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

Recurrent Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054639
• Other study ID #: NCI-2011-00617
• Secondary ID: ID02-148N01CM170
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: May 13, 2014
• Start date: January 2003
• Est. completion date: January 2010

Study information

• Verified date: March 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Other known NCT identifiers

• NCT01654952

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Cutaneous B-cell Non-Hodgkin Lymphoma
• Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
• Intraocular Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Large-Cell, Immunoblastic
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Lymphomatoid Granulomatosis
• 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
• Waldenstrom Macroglobulinemia
• Waldenström Macroglobulinemia

Intervention

Biological:
• oblimersen sodium
Given IV
• rituximab
Given IV

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Objective Response	Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment	2 months following study treatment	No