Trial Outcomes & Findings for Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer (NCT NCT00611351)
NCT ID: NCT00611351
Last Updated: 2023-10-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
at the 100 days post-transplant
Results posted on
2023-10-23
Participant Flow
Participant milestones
| Measure |
Unrelated Donor Allogeneic
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer
Baseline characteristics by cohort
| Measure |
Unrelated Donor Allogeneic
n=5 Participants
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
|
|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at the 100 days post-transplantPopulation: count of participants reflects number of participants not alive at 100 days post transplant.
Outcome measures
| Measure |
Unrelated Donor Allogeneic
n=5 Participants
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
|
|---|---|
|
Transplantation-related Mortality at 100 Days Post-transplantation
|
2 Participants
|
SECONDARY outcome
Timeframe: at day 100 post transplantationPopulation: count of participants represents number of participants with documented acute GVHD prior to day 100 post transplant.
Outcome measures
| Measure |
Unrelated Donor Allogeneic
n=5 Participants
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
|
|---|---|
|
Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 years post transplantPopulation: Count of participants is the number of participant alive at the 2 year post transplant time point.
Outcome measures
| Measure |
Unrelated Donor Allogeneic
n=5 Participants
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
|
|---|---|
|
Overall Survival
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 years post transplantPopulation: Number of participants at 2 years that experienced event-free survival.
Outcome measures
| Measure |
Unrelated Donor Allogeneic
n=5 Participants
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
|
|---|---|
|
Event-free Survival
|
2 Participants
|
Adverse Events
Unrelated Donor Allogeneic
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Unrelated Donor Allogeneic
n=5 participants at risk
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
|
|---|---|
|
Investigations
Blood bilirubin increased
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Psychiatric disorders
confusion
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Investigations
Investigations - Other
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Infections and infestations
Infections and infestations - Other
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
Other adverse events
| Measure |
Unrelated Donor Allogeneic
n=5 participants at risk
Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
|
|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
60.0%
3/5 • Number of events 3 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Infections and infestations
Infections and infestations - Other
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system - Other
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Investigations
Blood bilirubin increased
|
60.0%
3/5 • Number of events 3 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
80.0%
4/5 • Number of events 4 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
3/5 • Number of events 3 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Immune system disorders
Serum sickness
|
40.0%
2/5 • Number of events 2 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Nervous system disorders
syncope
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Renal and urinary disorders
Renal and Urinary disorders - Other
|
40.0%
2/5 • Number of events 2 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Infections and infestations
Encephalitis infection
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Nervous system disorders
Seizure
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Nervous system disorders
nervous system - Other
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Metabolism and nutrition disorders
hypernatremia
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Blood and lymphatic system disorders
anemia
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Investigations
Platelet count decreased
|
40.0%
2/5 • Number of events 2 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Cardiac disorders
acute coronary syndrome
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Psychiatric disorders
confusion
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Infections and infestations
Endocarditis infective
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
|
Metabolism and nutrition disorders
hyponatremia
|
20.0%
1/5 • Number of events 1 • Adverse events are collected from the time of consent until day plus 100 from transplant.
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.
|
Additional Information
Lori Maness-Harris
University of Nebraska Medical Center
Phone: 402-559-3848
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place