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Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer

This study has been terminated.
(terminated early due to meeting end point with fewer patients than anticipated)
Sponsor:
Collaborator:
Blood and Marrow Transplant Group of Georgia
Information provided by (Responsible Party):
Northside Hospital, Inc.
ClinicalTrials.gov Identifier:
NCT00818961
First received: January 7, 2009
Last updated: October 28, 2013
Last verified: October 2013
Results First Received: March 22, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Interventions: Biological: alemtuzumab
Biological: graft-versus-tumor induction therapy
Biological: rituximab
Drug: busulfan
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methotrexate
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation

  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
The first patient on this study was enrolled & transplanted on 6/9/05. The last patient on this study was enrolled & transplanted on 1/5/11.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No "groups" were assigned. Pts received chemotherapy based on their disease. 39 patients consented to study but 36 patients received protocol treatment. 3 patients were considered screen failures and did not move forward on study.

Reporting Groups
  Description
Hematopoietic Stem Cell Transplantation All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type

Participant Flow:   Overall Study
    Hematopoietic Stem Cell Transplantation  
STARTED     36  
COMPLETED     36  
NOT COMPLETED     0  



  Baseline Characteristics
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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
Hematopoietic Stem Cell Transplantation All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type

Baseline Measures
    Hematopoietic Stem Cell Transplantation  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     33  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  56.44  ± 6.92  
Gender  
[units: participants]
 
Female     14  
Male     22  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Survival at Day 100   [ Time Frame: 100 day ]

2.  Secondary:   Overall Survival at 1 Year   [ Time Frame: 1 year ]

3.  Secondary:   Non-relapse Mortality at Day 100   [ Time Frame: Day 100 ]

4.  Secondary:   Non-relapse Mortality at 1 Year Post-transplant   [ Time Frame: 1 year ]

5.  Secondary:   Complete Donor Chimerism   [ Time Frame: 2 years ]

6.  Secondary:   Neutrophil Recovery   [ Time Frame: Day 100 ]

7.  Secondary:   Platelet Engraftment   [ Time Frame: Day 100 ]

8.  Secondary:   Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism   [ Time Frame: Day 100 ]

9.  Secondary:   Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant   [ Time Frame: patients were followed for 2 years ]

10.  Secondary:   Number of Patients Experiencing Chronic Graft Versus Host Disease   [ Time Frame: >100 days post-transplant ]

11.  Secondary:   Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant   [ Time Frame: 4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Scott R. Solomon, MD
Organization: Blood and Marrow Transplant Group of Georgia
phone: 404-255-1930
e-mail: ssolomon@bmtga.com


Publications:


Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT00818961     History of Changes
Other Study ID Numbers: CDR0000630617, BMTGG-NSH-756
Study First Received: January 7, 2009
Results First Received: March 22, 2013
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration