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

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

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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
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

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

Participant Flow:   Overall Study

	Transplant
STARTED	6
COMPLETED	4
NOT COMPLETED	2
Death	1
Disease progression	1

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

Baseline Measures

	Transplant
Overall Participants Analyzed; [Units: Participants]	6
Age; [Units: Years]; Median (Full Range)	47; (21 to 60)
Gender; [Units: Participants]
Female	2
Male	4
Region of Enrollment; [Units: Participants]
United States	6

  Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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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 ]

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  Serious Adverse Events

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  Other Adverse Events

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  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:  

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
ClinicalTrials.gov 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