This Study is Being Performed to Evaluate the Effect of Genasense on the Efficacy and the Safety of Rituximab/Fludarabine Combination Treatment in Previously Untreated Subjects With Chronic Lymphocyctic Leukemia(CLL)

A Randomized Phase 3 Study of Fludarabine and Rituximab With or Without Genasense® (Oblimersen Sodium) in Previously Untreated Subjects With Chronic Lymphocytic Leukemia

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00517218

Enrollment

Unknown

Registered

2007-08-16

Start date

2006-06-30

Completion date

2009-06-30

Last updated

2008-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphocytic Leukemia

Keywords

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

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.

Interventions

DRUGGenasense® (, oblimersen sodium G3139)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026