Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Clinic patients were recruited from August 2005 through March 2008.

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
Etanercept	Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
Mycophenolate Mofetil	Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
Denileukin Diftitox	Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
Pentostatin	Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.

Participant Flow:   Overall Study

	Etanercept	Mycophenolate Mofetil	Denileukin Diftitox	Pentostatin
STARTED	46	45	47	42
COMPLETED	46	45	46	42
NOT COMPLETED	0	0	1	0
Withdrawal by Subject	0	0	1	0

Reporting Groups

	Description
Etanercept	Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
Mycophenolate Mofetil	Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
Denileukin Diftitox	Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
Pentostatin	Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.

Baseline Measures

	Etanercept	Mycophenolate Mofetil	Denileukin Diftitox	Pentostatin	Total
Number of Participants   [units: participants]	46	45	47	42	180
Age   [units: years] Mean ± Standard Deviation	45.9  ± 15.2	40.6  ± 14.6	47.4  ± 15.8	50.5  ± 12.1	46.0  ± 14.9
Gender   [units: participants]
Female	16	17	19	15	67
Male	30	28	28	27	113
Region of Enrollment   [units: participants]
United States	46	45	47	42	180

1.  Primary:

Number of Complete Response (CR) at Day 28 of Therapy   [ Time Frame: Measured at Day 28 ]

2.  Secondary:

Number of Partial Response (PR), Mixed Response (MR), and Progression   [ Time Frame: Measured at Day 28 ]

3.  Secondary:

Number of Patients With Acute Graft-versus-host Disease (GVHD) Flares at Day 90   [ Time Frame: Measured at Day 90 ]

4.  Secondary:

Number of Patients Discontinuing Immune Suppression Without Flare   [ Time Frame: Measured at Days 90, 180, and 270 post-treatment ]

5.  Secondary:

Number of Patients With Chronic Graft-versus-host Disease(GVHD) at 9 Months   [ Time Frame: Measured at 9 months ]

6.  Secondary:

Number of Patients Surviving at 6 and 9 Months Post Randomization   [ Time Frame: Measured at 6 and 9 months ]

7.  Secondary:

Proportion of Treatment Failure   [ Time Frame: Measured at Day 14 ]

8.  Secondary:

Incidence of Systemic Infections Within 3 Months of Initiation of Therapy   [ Time Frame: Measured at 3 months ]

9.  Secondary:

Incidence of EBV-associated Lymphoma   [ Time Frame: Measured at 9 months ]