A Phase I Study of GNKG168 in Patient With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
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|ClinicalTrials.gov Identifier: NCT01035216|
Recruitment Status : Terminated (This study has been terminated.)
First Posted : December 18, 2009
Last Update Posted : December 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: GNKG168||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
The 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.
GNKG168 will be administered as a 60 minute IV infusion once daily for 5 days followed by a 9 day rest period.
Other Name: CpG ODN
- To determine the dose limiting toxicity (DLT) and recommended phase 2 dose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035216
|United States, California|
|Univ. of San Diego: Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, New York|
|North Shore University Hospital|
|New Hyde Park, New York, United States, 11042|
|New York, New York, United States, 10021|
|United States, Oregon|
|Oregon Health & Sciences University|
|Portland, Oregon, United States, 97239|