NCT00054639

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 21, 2011

Completed
Last Updated

May 28, 2014

Status Verified

March 1, 2013

Enrollment Period

7 years

First QC Date

February 5, 2003

Results QC Date

January 24, 2011

Last Update Submit

May 13, 2014

Conditions

Cutaneous B-cell Non-Hodgkin LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueIntraocular LymphomaNodal Marginal Zone B-cell LymphomaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Small Lymphocytic LymphomaSmall Intestine LymphomaSplenic Marginal Zone LymphomaTesticular LymphomaWaldenström Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Treatment (oblimersen sodium and monoclonal antibody therapy)

EXPERIMENTAL

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.

Biological: oblimersen sodiumBiological: rituximabOther: laboratory biomarker analysis

Interventions

oblimersen sodiumBIOLOGICAL

Given IV

Also known as: augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense
Treatment (oblimersen sodium and monoclonal antibody therapy)
rituximabBIOLOGICAL

Given IV

Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
Treatment (oblimersen sodium and monoclonal antibody therapy)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (oblimersen sodium and monoclonal antibody therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Intraocular LymphomaLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-CellWaldenstrom Macroglobulinemia

Interventions

oblimersenRituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsEye NeoplasmsNeoplasms by SiteLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Anas Younes, MD / Professor
Organization
UT MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org

Study Officials

  • Barbara Pro

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

January 1, 2003

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 28, 2014

Results First Posted

February 21, 2011

Record last verified: 2013-03

Locations

US(1)