Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Stem Cell Transplant for Hematologic Diseases (HIMSUM)

This study has been terminated.
(Slow accrual due to practice changes meant study would take too long to finish)
Sponsor:
Collaborators:
Texas Children's Hospital
The Methodist Hospital System
Information provided by (Responsible Party):
George Carrum, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00058825
First received: April 11, 2003
Last updated: September 20, 2016
Last verified: September 2016
Results First Received: September 23, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hematologic Malignancies
Interventions: Biological: Campath 1H
Drug: Fludarabine
Procedure: Stem Cell Transplant
Radiation: Total Body Irradiation (TBI)
Drug: FK506 (Tacrolimus) or Cyclosporine

  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
Stem Cell Transplant

Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.

Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.

Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.

Stem Cell Transplant: Day 0: Donor stem cells infused.

Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.

FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD.


Participant Flow:   Overall Study
    Stem Cell Transplant
STARTED   27 
COMPLETED   5 
NOT COMPLETED   22 
Relapse                9 
Progressive Disease                5 
Graft Failure                5 
Death                3 



  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
Stem Cell Transplant

Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.

Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.

Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.

Stem Cell Transplant: Day 0: Donor stem cells infused.

Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.

FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD.


Baseline Measures
   Stem Cell Transplant 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age 
[Units: Years]
Median (Full Range)
 15 
 (2 to 65) 
Gender 
[Units: Participants]
 
Female   8 
Male   19 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   14 
Not Hispanic or Latino   13 
Unknown or Not Reported   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Transplant Related Mortality (TRM)   [ Time Frame: 100 days ]

2.  Secondary:   Time in Days to ANC Engraftment   [ Time Frame: 30 days ]

3.  Secondary:   Donor Chimerism Engraftment of Greater Than 50%   [ Time Frame: 30 days ]

4.  Secondary:   Acute Graft Versus Host Disease   [ Time Frame: 100 days ]

5.  Secondary:   Chronic Graft Versus Host Disease   [ Time Frame: 1 year ]

6.  Secondary:   2-year Relapse-free Survival   [ Time Frame: 2 years ]

7.  Secondary:   2-year Overall Survival   [ Time Frame: 2 years ]

8.  Secondary:   Number of Patients Who Engrafted With the Isolex/CLINIMACs System   [ Time Frame: 30 days ]

9.  Secondary:   Median Time to Engraftment With the Isolex/CLINIMACs System   [ Time Frame: 30 days ]


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


Results Point of Contact:  
Name/Title: George Carrum, MD
Organization: Baylor College of Medicine
e-mail: GCarrum@houstonmethodist.org



Responsible Party: George Carrum, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00058825     History of Changes
Other Study ID Numbers: 8713-HIMSUM
Study First Received: April 11, 2003
Results First Received: September 23, 2015
Last Updated: September 20, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board