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)

This study has been withdrawn prior to recruitment.

Sponsored by:	Genta Incorporated
Information provided by:	Genta Incorporated
ClinicalTrials.gov Identifier:	NCT00517218

Purpose

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.

Condition	Intervention	Phase
Lymphocytic Leukemia	Drug: Genasense® (, oblimersen sodium G3139)	Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Fludarabine Fludarabine monophosphate Rituximab Oblimersen sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase 3 Study of Fludarabine and Rituximab With or Without Genasense® (Oblimersen Sodium) in Previously Untreated Subjects With Chronic Lymphocytic Leukemia

Further study details as provided by Genta Incorporated:

Study Start Date:	June 2006
Estimated Study Completion Date:	June 2009

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Study ID Numbers:	GL305
Study First Received:	August 14, 2007
Last Updated:	February 7, 2008
ClinicalTrials.gov Identifier:	NCT00517218
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genta Incorporated:

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

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Rituximab

Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Fludarabine
Fludarabine monophosphate
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009