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S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma

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ClinicalTrials.gov Identifier: NCT00121186
Recruitment Status : Terminated (poor accrual)
First Posted : July 21, 2005
Results First Posted : April 3, 2012
Last Update Posted : April 3, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Drug: fludarabine phosphate
Drug: melphalan
Drug: methotrexate
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nonmyeloablative Allogeneic Stem Cell Transplant
Hide Arm/Group Description Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Nonmyeloablative Allogeneic Stem Cell Transplant
Hide Arm/Group Description Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
47.2
(47.2 to 47.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Progression-free Survival
Hide Description PFS rate at 1 year.
Time Frame 1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonmyeloablative Allogeneic Stem Cell Transplant
Hide Arm/Group Description:
Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
1
2.Primary Outcome
Title Overall Survival
Hide Description OS rate at 1 year.
Time Frame 1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nonmyeloablative Allogeneic Stem Cell Transplant
Hide Arm/Group Description:
Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
1
Time Frame After transplant, and after every month of protocol treatment, for a maximum of 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nonmyeloablative Allogeneic Stem Cell Transplant
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Nonmyeloablative Allogeneic Stem Cell Transplant
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Nonmyeloablative Allogeneic Stem Cell Transplant
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nonmyeloablative Allogeneic Stem Cell Transplant
Affected / at Risk (%)
Total   1/1 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  1/1 (100.00%) 
Eye disorders   
Dry eye syndrome  1  1/1 (100.00%) 
Gastrointestinal disorders   
Diarrhea  1  1/1 (100.00%) 
Nausea  1  1/1 (100.00%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  1/1 (100.00%) 
Investigations   
Leukocytes (total WBC)  1  1/1 (100.00%) 
Lymphopenia  1  1/1 (100.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  1/1 (100.00%) 
Platelets  1  1/1 (100.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  1/1 (100.00%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  1/1 (100.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00121186    
Other Study ID Numbers: CDR0000435930
S0501 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2005
First Posted: July 21, 2005
Results First Submitted: March 5, 2012
Results First Posted: April 3, 2012
Last Update Posted: April 3, 2012