We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00553202
First Posted: November 5, 2007
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
Results First Submitted: October 31, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Biological: anti-thymocyte globulin
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: methotrexate
Drug: methylprednisolone
Drug: tacrolimus
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Treatment (Chemotherapy and Allogeneic SCT) All patients

Participant Flow:   Overall Study
    Treatment (Chemotherapy and Allogeneic SCT)
STARTED   158 
COMPLETED   90 
NOT COMPLETED   68 
Death                16 
Lost to Follow-up                1 
Physician Decision                28 
Withdrawal by Subject                1 
No donor identified                16 
Fails to meet organ function                6 



  Baseline Characteristics
  Hide 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
Treatment (Chemotherapy and Allogeneic SCT) All Patients

Baseline Measures
   Treatment (Chemotherapy and Allogeneic SCT) 
Overall Participants Analyzed 
[Units: Participants]
 158 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      149  94.3% 
Between 18 and 65 years      9   5.7% 
>=65 years      0   0.0% 
Age 
[Units: Days]
Mean (Standard Deviation)
 3215.34  (2240.48) 
Gender 
[Units: Participants]
Count of Participants
 
Female      75  47.5% 
Male      83  52.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   0.6% 
Asian      4   2.5% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      10   6.3% 
White      128  81.0% 
More than one race      0   0.0% 
Unknown or Not Reported      15   9.5% 
Region of Enrollment 
[Units: Participants]
 
Canada   11 
United States   147 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: At 5 years from HSCT date ]

2.  Primary:   Cumulative Incidence of NK Cell Reconstitution   [ Time Frame: At 5 years from HSCT date ]

3.  Other Pre-specified:   Disease-free Survival   [ Time Frame: From the date of SCT to the date of relapse, the date of death, or the date of last follow-up, whichever occurs first ]

4.  Other Pre-specified:   Acute and Chronic Graft-versus-host Disease   [ Time Frame: Up to 5 years ]

5.  Other Pre-specified:   Time to the Donor-specific NK-cell Receptor Expression   [ Time Frame: Up to 42 days after SCT ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00553202     History of Changes
Other Study ID Numbers: AAML05P1
COG-AAML05P1 ( Other Identifier: Children's Oncology Group )
NCI-2009-00321 ( Registry Identifier: NCI Trial Identifier )
First Submitted: November 2, 2007
First Posted: November 5, 2007
Results First Submitted: October 31, 2016
Results First Posted: February 24, 2017
Last Update Posted: February 24, 2017



To Top