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NCT00054639 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2014-05-28

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients With Objective Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Biological: oblimersen sodium
    2. Biological: rituximab
    3. Other: laboratory biomarker analysis
    label
    Treatment (oblimersen sodium and monoclonal antibody therapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (oblimersen sodium and monoclonal antibody therapy)
    description
    Given IV
    name
    oblimersen sodium
    other Names
    1. augmerosen
    2. G3139
    3. G3139 bcl-2 antisense oligodeoxynucleotide
    4. Genasense
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Treatment (oblimersen sodium and monoclonal antibody therapy)
    description
    Given IV
    name
    rituximab
    other Names
    1. IDEC-C2B8
    2. IDEC-C2B8 monoclonal antibody
    3. Mabthera
    4. MOAB IDEC-C2B8
    5. Rituxan
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Treatment (oblimersen sodium and monoclonal antibody therapy)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
48
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment
    measure
    Number of Patients With Objective Response
    time Frame
    2 months following study treatment
Full study description
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.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice