed on healthy cells so this drug should target the cancer cells. Cirmtuzumab is considered experimental because its use is not approved by United States (US) Food and Drug Administration (FDA).
Although there is evidence from tests on laboratory animals that cirmtuzumab can decrease the number of CLL cells, the investigators do not know if this will work in humans. Therefore, the goal of this study is to see if cirmtuzumab is safe and tolerable in study participants when given for a duration of 6 to 12 months.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: cirmtuzumab||Phase 1|
This is an open-label extension study to determine the safety and tolerability of cirmtuzumab given to participants who enrolled and completed the initial phase 1 trial in CLL without a dose-limiting toxicity.
UC-961 is administered by intravenous infusion every 14 days for 4 doses, then every 28 days for 4 doses, after which responses will be assessed. Patients with an objective response (meeting working group criteria for partial response or complete response) will continue at the same dose and schema. Patients with stable disease or progressive disease are eligible to increase the dose of UC-961 for another 6-month course.
Duration of UC-961 administration is until disease progression, treatment intolerance, or lack of clinical benefit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Extension Study to Determine the Safety of UC-961 (Cirmtuzumab) at the Recommended Phase 2 Dose for Retreatment of Patients With Chronic Lymphocytic Leukemia Treated Previously With UC-961|
|Actual Study Start Date :||November 3, 2016|
|Actual Primary Completion Date :||February 27, 2018|
|Actual Study Completion Date :||May 22, 2018|
cirmtuzumab, dose based on ongoing phase 1 trial, q14days x 4 doses, then q28 days x 4 doses, until disease progression.
Other Name: UC-961
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]Adverse events assessed by CTCAE v4.0 during treatment and 3 month follow-up
- Overall response rate [ Time Frame: 1 year ]
- Progression free survival [ Time Frame: 1 year ]
- Stable Disease Rate (SD) [ Time Frame: 1 year ]
- Partial Response Rate (PR) [ Time Frame: 1 year ]
- Minimal Residual Disease Rate (MRD) [ Time Frame: 1 year ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Clinical and phenotypic verification of B cell CLL and measurable disease. Immunophenotyping of the leukemic cells (blood or marrow) must demonstrate a monoclonal (or light chain positive) B cell population with immunophenotype consistent with CLL (e.g., co-expressing CD19 and CD5).
- Recovered from toxic effects attributed to UC-961 to grade 1 levels, or baseline.
Must have measurable disease, including one of the following:
- absolute lymphocyte count greater than 5000/uL
- lymphadenopathy greater than 1.5 cm in longest dimension
- bone marrow biopsy with residual CLL cells, or resultant bone marrow dysfunction
- Women of childbearing potential must agree not to become pregnant for the duration of the study. Both men and women must agree to use a barrier method of contraception for the duration of the study and until 10 weeks after the final dose of UC-961.
- Subjects must have an ECOG performance status of 0-2.
- Adequate hematologic function
- Adequate renal function
- Adequate hepatic function
- Adequate coagulation tests
- Pregnant or breast-feeding women
May have had intervening therapy since completion of initial UC-961 dosing, but excluding the following:
- Within 7 days of UC-961 restart, or 5 half-lives (if known), whichever is shorter: small molecule tyrosine kinase inhibitor (eg: ibrutinib, idelalisib, AVL-292, IPI-145);
- Within 28 days of UC-961 restart: chemotherapy (e.g., purine analogues, alkylating agents), corticosteroids, radiation therapy, or participation in any other investigational drug treatment (besides UC-961);
- Within 56 days of UC-961 restart: previous UC-961 dosing;
- Within 56 days of UC-961 restart: monoclonal antibody therapy directed against CLL (e.g., rituximab, ofatumumab, obinutuzumab, alemtuzumab).
- Current infection requiring parenteral antibiotics.
- Active infection with HIV, HBV, or HCV.
- Concurrent malignancy or prior malignancy within the previous 3 years (other than completely resected carcinoma in situ, prostate cancer, or localized non-melanoma skin cancer).
- Known central nervous system (CNS) involvement by malignancy.
- Untreated autoimmunity such as autoimmune hemolytic anemia, or immune thrombocytopenia.
- Uncompensated hypothyroidism (defined as TSH greater than 2x upper limit of normal not treated with replacement hormone).
- Presence of more than 55% pro-lymphocytes in peripheral blood. Patients with Richter's transformation are not excluded.
- Insufficient recovery from surgical-related trauma or wound healing.
Impaired cardiac function including any of the following:
- Myocardial infarction within 6 months of starting study drug;
- A past medical history of clinically significant ECG abnormalities;
- Other clinically significant heart disease (e.g. uncontrolled congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860676
|United States, California|
|UC San Diego Moores Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Catriona Jamieson, MD, PhD||University of California, San Diego|
|Principal Investigator:||Michael Y Choi, MD||University of California, San Diego|
|Responsible Party:||Catriona Jamieson, Professor of Medicine, University of California, San Diego|
|Other Study ID Numbers:||
|First Posted:||August 9, 2016 Key Record Dates|
|Last Update Posted:||March 20, 2019|
|Last Verified:||March 2019|
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Immune System Diseases