NCT01976520

Vaccine Therapy for Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: XEME Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Chronic Lymphocytic Leukemia (CLL)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2013-11-05
• Last updated: 2021-04-08

Locations

1 site across 1 country: United States