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Inhibition of Nuclear Factor Kappa B for Prevention of Disease Progression in Indolent B Cell Malignancies


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia (CLL Enrollment Maximum Has Been Met), Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma

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Trial Information

Inhibition of Nuclear Factor Kappa B for Prevention of Disease Progression in Indolent B Cell Malignancies


Inclusion Criteria:



- Must be over 18 years of age.

- Must be free of other medical conditions that would decrease life expectancy to less
that 12 months.

- Must be free of Omega 3 supplements or other fish oil containing nutritional
supplements for a minimum of two months prior to enrollment.

- Must have a ECOG performance status of 0,1 or 2.

Exclusion Criteria:

- Any life-threatening condition such as (but not limited to) advanced heart disease,
kidney or liver failure with an expected survival of less than 12 months.

- Any other active malignancy.

- Women who are pregnant or lactating.

- Individuals unable to give informed consent.

- Individuals with known allergy or intolerance to fish oil supplements.

- Any patient with an active bleeding diatheses or disorder.

- ECOG performance status of 3 or 4.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine whether consumption of Omega-3 supplement, at the defined dose, can reduce activated Nuclear Factor kappa B in peripheral blood lymphocytes from patients with MGUS and SMM and in malignant lymphocytes from patients with CLL.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Oscar F Ballester, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Marshall University/University Oncology Services at Edwards Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

MU9230

NCT ID:

NCT00899353

Start Date:

August 2008

Completion Date:

July 2012

Related Keywords:

  • Chronic Lymphocytic Leukemia (CLL Enrollment Maximum Has Been Met)
  • Monoclonal Gammopathy of Undetermined Significance
  • Smoldering Multiple Myeloma
  • ES-CLL
  • MGUS
  • SMM
  • Early Stage - Chronic Lymphocytic Leukemia (CLL cohort has been filled)
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Monoclonal Gammopathy of Undetermined Significance
  • Paraproteinemias
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Disease Progression

Name

Location

Edwards Comprehensive Cancer CenterHuntington, West Virginia  25701