Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00054327
First received: February 5, 2003
Last updated: June 19, 2013
Last verified: June 2013
Results First Received: April 30, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Interventions: Drug: busulfan
Drug: cyclophosphamide
Drug: cytarabine
Radiation: radiation therapy
Drug: Etoposide
Procedure: Stem Cell Transfusion

  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
Thirty-five patients were recruited from local medical clinic from November 2000 through November 2009.One patient relapsed and never received a transplant.

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
Regimen A Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
Regimen B-1 Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
Regimen B-2 Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
Regimen B-3 Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
Regimen C Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
Regimen D Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.

Participant Flow:   Overall Study
    Regimen A     Regimen B-1     Regimen B-2     Regimen B-3     Regimen C     Regimen D  
STARTED     11     4     3     4     10     2  
COMPLETED     10     4     3     4     10     2  
NOT COMPLETED     1     0     0     0     0     0  
Engraftment failure                 1                 0                 0                 0                 0                 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
Regimen A Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
Regimen B-1 Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY.
Regimen B-2 Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
Regimen B-3 Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
Regimen C Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
Regimen D Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
Total Total of all reporting groups

Baseline Measures
    Regimen A     Regimen B-1     Regimen B-2     Regimen B-3     Regimen C     Regimen D     Total  
Number of Participants  
[units: participants]
  11     4     3     4     10     2     34  
Age  
[units: participants]
             
<=18 years     8     4     0     1     0     0     13  
Between 18 and 65 years     3     0     3     3     10     2     21  
>=65 years     0     0     0     0     0     0     0  
Gender  
[units: participants]
             
Female     4     2     1     3     5     1     16  
Male     7     2     2     1     5     1     18  
Ethnicity (NIH/OMB)  
[units: participants]
             
Hispanic or Latino     0     1     0     0     0     0     1  
Not Hispanic or Latino     11     3     3     4     10     2     33  
Unknown or Not Reported     0     0     0     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
             
American Indian or Alaska Native     0     0     0     0     0     0     0  
Asian     0     0     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0     0  
Black or African American     0     0     0     0     0     0     0  
White     11     4     3     4     10     2     34  
More than one race     0     0     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rates of Durable Engraftment   [ Time Frame: at day 42 ]

2.  Secondary:   Graft-versus-host Disease (GVHD)   [ Time Frame: at 100 days post transplant ]

3.  Secondary:   Incidence of Recurrent Disease   [ Time Frame: at day 100 post transplant ]

4.  Secondary:   Toxicity as Measured by CTC v2.0   [ Time Frame: at 100 days post transplant ]

5.  Post-Hoc:   Number of Patients With Overall Survival at 2 Years.   [ Time Frame: at 2 years from transplant ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Kenneth Cooke MD
Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
phone: 216-844-3345
e-mail: kenneth.cooke@uhhospitals.org


No publications provided


Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00054327     History of Changes
Other Study ID Numbers: CWRU1Y00, P30CA043703, CASE-CWRU-1Y00
Study First Received: February 5, 2003
Results First Received: April 30, 2013
Last Updated: June 19, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board