NU 13H05: A Phase Ib Trial of Oncoquest-CLL Vaccine for Treatment-Naive Patients With Chronic Lymphocytic Leukemia

NCT01976520 Phase 1 UNKNOWN

This Phase I trial studies the safety and efficacy of vaccine therapy in treating patients with previously untreated chronic lymphocytic leukemia. Liposome-based vaccines containing an extract of a person's cancer cells and the immunostimulant interleukin-2 may help the body to build an effective immune response to kill cancer cells.

Details

Lead sponsor	XEME Biopharma Inc.
Phase	Phase 1
Status	UNKNOWN
Enrolment	30
Start date	2013-10
Completion	2024-01

Conditions

• Chronic Lymphocytic Leukemia (CLL)

Interventions

• Oncoquest-CLL vaccine

Primary outcomes

• Incidence of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 — Up to 30 days post-vaccination
  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. — Up to 4 weeks.
  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. — Up to 15 weeks.
  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.

Countries

United States