PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00303953

First received: March 15, 2006

Last updated: April 1, 2013

Last verified: April 2013

History of Changes

Results First Received: February 28, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma
Intervention:	Drug: belinostat

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
PXD101	Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.

Participant Flow: Overall Study

	PXD101
STARTED	22
Eligible	21
Eligible and Treated	20
COMPLETED	3
NOT COMPLETED	19
Ineligible	1
Death	1
Adverse Event	4
Lack of Efficacy	12
Physician Decision	1

Baseline Characteristics

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Reporting Groups

	Description
PXD101	Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.

Baseline Measures

	PXD101
Number of Participants [units: participants]	20
Age [units: years] Median ( Full Range )	68.9 ( 51.6 to 82.9 )
Gender [units: participants]
Female	9
Male	11
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	0
Not Hispanic or Latino	19
Unknown or Not Reported	1
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	19
More than one race	0
Unknown or Not Reported	0

Outcome Measures

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1. Primary:

Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: assessed at week 8, and every 3 months for 3 years ]

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2. Secondary:

Overall Survival [ Time Frame: assessed every 3 months for 3 years ]

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3. Secondary:

Progression-free Survival [ Time Frame: assessed at week 8, then every 3 months for 3 years ]

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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
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Results Point of Contact:

Name/Title: Lymphoma Committee Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623
e-mail: mleblanc@fhcrc.org

No publications provided

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00303953 History of Changes
Other Study ID Numbers:	NCI-2009-01096, S0520, CDR0000462614, U10CA032102
Study First Received:	March 15, 2006
Results First Received:	February 28, 2012
Last Updated:	April 1, 2013
Health Authority:	United States: Food and Drug Administration

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