Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT01976520
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2013-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaccine Therapy for Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Sponsor:
XEME Biopharma Inc.
Organization:
Study Overview
Official Title:
NU 13H05: A Phase Ib Trial of Oncoquest-CLL Vaccine for Treatment-Naive Patients With Chronic Lymphocytic Leukemia
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| X12-11008 | OTHER | Theradex | View | |
| P30CA060553 | NIH | None | https://reporter.nih.gov/quic… | View |