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Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00589563
First received: December 21, 2007
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: July 21, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Infection
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Precancerous Condition
Secondary Myelofibrosis
Small Intestine Cancer
Interventions: Biological: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: etoposide
Drug: fludarabine phosphate
Drug: melphalan
Drug: methotrexate
Drug: sirolimus
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: hematopoietic stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: total-body 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
All Patients All patients were analyzed as a single population. Stratification by conditioning regimen was not done.

Participant Flow:   Overall Study
    All Patients
STARTED   32 
COMPLETED   32 
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.
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Reporting Groups
  Description
All Patients All patients were analyzed as a single population. Stratification by conditioning regimen was not done.

Baseline Measures
   All Patients 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Years]
Median (Full Range)
 59.5 
 (19 to 71) 
Gender 
[Units: Participants]
 
Female   19 
Male   13 
Region of Enrollment 
[Units: Participants]
 
United States   32 
Diagnosis [1] 
[Units: Participants]
 
Acute Myeloid Leukemia   14 
Myelodysplastic Syndrome   6 
Acute Lymphoblastic Leukemia   3 
Chronic Myeloid Leukemia   3 
Non-Hodgkin Lymphoma   3 
Myeloproliferative Disorder   2 
Chronic Lymphocytic Leukemia   1 
[1] Diagnosis at time of transplant.
Disease Status (American Society for Blood and Marrow Transplantation Guidelines) [1] 
[Units: Participants]
 
Standard Risk   14 
High/Intermediate Risk   18 
[1] Disease status at time of transplant.
Patient/Donor Cytomegalovirus (CMV) infection status [1] 
[Units: Participants]
 
Positive/Negative   12 
Positive/Positive   12 
Negative/Negative   3 
Negative/Positive   5 
[1] Patient CMV status listed first followed by Donor CMV status. Both are determined at time of transplant.
Human Leukocyte Antigen (HLA) Match Type [1] 
[Units: Participants]
 
10/10 Matched   18 
1 Mismatch   12 
2 Mismatches   1 
3 Mismatches   1 
[1] All mismatches occur at A, B, C, or DR.
Conditioning Regimen 
[Units: Participants]
 
Fludarabine/Melphalan   23 
Fractionated Total Body Irradiation/Cytoxan   4 
Fractionated Total Body Irradiation/Etoposide   5 
Patient/donor sex match 
[Units: Participants]
 
Male patient/Female donor   3 
Others   29 


  Outcome Measures
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1.  Primary:   Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100   [ Time Frame: 100 Days Post Hematopoietic Stem Cell Transplant (HSCT) ]

2.  Primary:   Severity of Acute GVHD   [ Time Frame: 100 Days Post HSCT ]

3.  Primary:   Cumulative Incidence of Chronic GVHD   [ Time Frame: 2 year point estimate was provided. ]

4.  Primary:   Severity of Chronic GVHD   [ Time Frame: Patients were evaluated until they developed chronic GVHD, a median of 130 days post HSCT ]

5.  Secondary:   Time to Absolute Neutrophil Count Recovery (Engraftment)   [ Time Frame: Patients were evaluated until neutrophil recovery, a median of 15 days post HSCT ]

6.  Secondary:   Time to Platelet Count Recovery (Engraftment)   [ Time Frame: Patients were evaluated until platelet recovery, a median of 14 days ]

7.  Secondary:   Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation   [ Time Frame: Median Follow Up: 28 months (Range: 1-49 months) ]

8.  Secondary:   Occurrence of Thrombotic Microangiopathy   [ Time Frame: Median Follow Up: 28 Months (Range: 1-49 months) ]

9.  Secondary:   Occurence of Sinusoidal Obstructive Syndrome (SOS)   [ Time Frame: Median Follow Up: 28 Months (Range: 1-49 Months) ]

10.  Secondary:   Non-relapse Mortality at 100 Days Post HSCT   [ Time Frame: 100 day point estimate was provided ]

11.  Secondary:   Non-relapse Mortality at Two Years Post HSCT   [ Time Frame: 2 year point estimate was provided. ]

12.  Secondary:   Overall Survival at Two Years Post HSCT   [ Time Frame: 2 year point estimate was provided. ]

13.  Secondary:   Event Free Survival at Two Years Post HSCT   [ Time Frame: 2 year point estimate was provided. ]

14.  Secondary:   Incidence of Disease Relapse/Progression at 2 Years Post HSCT   [ Time Frame: 2 year point estimate was provided. ]


  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: Dr. Ryotaro Nakamura
Organization: City of Hope Medical Center
phone: 626-256-4673 ext 65285
e-mail: rnakamura@coh.org



Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00589563     History of Changes
Other Study ID Numbers: 06141
P30CA033572 ( US NIH Grant/Contract Award Number )
CHNMC-06141
CDR0000579340 ( Registry Identifier: NCI PDQ )
Study First Received: December 21, 2007
Results First Received: July 21, 2014
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board