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Total Body Irradiation/Fludarabine Based Ablative Haploidentical Transplant for Hematologic Diseases

This study has been completed.
Sponsor:
Collaborator:
Blood and Marrow Transplant Group of Georgia
Information provided by (Responsible Party):
Northside Hospital, Inc.
ClinicalTrials.gov Identifier:
NCT01336712
First received: April 14, 2011
Last updated: December 10, 2015
Last verified: December 2015
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Leukemia
Acute Leukemia
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Myelodysplastic Syndrome
Intervention: Procedure: Peripheral Blood Stem Cell Transplant

  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
Myeloablative Haploidentical Transplant

Haplo transplant

Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.

Fludarabine 30 mg/m^2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4

Patient follow up x6 months


Participant Flow:   Overall Study
    Myeloablative Haploidentical Transplant
STARTED   30 
COMPLETED   27 
NOT COMPLETED   3 
Death                2 
Lack of Efficacy                1 



  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
Myeloablative Haploidentical Transplant

Haplo transplant

Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.

Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4


Baseline Measures
   Myeloablative Haploidentical Transplant 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   30 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   17 
Male   13 
Race/Ethnicity, Customized 
[Units: Participants]
 
White   10 
Black/African America   20 


  Outcome Measures
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1.  Primary:   Percentage of Patients Experiencing Hemorrhagic Cystitis Post Transplant   [ Time Frame: 6 months ]

2.  Secondary:   Survival   [ Time Frame: 2 year ]

3.  Secondary:   Percentage of Participatns With Donor Chimerism Post-transplant   [ Time Frame: Day 30 ]

4.  Secondary:   Disease Free Survival (DFS) Percentage   [ Time Frame: 2 year ]

5.  Secondary:   Non-relapsed Mortality (NRM) Percentage   [ Time Frame: 2 year ]

6.  Secondary:   Relapse Rate   [ Time Frame: 2 year ]

7.  Secondary:   Cumulative Incidence of Chronic Graft-versus-host Disease   [ Time Frame: 2 year ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Scott R. Solomon, MD (Principal Investigator)
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: NCT01336712     History of Changes
Other Study ID Numbers: NSH 922
Study First Received: April 14, 2011
Results First Received: October 16, 2015
Last Updated: December 10, 2015
Health Authority: United States: Institutional Review Board