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:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00589563
First received: December 21, 2007
Last updated: July 21, 2014
Last verified: July 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  
Number of Participants  
[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]
 
AML     14  
MDS     6  
ALL     3  
CML     3  
NHL     3  
MPD     2  
CLL     1  
Disease Status (ASBMT) [2]
[units: participants]
 
Standard Risk     14  
High/Intermediate Risk     18  
Patient/Donor CMV status [3]
[units: participants]
 
Positive/Negative     12  
Positive/Positive     12  
Negative/Negative     3  
Negative/Positive     5  
HLA Match Type [4]
[units: participants]
 
10/10 Matched     18  
1 Mismatch     12  
2 Mismatches     1  
3 Mismatches     1  
Conditioning Regimen  
[units: participants]
 
Fludarabine/Melphalan     23  
Fractionated TBI/Cyclophosphamide     4  
Fractionated TBI/Etoposide     5  
Patient/donor sex match  
[units: participants]
 
Male patient/Female donor     3  
Others     29  
[1] Diagnosis at time of transplant.
[2] Disease status at time of transplant.
[3] Patient CMV status listed first followed by Donor CMV status. Both are determined at time of transplant.
[4] All mismatches occur at A, B, C, or DR.



  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: Time to Chronic GVHD ]

5.  Secondary:   Time to Absolute Neutrophil Count Recovery (Engraftment)   [ Time Frame: Time to Neutrophil Count Recovery ]

6.  Secondary:   Time to Platelet Count Recovery (Engraftment)   [ Time Frame: Time to Platelet Recovery ]

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


No publications provided


Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00589563     History of Changes
Other Study ID Numbers: 06141, P30CA033572, CHNMC-06141, CDR0000579340
Study First Received: December 21, 2007
Results First Received: July 21, 2014
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board