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

Sponsor

Genta Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT00078234

Collaborator

(none)

Enrollment

Locations

Duration (Months)

8.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: Oblimersen-rituximab-fludarabine	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot Study of Genasense® (G3139, Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia

Study Start Date :

Nov 1, 2003

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2010

Outcome Measures

Primary Outcome Measures

Safety and complete response rate [Monthly for response]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgetown University Medical Center/Lombardi Cancer Center	Washington	District of Columbia	United States	20007
2	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
3	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040