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A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas


Phase 2
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Patients With Objective Response

Outcome Description:

Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment

Outcome Time Frame:

2 months following study treatment

Safety Issue:

No

Principal Investigator

Barbara Pro

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-00617

NCT ID:

NCT00054639

Start Date:

January 2003

Completion Date:

Related Keywords:

  • 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
  • Burkitt Lymphoma
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Mantle-Cell

Name

Location
M D Anderson Cancer Center Houston, Texas  77030