Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative 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 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
Recruitment Details Participants were recruited from ECOG member institutions between June 1, 2005 and October 10, 2007.
Pre-assignment Details  
Arm/Group Title Transplant
Hide Arm/Group Description 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
Arm/Group Title Transplant
Hide Arm/Group Description Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
47
(21 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Proportion of Participants With Successful Engraftment
Hide Description [Not Specified]
Time Frame Assessed daily during inpatient stay
Hide Outcome Measure Data
Hide Analysis Population Description
all enrolled 6 patients
Arm/Group Title Transplant
Hide Arm/Group Description:
Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
Overall Number of Participants Analyzed 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
1
(0.5 to 1.0)
2.Secondary Outcome
Title 100-day Overall Survival
Hide Description Proportion of patients who survived 100 days or more after enrolled on the study
Time Frame Assessed at least twice a week for the first 60 days and weekly until day 100.
Hide Outcome Measure Data
Hide Analysis Population Description
all 6 enrolled patients
Arm/Group Title Transplant
Hide Arm/Group Description:
Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
Overall Number of Participants Analyzed 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.83
(0.54 to 1.0)
3.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival was defined as time from enrollment to disease progression or death from any cause, whichever occurred first. Patients who did not have progression-free survival events were censored at last date of disease assessment.
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
Hide Outcome Measure Data
Hide Analysis Population Description
all 6 enrolled patients
Arm/Group Title Transplant
Hide Arm/Group Description:
Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
Overall Number of Participants Analyzed 6
Median (95% Confidence Interval)
Unit of Measure: days
104 [1] 
(66 to NA)
[1]
upper limit of confidence interval (CI) has not been reached
Time Frame Assessed every 30 days while on treatment and for 30 days after the end of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transplant
Hide Arm/Group Description Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
All-Cause Mortality
Transplant
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Transplant
Affected / at Risk (%)
Total   6/6 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  1/6 (16.67%) 
Gastrointestinal disorders   
Diarrhea w/o prior colostomy  1  1/6 (16.67%) 
Nausea  1  1/6 (16.67%) 
Vomiting  1  1/6 (16.67%) 
Abdomen, pain  1  2/6 (33.33%) 
General disorders   
Fatigue  1  2/6 (33.33%) 
Investigations   
Leukopenia (Leukocytes, decreased)  1  6/6 (100.00%) 
Lymphopenia  1  6/6 (100.00%) 
Neutropenia (Neutrophils, decreased)  1  6/6 (100.00%) 
Thrombocytopenia (Platelets, decreased)  1  4/6 (66.67%) 
Aspartate aminotransferase increased  1  1/6 (16.67%) 
Blood bilirubin increased  1  1/6 (16.67%) 
Metabolism and nutrition disorders   
Anorexia  1  2/6 (33.33%) 
Hypoalbuminemia  1  4/6 (66.67%) 
Hyponatremia  1  2/6 (33.33%) 
Musculoskeletal and connective tissue disorders   
Muscle, pain  1  1/6 (16.67%) 
Nervous system disorders   
Neuropathy-sensory  1  1/6 (16.67%) 
Head/headache  1  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/6 (33.33%) 
Pulmonary/Upper Respiratory-other  1  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Transplant
Affected / at Risk (%)
Total   6/6 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  6/6 (100.00%) 
Gastrointestinal disorders   
Diarrhea w/o prior colostomy  1  2/6 (33.33%) 
Nausea  1  1/6 (16.67%) 
Vomiting  1  1/6 (16.67%) 
GI-other  1  1/6 (16.67%) 
General disorders   
Fatigue  1  1/6 (16.67%) 
Fever w/o neutropenia  1  1/6 (16.67%) 
Investigations   
Leukopenia (Leukocytes, decreased)  1  6/6 (100.00%) 
Lymphopenia  1  5/6 (83.33%) 
Neutropenia (Neutrophils, decreased)  1  5/6 (83.33%) 
Thrombocytopenia (Platelets, decreased)  1  6/6 (100.00%) 
Alanine aminotransferase increased  1  3/6 (50.00%) 
Aspartate aminotransferase increased  1  4/6 (66.67%) 
Blood bilirubin increased  1  6/6 (100.00%) 
Creatinine, increased  1  5/6 (83.33%) 
Metabolism and nutrition disorders   
Hypoalbuminemia  1  6/6 (100.00%) 
Musculoskeletal and connective tissue disorders   
Extremity-limb, pain  1  1/6 (16.67%) 
Joint, pain  1  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/6 (16.67%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  1/6 (16.67%) 
Erythema multiforme  1  2/6 (33.33%) 
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: ECOG Statistical Office
Phone: 617-632-3012
Layout table for additonal information
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