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Chronic Lymphocytic Leukemia (CLL)Phase 1NCT01976520

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

A Phase 1 study testing Oncoquest-CLL vaccine in people with Chronic Lymphocytic Leukemia (CLL), run by XEME Biopharma Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia (CLL)
What is being tested?
Oncoquest-CLL vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Oct 2013to Jan 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed B-CLL with low or intermediate risk disease as defined by the modified Rai criteria.
  • 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.
  • 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.
  • Patients must have adequate renal and hepatic function:
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  • 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)
  • Females of childbearing potential and sexually active males must consent to use of effective contraception. Child-bearing potential is defined as any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • 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.

Who cannot join

  • Patients who meet any of the NCI Working Group criteria to initiate treatment for CLL are NOT eligible for participation
  • Patients who have had or are currently receiving any treatment for CLL, including chemotherapy, corticosteroids, biologic therapy, or immunotherapy are NOT eligible for participation.
  • Patients who are actively receiving steroids or non-steroidal antiinflammatory drugs (NSAIDs) on a chronic basis and who are unwilling and/or unable to discontinue while on study therapy are NOT eligible for participation. NOTE: Patients must have discontinued steroids or NSAIDs for 1 week prior to registration to be considered eligible for participation.
  • Patients who are receiving cyclosporine, tacrolimus, or other chronic immunosuppressive agents are NOT eligible for participation.
  • Patients who exhibit any active or ongoing autoimmune processes including, but not limited to, autoimmune hemolytic anemia or immune thrombocytopenia purpura, are NOT eligible for participation.
  • Although rare, the only exception to this would be patients with Hashimoto's thyroiditis who ARE eligible for participation.
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  • Patients who demonstrate the presence of antibodies to HIV or hepatitis C or presence of hepatitis B surface antigen or other active infectious process that could suppress the immune system and potentially interfere with the development of an immune response to the tumor antigen are NOT eligible for participation.
  • Patients who have a previous or concomitant malignancy are NOT eligible for participation EXCEPT for the following:
  • Patients with curatively treated squamous or basal cell carcinoma of the skin or effectively treated carcinoma in situ of the cervix ARE eligible for participation.
  • Patient who had a stage 1 solid tumor which has been adequately treated with curative intent, and has been in remission for more than 1 year.
  • Patients with a prior solid tumor who have been in remission more than 5 years ARE eligible for participation.
  • Patients who exhibit any significant concurrent, uncontrolled medical or psychiatric condition that in the opinion of the investigator would compromise the patient's ability to tolerate this treatment are NOT eligible for participation.
  • Patients who are pregnant or lactating are NOT eligible for participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Oncoquest-CLL vaccine
Keywords
Cancer vaccine, Chronic lymphocytic leukemia, CLL, Autologous vaccine, B cell leukemia
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oncoquest-CLL vaccineBiological

    Also called ATCE Vaccine, ATCEV, Autologous Tumor Vaccine, Oncoquest-CLL

    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.

Study groups in NCT01976520
Study groupRoleWhat they receive
Oncoquest-CLL vaccine treatmentExperimentalPatients 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.
Receives: Biological: Oncoquest-CLL vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    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.

    Measured: Up to 30 days post-vaccination

  2. Feasibility in terms of vaccine production.

    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.

    Measured: Up to 4 weeks.

  3. Feasibility in terms of vaccine delivery.

    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.

    Measured: Up to 15 weeks.

Secondary outcomes (5)

  1. Clinical response evaluated using IWCLL2008 guidelines.

    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).

    Measured: Up to 1 year.

  2. In vitro immune response evaluated using T-cell and B-cell immune responses.

    T-cell and B-cell responses will be summarized using medians and nonparametric confidence intervals.

    Measured: Up to 1 year.

  3. Progression-free survival.

    Measured: Up to 1 year.

  4. Change in absolute lymphocyte count.

    Measured: Baseline to up to 1 year.

  5. Change in lymphocyte doubling time.

    Measured: Baseline to up to 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJan 2024 (estimated)
  4. Study completionJan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01976520
Sponsor's protocol ID
NU 13H05
Other IDs
X12-11008, P30CA060553
Status last verified
Apr 2021
First submitted
29 Oct 2013
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oncoquest-CLL vaccine in people with Chronic Lymphocytic Leukemia (CLL), run by XEME Biopharma Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01976520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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