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Trial record 11 of 554 for:    Thrombocytopenia: Clinical Trials

A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma

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ClinicalTrials.gov Identifier: NCT00283439
Recruitment Status : Completed
First Posted : January 30, 2006
Results First Posted : September 13, 2010
Last Update Posted : June 20, 2011
Sponsor:
Information provided by:
Amgen

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Chemotherapy-Induced Thrombocytopenia
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Cancer
Oncology
Thrombocytopenia
Intervention: Biological: AMG 531

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 15 March 2006 through 28 April 2008

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
Romiplostim 100 µg Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 300 µg Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 700 µg Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 1000 µg Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy

Participant Flow:   Overall Study
    Romiplostim 100 µg   Romiplostim 300 µg   Romiplostim 700 µg   Romiplostim 1000 µg
STARTED   8   11   11   9 
COMPLETED   0   0   0   0 
NOT COMPLETED   8   11   11   9 
Adverse Event                0                0                0                1 
Death                0                0                1                0 
Disease progression                0                1                0                0 
Requirement for alternative therapy                1                2                5                2 
Stem cell transplant                6                6                4                3 
Treatment discontinued                0                2                1                3 
Not specified                1                0                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Romiplostim 100 µg Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 300 µg Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 700 µg Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
Romiplostim 1000 µg Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
Total Total of all reporting groups

Baseline Measures
   Romiplostim 100 µg   Romiplostim 300 µg   Romiplostim 700 µg   Romiplostim 1000 µg   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   11   11   9   39 
Age 
[Units: Year]
Mean (Standard Deviation)
 61.3  (6.2)   58.1  (9.5)   54.0  (16.3)   59.9  (10.6)   58.0  (11.5) 
Gender 
[Units: Participant]
         
Female   3   3   4   5   15 
Male   5   8   7   4   24 
Race/Ethnicity, Customized 
[Units: Participant]
         
White or Caucasian   6   10   10   8   34 
Black or African American   0   0   1   1   2 
Hispanic or Latino   2   1   0   0   3 


  Outcome Measures

1.  Primary:   Change in Platelet Nadir   [ Time Frame: 32 weeks ]

2.  Secondary:   Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia   [ Time Frame: 32 weeks ]

3.  Secondary:   Duration of Grade 3 or 4 Thrombocytopenia   [ Time Frame: 32 weeks ]

4.  Secondary:   Percentage of Subjects That Received Platelet Transfusions   [ Time Frame: 32 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436



Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00283439     History of Changes
Other Study ID Numbers: 20050144
First Submitted: January 26, 2006
First Posted: January 30, 2006
Results First Submitted: August 13, 2010
Results First Posted: September 13, 2010
Last Update Posted: June 20, 2011