Genasense® (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects With Chronic Lymphocytic Leukemia

NCT00078234 | Completed Phase 1

• 1 other identifier: GL217
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

The treatment combination of Rituxan® (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, some leukemia subjects continue to have leukemia despite treatment with these standard anticancer drug therapies, or they may work for only a short period of time. In some subjects, when the leukemia does not respond well to therapy the leukemia cells may be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a protein that appears to protect cancer cells from being killed and thus lengthens the life of the cancer cells. Genasense® (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may work more effectively as a cancer treatment. Genasense® may also directly kill CLL cells. This study will test whether treating subjects with Genasense®, fludarabine and rituximab is safe and effective.

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL; Leukemia; Chronic; Cancer; Adult; Lymphocytic; Genasense; G3139; Genta; Bcl-2; Antisense; Oligonucleotide; oblimersen

Outcome Measures

Primary Outcomes (1)

• Safety and complete response rate

  Monthly for response

Interventions

Oblimersen-rituximab-fludarabine DRUG

28-day cycles; Cycle 1: oblimersen by continuous IV infusion 1.5 mg/kg/d for 7 consecutive days, completing on Day 8; rituximab by IV infusion on Day 4 (125 mg/m2) and Day 6 (250 mg/m2); fludarabine 25 mg/m2 by IV infusion for 3 days, starting on Day 6. Subsequent cycles: oblimersen 3 mg/kg/d, completing on Day 8; rituximab 375 mg/m2 on Day 5; fludarabine 25 mg/m2 for 3 days starting the same day as rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Absolute lymphocyte count of \> 10,000 cells/mm3 or history of ALC \>10,000 cell/mm3
• Platelets \> 50,000 cells/mm3
• Tumor lymphocytes expressing surface CD5, CD19, CD20 and CD23
• Creatinine \< 1.5 mg.dL

You may not qualify if:

• Less than 3 weeks from any prior major surgery or other therapy for CLL including radiation therapy, chemotherapy, high-dose steroid therapy, immunotherapy, cytokine, biologic or vaccine therapy.
• History of autoimmune hemolytic anemia
• Prior allogeneic transplant

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (3)

Georgetown University Medical Center/Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia; Bronchiolitis Obliterans Syndrome; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2004
• First Posted: February 23, 2004
• Study Start: November 1, 2003
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2010
• Last Updated: November 7, 2011

Record last verified: 2009-05

Locations

US (3)