NCT00517218

Brief Summary

To compare the efficacy and safety of combination treatment with Genasense, fludarabine, and rituximab versus combination treatment with fludarabine and rituximab in previously untreated subjects with CLL.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2006

Typical duration for phase_3

Status
withdrawn

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

June 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 11, 2008

Status Verified

August 1, 2007

First QC Date

August 14, 2007

Last Update Submit

February 7, 2008

Conditions

Lymphocytic Leukemia

Keywords

Evaluate the Effect of Genasense on the Efficacy/Safety of Rituximab/Fludarabine Treatment in Untreated Subjects With Chronic Lymphocyctic Leukemia

Interventions

Genasense® (, oblimersen sodium G3139)DRUG

Eligibility Criteria

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

You may qualify if:

  • Previously untreated subjects with intermediate-or high-risk CLL(modified Rai Stages I-IV)
  • Measurable disease as primarily established by the National Cancer Institute-sponsored Working Group(NCI-WG) Guidelines for the diagnosis of CLL
  • Requiring therapy for active disease, as primarily defined by the NCI-WG Guidelines
  • Eastern Cooperative Oncology Group Performance Status \< 2
  • Adequate organ function determined , 14 days prior to the first dose of study medication

You may not qualify if:

  • Absolute Lymphocyte count \> 100,000/uL
  • Prior chemotherapy or other therapy for CLL, including allogeneic transplant
  • Less than 3 weeks from any prior major surgery at the time of informed consent
  • Failure to recover from any serious adverse effect of surgery
  • History of autoimmune hemolytic anemia or autoimmune thrombocytopenia
  • Active serious infection requiring systemic anti-infective therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Lymphoid

Interventions

oblimersen

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 16, 2007

Study Start

June 1, 2006

Study Completion

June 1, 2009

Last Updated

February 11, 2008

Record last verified: 2007-08