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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by XEME Biopharma Inc.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
XEME Biopharma Inc.
ClinicalTrials.gov Identifier:
NCT01976520
First received: October 29, 2013
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
Biological: Oncoquest-CLL vaccine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib Trial of Oncoquest-CLL Vaccine for Treatment-Naive Patients With Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by XEME Biopharma Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
    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. [ Time Frame: Up to 15 weeks. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical response evaluated using IWCLL2008 guidelines. [ Time Frame: Up to 1 year. ] [ Designated as safety issue: No ]
    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).

  • In vitro immune response evaluated using T-cell and B-cell immune responses. [ Time Frame: Up to 1 year. ] [ Designated as safety issue: No ]
    T-cell and B-cell responses will be summarized using medians and nonparametric confidence intervals.

  • Progression-free survival. [ Time Frame: Up to 1 year. ] [ Designated as safety issue: No ]
  • Change in absolute lymphocyte count. [ Time Frame: Baseline to up to 1 year. ] [ Designated as safety issue: No ]
  • Change in lymphocyte doubling time. [ Time Frame: Baseline to up to 1 year. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oncoquest-CLL vaccine treatment
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.
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.
Other Name: ATCE Vaccine, ATCEV, Autologous Tumor Vaccine, Oncoquest-CLL

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histologically confirmed B-CLL with low or intermediate risk disease as defined by the modified Rai criteria.
  2. 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.
  3. 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.
  4. Patients must be age 18 years or older
  5. Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Patients must have adequate renal and hepatic function:

    • 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)
  7. 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).
  8. All patients must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

  1. Patients who meet any of the NCI Working Group criteria to initiate treatment for CLL are NOT eligible for participation
  2. Patients who have had or are currently receiving any treatment for CLL, including chemotherapy, corticosteroids, biologic therapy, or immunotherapy are NOT eligible for participation.
  3. 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.
  4. Patients who are receiving cyclosporine, tacrolimus, or other chronic immunosuppressive agents are NOT eligible for participation.
  5. 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.
  6. Although rare, the only exception to this would be patients with Hashimoto's thyroiditis who ARE eligible for participation.
  7. 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.
  8. 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.
  9. 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.
  10. Patients who are pregnant or lactating are NOT eligible for participation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01976520

Contacts
Contact: Shuo Ma, MD, PhD 312-908-5250 Shuo-ma@northwestern.edu

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Study Coordinator    312-695-1301    cancertrials@northwestern.edu   
Principal Investigator: Shuo Ma, MD, PhD         
Sponsors and Collaborators
XEME Biopharma Inc.
Investigators
Principal Investigator: Shuo Ma, MD, PhD Northwestern University
  More Information

No publications provided

Responsible Party: XEME Biopharma Inc.
ClinicalTrials.gov Identifier: NCT01976520     History of Changes
Other Study ID Numbers: NU 13H05, X12-11008, P30CA060553
Study First Received: October 29, 2013
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by XEME Biopharma Inc.:
Cancer vaccine
Chronic lymphocytic leukemia
CLL
Autologous vaccine
B cell leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on September 30, 2014