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Busulfan, Cyclophosphamide, and Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00611351
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lori Maness Harris, MD, University of Nebraska

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Secondary Myelofibrosis
Interventions Biological: anti-thymocyte globulin
Drug: busulfan
Drug: cyclophosphamide
Drug: mycophenolate mofetil
Drug: tacrolimus
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: flow cytometry
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
Other: pharmacological study
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Unrelated Donor Allogeneic
Hide Arm/Group Description Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
Period Title: Overall Study
Started 5
Completed 3
Not Completed 2
Arm/Group Title Unrelated Donor Allogeneic
Hide Arm/Group Description Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
50
(36 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
1
  20.0%
Male
4
  80.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Caucasian Number Analyzed 5 participants
5
 100.0%
1.Primary Outcome
Title Transplantation-related Mortality at 100 Days Post-transplantation
Hide Description [Not Specified]
Time Frame at the 100 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
count of participants reflects number of participants not alive at 100 days post transplant.
Arm/Group Title Unrelated Donor Allogeneic
Hide Arm/Group Description:
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
2
  40.0%
2.Secondary Outcome
Title Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)
Hide Description [Not Specified]
Time Frame at day 100 post transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
count of participants represents number of participants with documented acute GVHD prior to day 100 post transplant.
Arm/Group Title Unrelated Donor Allogeneic
Hide Arm/Group Description:
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
4
  80.0%
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 2 years post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Count of participants is the number of participant alive at the 2 year post transplant time point.
Arm/Group Title Unrelated Donor Allogeneic
Hide Arm/Group Description:
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
2
  40.0%
4.Secondary Outcome
Title Event-free Survival
Hide Description [Not Specified]
Time Frame 2 years post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants at 2 years that experienced event-free survival.
Arm/Group Title Unrelated Donor Allogeneic
Hide Arm/Group Description:
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
2
  40.0%
Time Frame Adverse events are collected from the time of consent until day plus 100 from transplant.
Adverse Event Reporting Description Grade 4 anemia, thrombocytopenia, and leucopenia, grade 3 dysphagia, and grade 3 infertility are routinely expected for all patients participating in this protocol, so these events were not reported. Multiple grade 1 and grade 2 toxicities are also expected for all patients participating in this protocol; these events will not routinely be reported. All other toxicities > grade 3 will be reported.
 
Arm/Group Title Unrelated Donor Allogeneic
Hide Arm/Group Description Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
All-Cause Mortality
Unrelated Donor Allogeneic
Affected / at Risk (%)
Total   2/5 (40.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Unrelated Donor Allogeneic
Affected / at Risk (%) # Events
Total   3/5 (60.00%)    
Infections and infestations   
Lung infection  1 [1]  1/5 (20.00%)  1
Infections and infestations - Other  1 [2]  1/5 (20.00%)  1
Investigations   
Blood bilirubin increased  1  1/5 (20.00%)  1
Investigations - Other  1 [3]  1/5 (20.00%)  1
Metabolism and nutrition disorders   
hyperglycemia  1  1/5 (20.00%)  1
Psychiatric disorders   
confusion  1  1/5 (20.00%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
aspergillus pneumonia
[2]
positive blood culture
[3]
plasmacytoma
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Unrelated Donor Allogeneic
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
Blood and lymphatic system - Other  1 [1]  1/5 (20.00%)  1
Febrile Neutropenia  1  4/5 (80.00%)  4
anemia  1  1/5 (20.00%)  1
Cardiac disorders   
acute coronary syndrome  1  1/5 (20.00%)  1
Gastrointestinal disorders   
Diarrhea  1  3/5 (60.00%)  3
General disorders   
Fatigue  1  2/5 (40.00%)  2
Immune system disorders   
Serum sickness  1  2/5 (40.00%)  2
Infections and infestations   
Infections and infestations - Other  1 [2]  1/5 (20.00%)  1
Encephalitis infection  1 [3]  1/5 (20.00%)  1
Encephalitis infection  1 [4]  1/5 (20.00%)  1
Endocarditis infective  1  1/5 (20.00%)  1
Investigations   
Blood bilirubin increased  1  3/5 (60.00%)  3
Platelet count decreased  1  2/5 (40.00%)  2
Neutrophil count decreased  1  1/5 (20.00%)  1
Metabolism and nutrition disorders   
Hypoalbuminemia  1  1/5 (20.00%)  1
Hyperglycemia  1  3/5 (60.00%)  3
hypocalcemia  1  1/5 (20.00%)  1
Anorexia  1  1/5 (20.00%)  1
hypernatremia  1  1/5 (20.00%)  1
hyponatremia  1  1/5 (20.00%)  1
Nervous system disorders   
syncope  1  1/5 (20.00%)  1
Seizure  1  1/5 (20.00%)  1
nervous system - Other  1 [5]  1/5 (20.00%)  1
Psychiatric disorders   
confusion  1  1/5 (20.00%)  1
Renal and urinary disorders   
Renal and Urinary disorders - Other  1 [6]  2/5 (40.00%)  2
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
hemorrhage
[2]
Epstein-Barr virus reactivation
[3]
HHV-6
[4]
septic emboli to brain
[5]
mental status change related to seizure activity
[6]
renal failure
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Lori Maness-Harris, MD
Organization: University of Nebraska Medical Center
Phone: 402-559-3848
Responsible Party: Lori Maness Harris, MD, University of Nebraska
ClinicalTrials.gov Identifier: NCT00611351     History of Changes
Other Study ID Numbers: 122-05
P30CA036727 ( U.S. NIH Grant/Contract )
UNMC-12205
First Submitted: February 7, 2008
First Posted: February 8, 2008
Results First Submitted: March 5, 2018
Results First Posted: April 3, 2018
Last Update Posted: April 3, 2018