Status:
TERMINATED
DNA Plasmid Encoding a Modified Human Telomerase Reverse Transcriptase (hTERT), Invac-1 in Chronic Lymphocytic Leukemia
Lead Sponsor:
Invectys
Collaborating Sponsors:
M.D. Anderson Cancer Center
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase 2 study to assess the efficacy of INVAC-1, a DNA plasmid encoding a modified human telomerase reverse transcriptas (hTERT) protein, at a dose of 800 µg for 6 cycles 4 weeks apart on Minimal Resi...
Detailed Description
The study will be a phase II, open label, single-arm trial of INVAC-1 at a dose of 800 µg in patients with CLL. The primary goal of the study is to achieve MRD negativity in each group. 42 patients a...
Eligibility Criteria
Inclusion
- Group 1: Untreated high risk "watch and wait"
- Inclusion Criteria:
- Age ≥ 18 years old
- Rai stage 0 - II without active disease according to IWCLL 2018 criteria
- Predicted time to first treatment of ≤3 years according to MDACC nomogram.
- ECOG performance status of 0-2
- Adequate hepatic function, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) \< 2.5 x upper limit of normal (ULN), and total bilirubin ≤ 1.5 x ULN except Gilbert's Syndrome where a direct bilirubin ≤ 1.5 ULN will be used.
- Adequate renal function, defined as an estimated creatinine clearance ≥30 mL/min using the Cockcroft-Gault equation
- Willingness to receive all outpatient treatment, all laboratory monitoring, and all radiological evaluations at the institution that administers study drug for the entire study
- Willingness of male and female patients, if sexually active, to use an effective barrier method of contraception during the study and for 3 months following the last dose of study drug
- Ability to provide written informed consent and to understand and comply with the requirements of the study
- Exclusion Criteria
- Any investigational agent(s) within 4 weeks prior to entry
- Uncontrolled autoimmune hemolytic anemia (Hgb \< 11g/deciliter) or idiopathic thrombocytopenic purpura (\< 100,000/µl)
- Any previous treatment (chemotherapy, radiotherapy, and/or monoclonal antibodies) intended specifically to treat CLL
- Treatment with corticosteroids other than physiological replacement within the previous week or treatment with immunosuppressive medication within the previous week.
- Major surgery within 4 weeks prior to inclusion
- Currently active, clinically significant cardiovascular disease or a history of myocardial infarction within 6 months prior to inclusion
- Uncontrolled active systemic fungal, bacterial, viral, or other infection or requirement for intravenous (IV) antibiotics
- Known history of infection with human immunodeficiency virus (HIV)
- Serologic status reflecting active hepatitis B or C infection.
- History of stroke or intracranial hemorrhage within 6 months prior to enrolment
- Current life-threatening illness, medical condition, or organ-system dysfunction that could compromise patient safety or put the study at risk
- Breast-feeding or pregnant women, or patients for whom there is a risk of conception and who are unable or unwilling to use appropriate contraception (for male and female patients up to 4 months after end of ibrutinib.)
- Previous malignancy with life expectancy less than 6 months or requiring systemic treatment (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
- Known drug abuse/ alcohol abuse
- Severe organ failures or diseases, including: clinically relevant coronary disease, myocardial infarction or any other relevant cardiovascular disorder within 12 months before study entry, severe psychiatric illness and severe infection.
- Group 2: Ibrutinib treated patients
- Inclusion Criteria
- Age ≥ 18 years old
- Males or females with CLL diagnosed according to IWCLL diagnostic criteria who have been treated with ibrutinib therapy for at least 12 months and have had no more than 1 other treatment for CLL prior to receiving ibrutinib.
- Currently in complete or partial remission (PR)/PR with lymphocytosis (PRL)
- MRD positivity defined as \>0.5% CLL cells in the bone marrow by flow cytometry
- ECOG performance status of 0-2
- Adequate hepatic function, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) \< 2.5 x upper limit of normal (ULN), and total bilirubin ≤ 1.5 x ULN, unless Gilbert's Syndrome where a direct bilirubin ≤ 1.5 ULN will be used.
- Adequate renal function, defined as estimated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
- Willingness to receive all outpatient treatment, all laboratory monitoring, and all radiological evaluations at the institution that administers study drug for the entire study
- Willingness of male and female patients, if sexually active, to use an effective barrier method of contraception during the study and for 3 months following the last dose of study drug
- Ability to provide written informed consent and to understand and comply with the requirements of the study
- Exclusion Criteria
- Any investigational agent(s) within 4 weeks prior to entry
- Known involvement of the central nervous system by lymphoma or leukemia
- History or current evidence of Richter's transformation or prolymphocytic leukemia
- Uncontrolled autoimmune hemolytic anemia (Hgb \< 11g/deciliter) or idiopathic thrombocytopenic purpura (\< 100,000/µl)
- More than one previous treatment by chemotherapy or patients who previously received alemtuzumab intended specifically to treat CLL
- Corticosteroid use within 1 week prior to first dose of study drug, with the exception of inhaled, topical, or other local administrations. Patients requiring systemic steroids at daily doses \> 20 mg prednisone (or corticosteroid equivalent), or those who are administered steroids for leukemia control or white blood cell (WBC)-count-lowering are excluded
- Major surgery within 4 weeks prior to inclusion
- Currently active, clinically significant cardiovascular disease or a history of myocardial infarction within 6 months prior to inclusion
- Uncontrolled active systemic fungal, bacterial, viral, or other infection or requirement for intravenous (IV) antibiotics
- Known history of infection with human immunodeficiency virus (HIV)
- Serologic status reflecting active hepatitis B or C infection
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- Current life-threatening illness, medical condition, or organ-system dysfunction that could compromise patient safety or put the study at risk
- Requirement for anticoagulation with warfarin, or for treatment with a strong CYP3A4/5 and/or CYP2D6 inhibitor
- Breast-feeding or pregnant women, or patients for whom there is a risk of conception and who are unable or unwilling to use appropriate contraception (for male and female patients up to 4 months after end of ibrutinib.)
- Previous malignancy with life expectancy less than 6 months or requiring systemic treatment (except colorectal cancer, history of basal cell or squamous carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
- Known drug abuse/ alcohol abuse
- Severe organ failures or diseases, including: clinically relevant coronary disease, myocardial infarction or any other relevant cardiovascular disorder within 12 months before study entry, severe psychiatric illness and severe infection.
Exclusion
Key Trial Info
Start Date :
July 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03265717
Start Date
July 25 2018
End Date
June 30 2020
Last Update
July 8 2020
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030