Phase I/II Study of Genasense in Patients With Chronic Ly... | NCT00021749

Studies
Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia

NCT00021749

Sponsor

Genta Incorporated

Status

Completed

Last Update Posted

Nov 13, 2009Estimated

Enrollment

40Actual

Phase

Phase 1Phase 2

Conditions

Chronic Lymphocytic Leukemia
CLL

Interventions

Oblimerson sodium, G3139

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2001

Primary Completion Date

Jan 2003Actual

Completion Date

Not provided

First Submitted Date

Aug 3, 2001

First Submission Date that Met QC Criteria

Aug 4, 2001

First Posted Date

Aug 6, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2009

Last Update Posted Date

Nov 13, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.

Detailed Description

This study is a two-part phase I-II study. Part 1 will determine the MTD of Genasense in patients with CLL. This dose will then be tested in a non-randomized, multi-center, Phase II sequential clinical trial of Genasense used alone for treatment of patients with advanced CLL.

Pharmacokinetics of Genasense and kinetics of Bcl-2 down regulation and re-expression in CLL cells will be followed in selected patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Name	Type	Description	Arm Group Labels	Other Names
Oblimerson sodium, G3139	Drug

Eligibility Module

Eligibility Criteria

Any age
Must have received at least one chemotherapy regimen that included fludarabine
Measurable disease
At least 3 weeks since biological therapy or radiation therapy for chronic lymphocytic leukemia
No previous stem cell transplantation
At least 3 weeks since surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Long Island Jewish Medical Center		New Hyde Park	New York		United States
MD Anderson Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16186597	Result	O'Brien SM, Cunningham CC, Golenkov AK, Turkina AG, Novick SC, Rai KR. Phase I to II multicenter study of oblimersen sodium, a Bcl-2 antisense oligonucleotide, in patients with advanced chronic lymphocytic leukemia. J Clin Oncol. 2005 Oct 20;23(30):7697-702. doi: 10.1200/JCO.2005.02.4364. Epub 2005 Sep 26.

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D007938	Leukemia
D000092122	Bronchiolitis Obliterans Syndrome
D009369	Neoplasms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D009370	Neoplasms by Histologic Type
D006402	Hematologic Diseases