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Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00185640
First Posted: September 16, 2005
Last Update Posted: October 3, 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.
Information provided by (Responsible Party):
Robert Lowsky, Stanford University
Results First Submitted: December 1, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Blood Cancer
Leukemia
Interventions: Drug: Cyclosporine
Drug: Anti-Thymocyte Globulin
Drug: mycophenolate mofetil
Drug: Granulocyte-Colony Stimulating Factor
Radiation: Total Lymphoid Irradiation

  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
Non-myeloablative Transplantation

Cyclosporine: 3 to 5 mg/kg twice-a-day (BID); intravenous (IV) or oral

Thymoglobulin: 7.5 to 10 mg/kg; IV

Mycophenolate mofetil: 15 mg/kg BID or Q 8 hours

G-CSF: 16 mcg/kg; subcutaneous (SQ)


Participant Flow:   Overall Study
    Non-myeloablative Transplantation
STARTED   303 
Transplanted   296 
90 Days Post-transplant   161 
COMPLETED   158 
NOT COMPLETED   145 
Not Eligible                4 
Withdrawal by Subject                3 
Death                138 



  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.
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Reporting Groups
  Description
Non-myeloablative Transplantation

Cyclosporine: 3 to 5 mg/kg BID; IV or oral

Thymoglobulin: 7.5 to 10 mg/kg; IV

Mycophenolate mofetil: 15 mg/kg BID or Q 8 hours

G-CSF: 16 mcg/kg; SQ


Baseline Measures
   Non-myeloablative Transplantation 
Overall Participants Analyzed 
[Units: Participants]
 303 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      260  85.8% 
>=65 years      43  14.2% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      128  42.2% 
Male      175  57.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      20   6.6% 
Not Hispanic or Latino      276  91.1% 
Unknown or Not Reported      7   2.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      37  12.2% 
Native Hawaiian or Other Pacific Islander      7   2.3% 
Black or African American      6   2.0% 
White      233  76.9% 
More than one race      0   0.0% 
Unknown or Not Reported      20   6.6% 
Histology 
[Units: Participants]
 
Acute Biphenotypic Leukemia   1 
Acute Leukemia, Nos   1 
Acute Monocytic Leukemia   2 
Acute Myeloid Leukemia   84 
Acute Promyelocytic Leukemia   4 
Angioimmunoblastic T-Cell Lymphoma   1 
B lymphoblastic leukemia/lymphoma, NOS   1 
B-Cell Chr. Lymph. Leuk./Small Lymph. Lymphoma   45 
Chronic Myelogenous Leukemia, Bcr/Abl Positive   1 
Chronic Myeloid Leukemia, Nos   8 
Chronic Myeloproliferative Disease, Nos   2 
Cutaneous T-Cell Lymphoma, Nos   1 
Follicular Lymphoma, Grade 1-3   4 
Hodgkin Lymphoma, Nodular Sclerosis, Nos   4 
Hodgkin Lymphoma, Nos   20 
Malignant Lymphoma, Non-Hodgkin   86 
Mantle Cell Lymphoma   10 
Marginal Zone B-Cell Lymphoma, Nos   2 
Mature T-Cell Lymphoma, Nos   1 
Ml, Large B-Cell, Diffuse   2 
Ml, Small B Lymphocytic, Nos   1 
Myelodysplastic Syndrome, Nos   3 
Precursor Cell Lymphoblastic Leukemia, Nos   15 
Prolymphocytic Leukemia, Nos   1 
Prolymphocytic Leukemia, T-Cell Type   1 
Subcutaneous Panniculitis-Like T-Cell Lymphoma   1 
Unknown   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Acute Graft vs Host Disease (GvHD)   [ Time Frame: 100 days post-transplant ]

2.  Secondary:   Acute Graft vs Host Disease (GvHD), All Evaluable   [ Time Frame: 100 days post-transplant ]

3.  Secondary:   Incidence of Relapse   [ Time Frame: 3 years ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: 3 and 5 years ]

5.  Secondary:   Event-free Survival (EFS)   [ Time Frame: 3 and 5 years ]

6.  Secondary:   Transplant-related Mortality   [ Time Frame: 1 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:  
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: Robert Lowsky
Organization: Stanford University
phone: 650-723-0822
e-mail: rlowsky@stanford.edu


Publications of Results:


Responsible Party: Robert Lowsky, Stanford University
ClinicalTrials.gov Identifier: NCT00185640     History of Changes
Obsolete Identifiers: NCT00186615
Other Study ID Numbers: IRB-11960
78998 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BMT153 ( Other Identifier: OnCore )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: December 1, 2016
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017