Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marco Mielcarek, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00929695
First received: June 25, 2009
Last updated: October 8, 2014
Last verified: October 2014
Results First Received: September 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Graft Versus Host Disease
Recurrent Adult Acute Lymphoblastic Leukemia
Interventions: Drug: prednisone
Drug: methylprednisolone
Other: questionnaire administration

  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
Group A (Low-dose) Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Group B (Standard-dose) Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.

Participant Flow:   Overall Study
    Group A (Low-dose)     Group B (Standard-dose)  
STARTED     81     83  
COMPLETED     73     77  
NOT COMPLETED     8     6  
Death                 2                 1  
Withdrawal by Subject                 0                 2  
discharge home                 4                 3  
incorrect stratification                 2                 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.
From a total enrollment of 164 patients, 150 were analyzed for the primary endpoint. Excluded from the analysis were 14 patients: 12 withdrew, died or were discharged from the Center early and did not have 42 days of cumulative prednisone dosing and 2 were stratified incorrectly.

Reporting Groups
  Description
Group A (Low-dose) Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Group B (Standard-dose) Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Total Total of all reporting groups

Baseline Measures
    Group A (Low-dose)     Group B (Standard-dose)     Total  
Number of Participants  
[units: participants]
  73     77     150  
Age  
[units: participants]
     
<=18 years     8     14     22  
Between 18 and 65 years     59     56     115  
>=65 years     6     7     13  
Gender  
[units: participants]
     
Female     31     26     57  
Male     42     51     93  



  Outcome Measures
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1.  Primary:   Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment   [ Time Frame: At day 42 after initiation of treatment ]

2.  Secondary:   Prednisone-associated Toxicity as Assessed by Hyperglycemia   [ Time Frame: Baseline and then through 42 days after starting treatment ]

3.  Secondary:   Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)   [ Time Frame: Baseline and through 100 days of treatment ]

4.  Secondary:   Prednisone-associated Toxicity as Assessed by Myopathy   [ Time Frame: Baseline and then weekly until 42 days after starting treatment ]

5.  Secondary:   Prednisone-associated Toxicity as Assessed by Hypertension   [ Time Frame: Baseline and then through 42 days after starting treatment ]

6.  Secondary:   Prednisone-associated Toxicity as Assessed by Quality of Life   [ Time Frame: Baseline and then every other week until 42 days after starting treatment ]

7.  Secondary:   Non-relapse Mortality   [ Time Frame: At 12 months after the start of prednisone therapy ]

8.  Secondary:   Recurrent or Progressive Malignancy   [ Time Frame: At 12 months after the start of prednisone therapy ]

9.  Secondary:   Progression to Grade III-IV Acute GVHD   [ Time Frame: At approximately 100 days after transplant ]

10.  Secondary:   Secondary Therapy for Acute GVHD Beyond Prednisone   [ Time Frame: At approximately 100 days after transplant ]

11.  Secondary:   Chronic Extensive GVHD   [ Time Frame: At 12 months after the start of prednisone therapy ]

12.  Secondary:   Overall Survival   [ Time Frame: At 12 months after the start of prednisone therapy ]


  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: Marco Mielcarek
Organization: Fred Hutchinson Cancer Research Center
phone: 206-667-2827
e-mail: mmielcar@fhcrc.org


No publications provided


Responsible Party: Marco Mielcarek, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00929695     History of Changes
Other Study ID Numbers: 2327.00, NCI-2010-00323, P01CA018029
Study First Received: June 25, 2009
Results First Received: September 19, 2014
Last Updated: October 8, 2014
Health Authority: United States: Federal Government