Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma
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ClinicalTrials.gov Identifier: NCT00057954 |
Recruitment Status :
Terminated
(Slow accrual)
First Posted : April 9, 2003
Results First Posted : February 8, 2013
Last Update Posted : February 13, 2013
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Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
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Study Type | Interventional |
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Study Design | Allocation: N/A; 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) |
Enrollment | 6 |
Participant Flow
Recruitment Details | Participants were recruited from ECOG member institutions between June 1, 2005 and October 10, 2007. |
Pre-assignment Details |
Arm/Group Title | Transplant |
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Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant. |
Period Title: Overall Study | |
Started | 6 |
Completed | 4 |
Not Completed | 2 |
Reason Not Completed | |
Death | 1 |
Disease progression | 1 |
Baseline Characteristics
Arm/Group Title | Transplant | |
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Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant. | |
Overall Number of Baseline Participants | 6 | |
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[Not Specified]
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Age Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 6 participants | |
47
(21 to 60)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | |
Female |
2 33.3%
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Male |
4 66.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 6 participants |
6 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |
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 |