Phase II Study of ONTAK in Previously Treated Patients With Low-grade Non-Hodgkin's Lymphoma (NHL)

This study has been completed.

Study NCT00051025 Information provided by Eisai Inc.

First Received on December 31, 2002. Last Updated on July 7, 2011 History of Changes

Results First Received: July 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Conditions:	Non-Hodgkin's Lymphoma Lymphoma, B-cell Lymphoma, Low-grade
Intervention:	Drug: ONTAK

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was recruited at 6 centers in U.S. during the period of 18-May-2000 to 12-May-2001

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Ontak 4-Course Group	Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
Ontak 8-Course Group	Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days

Participant Flow: Overall Study

	Ontak 4-Course Group	Ontak 8-Course Group
STARTED	5	4
COMPLETED	3	0
NOT COMPLETED	2	4
Progressive Disease	1	1
Adverse Event	1	1
Withdrawal by Subject	0	1
Death	0	1

Baseline Characteristics

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Reporting Groups

	Description
Ontak 4-Course Group	Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
Ontak 8-Course Group	Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days

Baseline Measures

	Ontak 4-Course Group	Ontak 8-Course Group	Total
Number of Participants [units: participants]	5	4	9
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	3	2	5
>=65 years	2	2	4
Age [units: years] Mean ± Standard Deviation	65.4 ± 8.4	60.8 ± 15.5	63.3 ± 11.5
Gender [units: participants]
Female	3	1	4
Male	2	3	5
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	1	1
White	5	3	8
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Region of Enrollment [units: participants]
United States	5	4	9

Outcome Measures

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1. Primary:

Objective Clinical Response (CR or PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8. [ Time Frame: 24 Weeks ]

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2. Secondary:

Duration of Response [ Time Frame: From beginning of response to time of relapse ]

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3. Secondary:

Time-to-Treatment Failure [ Time Frame: From start of first treatment ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Not Specified

Results Point of Contact:

Name/Title: Eisai Inc
Organization: Eisai Call Center
phone: 888-422-4743

No publications provided

ClinicalTrials.gov Identifier:	NCT00051025 History of Changes
Obsolete Identifiers:	NCT00005621
Other Study ID Numbers:	L4389-30
Study First Received:	December 31, 2002
Results First Received:	July 7, 2011
Last Updated:	July 7, 2011
Health Authority:	United States: Food and Drug Administration