Study of ONTAK in Patients With B-Cell Chronic Lymphocyti... | NCT00055146

Studies
Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)

NCT00055146

Sponsor

Eisai Inc.

Status

Completed

Last Update Posted

Apr 17, 2009Estimated

Enrollment

41Estimated

Phase

Phase 2

Conditions

Leukemia, Lymphocytic, Chronic

Interventions

ONTAK

Countries

United States
Argentina
Australia
Brazil
Canada

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

Apr 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

Mar 2003

Primary Completion Date

Mar 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Feb 19, 2003

First Submission Date that Met QC Criteria

Feb 20, 2003

First Posted Date

Feb 21, 2003Estimated

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

Apr 16, 2009

Last Update Posted Date

Apr 17, 2009Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Estimated

Name	Type	Description	Arm Group Labels	Other Names
ONTAK	Drug

Measure	Description	Time Frame
Objective Clinical Response

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with B-cell Chronic Lymphocytic Leukemia, Rai Stage 0-II with indication for treatment by NCI Working Group Criteria or Rai Stage III or IV.
Patients must have received at least one prior purine analogue-based chemotherapy regimen.
ECOG Performance Status of 0, 1, or 2.
Female patients cannot be pregnant and must use birth control during the course of the study and for three weeks after the study ends.

Exclusion Criteria:

Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2.
Received any therapy for CLL within 35 days prior to study entry.

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

Name	Affiliation	Role
Elyane Lombardy, M.D.	Ligand Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pacific Coast Hematology/Oncology Medical Group, Inc.		Fountain Valley	California	92708	United States

Condition Browse Module

MeSH Terms

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell

Ancestor Terms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C078456	denileukin diftitox

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided