Oncoquest-CLL vaccine for Leukemia, Lymphoid

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, IL
Leukemia, Lymphoid+3 More
Oncoquest-CLL vaccine - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a vaccine can be used to treat people with chronic lymphocytic leukemia.

See full description

Eligible Conditions

  • Leukemia, Lymphoid
  • Chronic Lymphocytic Leukemia (CLL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia, Lymphoid

Study Objectives

This trial is evaluating whether Oncoquest-CLL vaccine will improve 3 primary outcomes and 5 secondary outcomes in patients with Leukemia, Lymphoid. Measurement will happen over the course of Up to 4 weeks..

Year 1
Change in absolute lymphocyte count.
Change in lymphocyte doubling time.
Up to 1 year.
Clinical response evaluated using IWCLL2008 guidelines.
In vitro immune response evaluated using T-cell and B-cell immune responses.
Progression-free survival.
Up to 15 weeks.
Feasibility in terms of vaccine delivery.
Day 30
Incidence of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Up to 4 weeks.
Feasibility in terms of vaccine production.

Trial Safety

Safety Progress

1 of 3

Other trials for Leukemia, Lymphoid

Trial Design

1 Treatment Group

Oncoquest-CLL vaccine treatment
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Oncoquest-CLL Vaccine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Oncoquest-CLL vaccine treatment
Biological
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 1 year. for reporting.

Closest Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Leukemia, Lymphoid or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have lymphocytosis with white blood cells between 30,000-100,000/microliters (uL) in order to collect adequate leukemia cells for vaccine production.
Has not undergone a hysterectomy or bilateral oophorectomy; OR Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding consecutive 12 months).
All patients must have given signed, informed consent prior to registration on study.
Patients must have histologically confirmed B-CLL with low or intermediate risk disease as defined by the modified Rai criteria.
Patients must have evidence of disease progression as demonstrated by an increase of more than 50% in lymphocytosis since diagnosis and/or lymphadenopathy and a lymphocyte doubling time of more than 6 months. Patients must have had at least 3 months of observation since diagnosis.
Patients must be age 18 years or older
Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Serum creatinine less than or equal to 2.0 mg/deciliter (dL)
Total Bilirubin less than or equal to 2.0 mg/dL
Serum glutamic-oxaloacetic transaminase/serum glutamate pyruvate transaminase (SGOT/SGPT) less than or equal to 2.5 x upper limit of normal (ULN)

Patient Q&A Section

Can leukemia, lymphocytic, chronic, b-cell be cured?

"Today's chemotherapy regimens have improved tremendously. In modern medical practice, a cure of leukemia is not achievable. A cure does not exist among chronic lymphocytic leukemia patients. Leukemia, lymphocytic, chronic, b-cell is not curable. The current treatment options are only palliative." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia, lymphocytic, chronic, b-cell?

"A number of treatments for leukemia, lymphocytic, and related conditions have been developed and are used and many of these are still under study with a goal to identify those most effective and to help select less toxicity. The list of treatments for these diseases is growing and will be expanding with improved understanding of the disease process and treatment regimens. This article illustrates the treatments used to treat some cancers, while other articles in this section go into the pathology of the diseases, and treatments used. The most common treatments are summarized in Table 1." - Anonymous Online Contributor

Unverified Answer

How many people get leukemia, lymphocytic, chronic, b-cell a year in the United States?

"Approximately 40,000 people are diagnosed with [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia) each year. Around 3,000 people are diagnosed with acute myeloid (leukemia) each year, and 5,000 with acute lymphocytic (chronic lymphocytic) leukemia." - Anonymous Online Contributor

Unverified Answer

What causes leukemia, lymphocytic, chronic, b-cell?

"Most cases involve defects in the immune system, and are most likely to occur after a person has been exposed to certain environmental hazards, or heredity." - Anonymous Online Contributor

Unverified Answer

What is leukemia, lymphocytic, chronic, b-cell?

"Leukemia, lymphocytic, chronic, b-cell, a blood or bone marrow cancer is the most common cancer among patients with SLE. However, since other hematologic and oncologic diseases can present with the same symptoms as and have a similar course to SLE, it often goes unrecognized or undiagnosed." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia, lymphocytic, chronic, b-cell?

"Signs of leukemia include an enlarged spleen in 30% of cases, a low platelet count in 15% of cases, and elevated red blood cell count. Signs of lymphocytic leukemia include a high lymphocyte count in 15% (20% of cases), a decreased red cell count in 3% (20% of cases), and a low platelet count in 3% (10% of cases)." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of leukemia, lymphocytic, chronic, b-cell?

"Many patients with [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia) develop secondary primary chronic myelogenous leukemia due to an error during hematopoietic stem cell transplantation as a result of primary chronic myelogenous leukemia. Lymphoid leukemia, chronic lymphocytic, B-cell, and chronic myelogenous are classified into one syndrome. The diagnosis may not be made until lymphoid or myeloid leukemia develops years after transplantation. These patients present with the new syndrome as well. Primary chronic myelogenous leukemia often follows one of the secondary cancers, i.e., lymphoid or myeloid." - Anonymous Online Contributor

Unverified Answer

How quickly does leukemia, lymphocytic, chronic, b-cell spread?

"This is probably the fastest leukemia I have seen in some years, but I have not yet been able to measure this in detail due to delays in the processing of blood samples. Also, as this was a single patient, I cannot be sure how representative the results are (this is more likely in a real clinical setting). However, based on past reports, it probably translates into a median time of 24 to 73 days. Lymphocytic, chronic, b-cell spread occurs within the first 7 days of diagnosis in this case. Patients with a history of chemotherapy were more likely to die from leukemia, lymphocytic, chronic, b-cell cancer than patients with a history of leukemia without chemotherapy." - Anonymous Online Contributor

Unverified Answer

What is the latest research for leukemia, lymphocytic, chronic, b-cell?

"In recent months the use of bortezomib in combination with other chemotherapies has gained significant interest as a treatment for B-cell malignancies, particularly low-risk diffuse large B-cell lymphomas. The addition of bortezomib plus mitoxantrone is also a novel treatment approach for low-risk, unfavorable indolent follicular lymphomas. Trials with this combination will continue into 2019." - Anonymous Online Contributor

Unverified Answer

Is oncoquest-cll vaccine safe for people?

"Individuals previously treated with B-cell depletion therapies are more frequently vaccinated with OVCLL than previously diagnosed participants. However, the vaccine was not associated with any allergic reactions or serious side effects." - Anonymous Online Contributor

Unverified Answer

Is oncoquest-cll vaccine typically used in combination with any other treatments?

"The treatment of refractory/relapsed/sensitive CLL patients with oncoquest-cll and/or chemotherapy resulted mainly in stable disease rates comparable to chemotherapy. However, the combined therapy with oncoquest-cll and bortezomib resulted in prolonged progression-free survival rates similar to other studies and the single-agent-oncoquest regimen." - Anonymous Online Contributor

Unverified Answer

Does oncoquest-cll vaccine improve quality of life for those with leukemia, lymphocytic, chronic, b-cell?

"OC-CLL is well tolerated and is associated with significant improvement in QOL among patients with lymphocytic cancers. These data provide an exciting rationale for a broader trial of OC-CLL in a more heterogeneous patient population." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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