Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma

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. Identifier: NCT00057954
Recruitment Status : Terminated (Slow accrual)
First Posted : April 9, 2003
Results First Posted : February 8, 2013
Last Update Posted : February 13, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Procedure: Extracorporeal Photopheresis
Drug: Pentostatin
Radiation: Total body irradiation (TBI)
Procedure: Allogeneic bone marrow transplantation
Drug: Cyclosporin (CSA)
Drug: Mycophenolate mofetil (MMF)
Drug: Methotrexate (MTX)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from ECOG member institutions between June 1, 2005 and October 10, 2007.

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
Transplant Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.

Participant Flow:   Overall Study
Death                1 
Disease progression                1 

  Baseline Characteristics

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
Transplant Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (21 to 60) 
[Units: Participants]
Female   2 
Male   4 
Region of Enrollment 
[Units: Participants]
United States   6 

  Outcome Measures

1.  Primary:   Proportion of Participants With Successful Engraftment   [ Time Frame: Assessed daily during inpatient stay ]

2.  Secondary:   100-day Overall Survival   [ Time Frame: Assessed at least twice a week for the first 60 days and weekly until day 100. ]

3.  Secondary:   Progression-free Survival   [ Time Frame: Assessed day 100 post transplant and every 3 months during year 1, every 6 months during years 2-3, then every 12 months during years 4-5 or through diagnosis of disease progression ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012

Responsible Party: Eastern Cooperative Oncology Group Identifier: NCT00057954     History of Changes
Other Study ID Numbers: CDR0000285659
U10CA021115 ( U.S. NIH Grant/Contract )
E1402 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
First Submitted: April 7, 2003
First Posted: April 9, 2003
Results First Submitted: January 7, 2013
Results First Posted: February 8, 2013
Last Update Posted: February 13, 2013