Vaccine Therapy for Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Chronic Lymphocytic Leukemia (CLL)
Biological: Oncoquest-CLL vaccine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||NU 13H05: A Phase Ib Trial of Oncoquest-CLL Vaccine for Treatment-Naive Patients With Chronic Lymphocytic Leukemia|
- Incidence of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 30 days post-vaccination ] [ Designated as safety issue: Yes ]Safety data will be tabulated for all patients and include vital signs, laboratory parameters, and adverse events. Toxicities will be summarized descriptively by type and attribution.
- Feasibility in terms of vaccine production. [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]The rate of successful production of the vaccine will be calculated. Successful production (feasibility) will be dichotomous. Dichotomous outcomes will be summarized using proportions and exact 95% binomial confidence intervals.
- Feasibility in terms of vaccine delivery. [ Time Frame: Up to 15 weeks. ] [ Designated as safety issue: No ]The rate of successful delivery of the vaccine will be calculated. Successful delivery (feasibility) will be dichotomous. Dichotomous outcomes will be summarized using proportions and exact 95% binomial confidence intervals.
- Clinical response evaluated using IWCLL2008 guidelines. [ Time Frame: Up to 1 year. ] [ Designated as safety issue: No ]Clinical response to vaccination will be evaluated by parameters of reduction in leukemia cell count, lymph node size, liver and spleen size, and reduction in amount of disease in bone marrow) and improved hematologic parameters (including hemoglobin and platelet count).
- In vitro immune response evaluated using T-cell and B-cell immune responses. [ Time Frame: Up to 1 year. ] [ Designated as safety issue: No ]T-cell and B-cell responses will be summarized using medians and nonparametric confidence intervals.
- Progression-free survival. [ Time Frame: Up to 1 year. ] [ Designated as safety issue: No ]
- Change in absolute lymphocyte count. [ Time Frame: Baseline to up to 1 year. ] [ Designated as safety issue: No ]
- Change in lymphocyte doubling time. [ Time Frame: Baseline to up to 1 year. ] [ Designated as safety issue: No ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Oncoquest-CLL vaccine treatment
Patients receive Oncoquest-CLL vaccine subcutaneously on Day 1 and 15, and then monthly for 3 months in the absence of disease progression or unacceptable toxicity.
Biological: Oncoquest-CLL vaccine
Comparison of 4 different dose levels of Oncoquest-CLL vaccine: 100 micrograms (mcg)/0.2 milliliters (mL), 200 mcg/0.4 mL, 375 mcg/0.75 mL, and 500 mcg/mL. Patients will receive a total of 5 doses of vaccines; the first 2 doses separated by 2 week intervals and the last 3 doses by 1 month intervals. Vaccine will be given by sc injections in 2 sites in upper arms or legs.
Other Name: ATCE Vaccine, ATCEV, Autologous Tumor Vaccine, Oncoquest-CLL
I. To evaluate the safety of vaccination with Oncoquest-Chronic Lymphocytic Leukemia (CLL) vaccine (autologous tumor cell extract vaccine).
II. To evaluate the feasibility of Oncoquest-CLL production and administration to previously untreated patients with CLL.
I. To evaluate the clinical response [as defined by the International Workshop on Chronic Lymphocytic Leukemia 2008 (iwCLL2008)] of the Oncoquest-CLL vaccine in treatment-naive patients with CLL.
II. To evaluate the T and B cell immune responses against autologous leukemia cells induced with Oncoquest-CLL vaccine.
III. To measure the progression-free survival of patients treated with the Oncoquest-CLL vaccine.
IV. To evaluate the change in absolute lymphocyte count and lymphocyte doubling time before and after vaccine administration and correlate this with immune response.
Patients receive autologous tumor vaccine subcutaneously (SC) on Study Day 1 and 15, and then monthly for 3 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 3 months, and then every 3 months for up to 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01976520
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Shuo Ma, MD, PhD||Northwestern University|