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Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT00054639
Recruitment Status : Completed
First Posted : February 6, 2003
Results First Posted : February 21, 2011
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE February 5, 2003
First Posted Date  ICMJE February 6, 2003
Results First Submitted Date  ICMJE January 24, 2011
Results First Posted Date  ICMJE February 21, 2011
Last Update Posted Date May 28, 2014
Study Start Date  ICMJE January 2003
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2011)
Number of Patients With Objective Response [ Time Frame: 2 months following study treatment ]
Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma
Official Title  ICMJE A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas
Brief Summary The goal of this clinical research study is to learn if the combination of oblimersen sodium and rituximab can help to shrink or slow the growth of the tumor in patients with B-cell non-Hodgkin's lymphoma who have not responded to earlier treatment. Oblimersen Sodium is an investigational drug. The safety of this combination treatment will also be studied
Detailed Description

PRIMARY OBJECTIVES:

I. To determine the therapeutic efficacy and toxicity of G3139 (oblimersen sodium) and Rituximab in patients with recurrent B-cell NHL.

SECONDARY OBJECTIVES:

I. To determine the effect of G3139 and Rituximab on the level of Bcl-2 expression.

II. The secondary objective of this study is to evaluate the effect of G3139 and Rituximab on Bcl-2 protein gene expression.

OUTLINE:

Patients receive oblimersen sodium intravenously (IV) continuously on days 1-7, 15-21, and 29-35 and rituximab IV over 4-6 hours on days 3, 8, 15, 22, 29, and 36. Patients achieving stable disease or objective response may receive one additional course of treatment.

After completion of study treatment, patients are followed up every 3 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Intraocular Lymphoma
  • Nodal Marginal Zone B-cell Lymphoma
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Small Intestine Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Testicular Lymphoma
  • Waldenström Macroglobulinemia
Intervention  ICMJE
  • Biological: oblimersen sodium
    Given IV
    Other Names:
    • augmerosen
    • G3139
    • G3139 bcl-2 antisense oligodeoxynucleotide
    • Genasense
  • Biological: rituximab
    Given IV
    Other Names:
    • IDEC-C2B8
    • IDEC-C2B8 monoclonal antibody
    • Mabthera
    • MOAB IDEC-C2B8
    • Rituxan
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE Experimental: Treatment (oblimersen sodium and monoclonal antibody therapy)
Patients receive oblimersen sodium IV continuously on days 1-7, 15-21, and 29-35 and rituximab IV over 4-6 hours on days 3, 8, 15, 22, 29, and 36. Patients achieving stable disease or objective response may receive one additional course of treatment.
Interventions:
  • Biological: oblimersen sodium
  • Biological: rituximab
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2014)
48
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have recurrent B-cell NHL and measurable disease
  • No anti-lymphoma therapy within the past 4 weeks
  • Must have a good performance status (less than or equal to 2 Zubrod, greater than or equal to 60 Karnofsky)
  • Absolute neutrophil count (ANC) greater than or equal to 1,000
  • Platelets greater than or equal to 75,000
  • Hemoglobin greater than or equal to 10 g/dL
  • Bilirubin less than or equal to 1.5 mg/dL
  • Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvate transaminase (SGPT) less than or equal to 2 times upper limit of laboratory normals
  • Alkaline phosphatase less than or equal to 2 times upper limit of laboratory normals
  • Serum creatinine less than or equal to 1.8 mg/dL
  • Must sign a consent form, and must have a life expectancy of greater than 12 weeks
  • No more than 3 prior chemotherapy regimens
  • Patients who are either Rituximab naive, have previously responded to Rituximab, or are refractory to Rituximab used alone or in combination with chemotherapy

Exclusion Criteria:

  • Human immunodeficiency virus (HIV) positive
  • Active infection or history of opportunistic infections
  • Pregnant women and women of childbearing age who are not practicing adequate contraception; men who are not willing to use an effective method of contraception
  • History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for 5 or more years)
  • Active autoimmune disease
  • Other significant medical diseases
  • Patients with chronic lymphocytic leukemia (CLL)
  • Prior exposure to G3139
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00054639
Other Study ID Numbers  ICMJE NCI-2011-00617
ID02-148
N01CM17003 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
N01CM17107 ( U.S. NIH Grant/Contract )
N01CM62203 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara Pro M.D. Anderson Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP