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LeukemiaPhase 1NCT01035216

A Phase I Study of GNKG168 in Patient With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

A Phase 1 study testing GNKG168 in people with Leukemia, run by SBI Biotech Co., Ltd. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label, dose escalation study designed to characterize the safety, tolerability, efficacy, and pharmacokinetics of GNKG168 in patients with B-CLL that has relapsed or is refractory to all prior standard therapy, or for which no standard therapy exists. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
GNKG168
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
5 sitesUnited States
Study dates
Sep 2009to Nov 2013
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 who have cytologically confirmed B-cell chronic lymphocytic leukemia (B-CLL) that has relapsed or been refractory to all prior standard therapy, or for which no standard therapy exists, or patients who refuse available therapy.
  • Patients' B-CLL must be staged according to either the Rai or Binet systems23 (see Appendix III) and assessed for chromosomal abnormalities, unmutated IgVH status, and expression of ZAP70, and expression of CD38 (see Section 7.2 Pre-treatment).
  • Patients must have recovered from all acute adverse effects of prior therapies to grade 1, excluding alopecia.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Patients must be ≤ to 18 years of age.
  • Patients must have normal organ function as defined by:
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  • total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT)≤ 2.5 x ULN serum creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. The creatinine clearance in male patients may be calculated using the Cockcroft-Gault formula: CrCl (mL/min) = [(140 - age) x weight (kg)]/ 72 x Cr (mg/dL). Note: in female patients, this calculation must be multiplied by a factor of 0.85.
  • Patients must have serum sodium levels ≥ 135 mmol/L and serum chloride levels ≥ 98 mmol/L.
  • Male patients must have a QTc interval of < 450 msec and female patients must have a QTc interval of < 470 msec.
  • Patients must be able to understand and willing to sign a written informed consent document.
  • Patients must be at least 2 weeks from prior chemotherapy, radiation therapy, major surgery, or other investigational anticancer therapy. Patients may receive steroids to control the secondary effects of CLL such as autoimmune cytopenia or painful lymph nodes if this is considered by the treating physician to be in the best interest of the patient.
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Male and female patients must use acceptable contraceptive methods during the entire study period and for 1 month after the end of study or after being discontinued from the study.

Who cannot join

  • Patients who are currently receiving chemotherapy, radiotherapy, biological therapy, or any other investigational therapy.
  • Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse effects due to agents administered more than 4 weeks earlier.
  • Patients with uncontrolled known leukemic meningitis, because of their poor prognosis and likelihood of developing progressive neurologic dysfunction which would confound evaluation of neurologic and other adverse events.
  • Patients with a history of sensitivity or allergy attributed to compounds of similar chemical composition to GNKG168 or to the Prevnar™ vaccine.
  • Patients with concurrent serious infections (i.e., requiring an intravenous antibiotic).
  • Patients with active malignancy (excepting non-melanomatous skin cancers) which may limit survival to less than 2 years.
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  • Patients with pre-existing autoimmune diseases (i.e. systemic lupus erythematosis, rheumatoid arthritis, Crohn's disease or ulcerative colitis, primary sclerosing cholangitis, thyroiditis, scleroderma, etc.) are not eligible.
  • Women who are pregnant or are of childbearing potential and not using methods to avoid pregnancy, and women who are breastfeeding.
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions, history of myocardial infarction within six months of study entry, uncontrolled dysrhythmias or poorly controlled angina.
  • Patients with known positive status for HIV or active hepatitis B or hepatitis C.
  • Patients with any medical condition which in the opinion of the Investigator places them at an unacceptably high risk for toxicities.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Univ. of San Diego: Moores UCSD Cancer Center

    La Jolla, California, 92093

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • North Shore University Hospital

    New Hyde Park, New York, 11042

  • Cornell University

    New York, New York, 10021

  • Oregon Health & Sciences University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Phase I Study of GNKG168 Administered by Intravenous Infusion in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

This is an open-label, dose escalation study designed to characterize the safety, tolerability, efficacy, and pharmacokinetics of GNKG168 in patients with B-CLL that has relapsed or is refractory to all prior standard therapy, or for which no standard therapy exists.

Read the detailed description

This is an open-label, dose escalation study designed to characterize the safety, tolerability, efficacy, and pharmacokinetics of GNKG168 in patients with B-CLL that has relapsed or is refractory to all prior standard therapy, or for which no standard therapy exists.

As secondary objectives, baseline TLR-9 intracellular staining of B-CLL cells, and in vitro assays to assess the potential of B-CLL cells to undergo apoptosis in conjunction with GNKG168 therapy will be examined. Baseline characteristics of B-CLL will be examined including interphase genetics, FISH CLL, IgVH mutational status, expression of ZAP70, β2-microglobulin and the expression of the prognostic marker CD38 in peripheral blood cells (at baseline and during treatment) and baseline immune SNPs (FcγRIIIa, FcγRIIa, TNF-α, IFN-γ, CD40 and others). As pharmacodynamics parameters, the expression of B-cell and T-cell activation markers (including IL-21 receptor upregulation), NK cell markers, and cytokines will be investigated.

This clinical trial will also assess the ability of B CLL patients treated with GNKG168 to elicit anti pneumococcal antibodies in response to adjuvant vaccination with the Prevnar™ vaccine.

Conditions
Leukemia
Being tested
GNKG168
Keywords
Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Medical subject headings
Leukemia, Recurrence, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • GNKG168Drug

    Also called CpG ODN

    GNKG168 will be administered as a 60 minute IV infusion once daily for 5 days followed by a 9 day rest period.

Study groups in NCT01035216
Study groupRoleWhat they receive
GNKG168ExperimentalThe starting dose will be 0.25 mg/kg. If the dose is tolerable, subsequent cohorts will be enrolled and treated with 0.5, 0.75, 1.0 and 1.5 mg/kg. If 0.25 mg/kg proves to be intolerable, the dose will be reduced to 0.15 mg/kg.
Receives: Drug: GNKG168

What is being measured

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

  1. To determine the dose limiting toxicity (DLT) and recommended phase 2 dose

Timeline

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

  1. First posted18 Dec 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionNov 2013
  4. Study completionNov 2013

Why it stopped: This study has been terminated.

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01035216
Sponsor's protocol ID
G07-10075
Status last verified
Sep 2011
First submitted
17 Dec 2009
Last updated
23 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GNKG168 in people with Leukemia, run by SBI Biotech Co., Ltd. at 5 sites 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 12 inclusion and 12 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: stopped early, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

The study was stopped early (reason given: This study has been terminated.). 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?

To determine the dose limiting toxicity (DLT) and recommended phase 2 dose. 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 NCT01035216.

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 23 Dec 2014.

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