Status:
COMPLETED
UC-961 (Cirmtuzumab) in Relapsed or Refractory Chronic Lymphocytic Leukemia
Lead Sponsor:
Thomas Kipps
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to investigate the safety of the investigational agent, cirmtuzumab. Cirmtuzumab is a monoclonal antibody drug designed to attach to a protein, called ROR1, on the surface ...
Detailed Description
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 cirmtuzumab administere...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Clinical and phenotypic verification of B cell CLL and measurable disease. Immunophenotyping of the leukemic cells must demonstrate a monoclonal B cell population with immunophenotype consistent with CLL.
- Relapsed or refractory disease, defined by failure to achieve a partial response within 6 months of initiation of therapy, or a 50% increase of baseline disease measurements after achieving a clinical response.
- Not amenable to approved therapies.
- Prior Therapy: Must have progressed after purine-analog or alkylator based therapy, or be considered inappropriate for chemo-immunotherapy due to one of the following:
- Del 17p, which is associated with poor response to chemo-immunotherapy, or
- Age greater than 70, or
- Age greater than 65 with one of the following:
- Grade ≥ 3 neutropenia, anemia, or thrombocytopenia attributable to cumulative myelotoxicity from prior administration of cytotoxic agents (as documented by bone marrow biopsy obtained since last prior therapy), or
- Clinically apparent autoimmune cytopenia which may be exacerbated by fludarabine therapy, or
- Estimated creatinine clearance (eCCr) \<70 mL/min (as determined by the Cockcroft-Gault method), or
- Eastern Cooperative Oncology Group (ECOG) performance status greater than 0.
- Has recovered from the toxic effects of prior therapy to their clinical baseline.
- 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 cirmtuzumab.
- Subjects must have at least one of the following indications for treatment:
- Symptomatic or progressive splenomegaly;
- Symptomatic lymph nodes, nodal clusters, or progressive lymphadenopathy;
- Progressive anemia (hemoglobin ≤ 11 g/dL);
- Progressive thrombocytopenia (platelets ≤ 100 x 10\^9/L);
- Weight loss \> 10% body weight over the preceding 6 month period;
- Fatigue attributable to CLL;
- Fever or night sweats for \> 2 weeks without evidence of infection;
- Progressive lymphocytosis with an increase of \> 50% over a 2-month period or an anticipated doubling time of less than 12 months.
- Subjects must have an ECOG performance status of 0-2.
- Adequate hematologic function
- Adequate renal function
- Adequate hepatic function
- Adequate coagulation tests
- EXCLUSION CRITERIA:
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies.
- Patients who are currently receiving another investigational agent are excluded.
- Patients who have had chemotherapy (e.g., purine analogues, alkylating agents), immunotherapy, radiation therapy, or participation in any investigational drug treatment within 4 weeks of initiation of UC-961 or at any time during the study.
- Patients who have had prior (within 8 weeks of initiation of UC-961) or concurrent antibody therapy directed against CLL (i.e., Rituxan® and Campath®).
- Current infection requiring parenteral antibiotics.
- Active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (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 thyroid-stimulating hormone (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, including QTc 481 milliseconds or greater;
- Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
Exclusion
Key Trial Info
Start Date :
August 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02222688
Start Date
August 8 2014
End Date
May 1 2018
Last Update
August 13 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCSD Moores Cancer Center
La Jolla, California, United States, 92093