Trial Outcomes & Findings for Bone Marrow Transplantation, Hemoglobinopathies, SCALLOP (NCT NCT00578344)
NCT ID: NCT00578344
Last Updated: 2020-07-31
Results Overview
Assess Number of participants that recovered organ function diagnosed with sickle cell disease (SCD) or sickle hemoglobin variants after undergoing allogeneic SCT/BMT from HLA genotype identical donors.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
One year
Results posted on
2020-07-31
Participant Flow
Participant milestones
| Measure |
Allogeneic BMT/SCT Transplant
Busulfan, Campath 1H, Cyclophosphamide and MESNA:
Bone marrow infusion with pre-meds as per SOPs to take place on Day 0.
Bone marrow dose: To ensure the probability for bone marrow engraftment, 4 x 10\^8 nucleated cells/kg patient weight will be the target at donor bone marrow harvest.
Busulfan: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.
Campath 1H: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.
Cyclophosphamide and MESNA: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Allogeneic BMT/SCT Transplant
Busulfan, Campath 1H, Cyclophosphamide and MESNA:
Bone marrow infusion with pre-meds as per SOPs to take place on Day 0.
Bone marrow dose: To ensure the probability for bone marrow engraftment, 4 x 10\^8 nucleated cells/kg patient weight will be the target at donor bone marrow harvest.
Busulfan: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.
Campath 1H: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.
Cyclophosphamide and MESNA: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA.
|
|---|---|
|
Overall Study
Insurance problems
|
1
|
|
Overall Study
Graft failure
|
1
|
Baseline Characteristics
Bone Marrow Transplantation, Hemoglobinopathies, SCALLOP
Baseline characteristics by cohort
| Measure |
Allogeneic BMT/SCT Transplant
n=8 Participants
Busulfan, Campath 1H, Cyclophosphamide and MESNA:
Bone marrow infusion with pre-meds as per SOPs to take place on Day 0.
Bone marrow dose: To ensure the probability for bone marrow engraftment, 4 x 10\^8 nucleated cells/kg patient weight will be the target at donor bone marrow harvest.
Busulfan: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.
Campath 1H: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.
Cyclophosphamide and MESNA: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA.
|
|---|---|
|
Age, Continuous
|
8.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: Out of eight participants who underwent bone marrow transplant, six participants with positron emission tomography (PET) or magnetic resonance imaging (MRI) at the time of assessment were included in the analysis. The other two were inevaluable due to graft failure or no PET or MRI at the time of assessment. Data were collected at 1 year only.
Assess Number of participants that recovered organ function diagnosed with sickle cell disease (SCD) or sickle hemoglobin variants after undergoing allogeneic SCT/BMT from HLA genotype identical donors.
Outcome measures
| Measure |
Allogeneic BMT/SCT Transplant
n=6 Participants
Busulfan, Campath 1H, Cyclophosphamide and MESNA:
Bone marrow infusion with pre-meds as per SOPs to take place on Day 0.
Bone marrow dose: To ensure the probability for bone marrow engraftment, 4 x 10\^8 nucleated cells/kg patient weight will be the target at donor bone marrow harvest.
Busulfan: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.
Campath 1H: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.
Cyclophosphamide and MESNA: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA.
|
|---|---|
|
Number of Participants Evaluated for Evidence of Recovery of Organ Function Measured Via MRI or PET Scan.
Stable
|
4 Participants
|
|
Number of Participants Evaluated for Evidence of Recovery of Organ Function Measured Via MRI or PET Scan.
Progressive
|
2 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: All participants who underwent allogeneic bone marrow transplantation from human leukocyte antigen (HLA) identical related donors with hemoglobinopathies were included in the analysis.
Number of participants that did or did not have pre- and post- PET scans.
Outcome measures
| Measure |
Allogeneic BMT/SCT Transplant
n=8 Participants
Busulfan, Campath 1H, Cyclophosphamide and MESNA:
Bone marrow infusion with pre-meds as per SOPs to take place on Day 0.
Bone marrow dose: To ensure the probability for bone marrow engraftment, 4 x 10\^8 nucleated cells/kg patient weight will be the target at donor bone marrow harvest.
Busulfan: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.
Campath 1H: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.
Cyclophosphamide and MESNA: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA.
|
|---|---|
|
Number of Participants With Pre and Post Transplant PET Scan to Assess Organ Recovery Based on Rate of Acquisition.
No pre and post PET scan
|
6 Participants
|
|
Number of Participants With Pre and Post Transplant PET Scan to Assess Organ Recovery Based on Rate of Acquisition.
Pre and post PET scan
|
2 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsPopulation: Out of eight participants who underwent bone marrow transplant, seven participants engrafted were included in the analysis. The other participant was excluded because he/she did not engraft and received a second transplant.
Vaccine response will be measured via a humoral immunity panel evaluating streptococcus pneumonia IgG antibodies (microgram/mL). Panels are obtained pre and 1+ month post vaccination. Standard recommendations define a normal responder as having \>4 fold increase in antibody level in 50-70% of the serotypes found in the vaccine.
Outcome measures
| Measure |
Allogeneic BMT/SCT Transplant
n=7 Participants
Busulfan, Campath 1H, Cyclophosphamide and MESNA:
Bone marrow infusion with pre-meds as per SOPs to take place on Day 0.
Bone marrow dose: To ensure the probability for bone marrow engraftment, 4 x 10\^8 nucleated cells/kg patient weight will be the target at donor bone marrow harvest.
Busulfan: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.
Campath 1H: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.
Cyclophosphamide and MESNA: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA.
|
|---|---|
|
Number of Participants With Immune Response to Immunization After BMT in Participants With SCD, Hemoglobin SC, or Hemoglobin Sb0/+.
|
0 Participants
|
Adverse Events
Allogeneic BMT/SCT Transplant
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Allogeneic BMT/SCT Transplant
n=8 participants at risk
Busulfan, Campath 1H, Cyclophosphamide and MESNA:
Bone marrow infusion with pre-meds as per SOPs to take place on Day 0.
Bone marrow dose: To ensure the probability for bone marrow engraftment, 4 x 10\^8 nucleated cells/kg patient weight will be the target at donor bone marrow harvest.
Busulfan: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.
Campath 1H: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.
Cyclophosphamide and MESNA: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA.
|
|---|---|
|
Infections and infestations
Catheter-related infection
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Nervous system disorders
Seizure
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
Other adverse events
| Measure |
Allogeneic BMT/SCT Transplant
n=8 participants at risk
Busulfan, Campath 1H, Cyclophosphamide and MESNA:
Bone marrow infusion with pre-meds as per SOPs to take place on Day 0.
Bone marrow dose: To ensure the probability for bone marrow engraftment, 4 x 10\^8 nucleated cells/kg patient weight will be the target at donor bone marrow harvest.
Busulfan: Starting Day -9 / Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg.
Campath 1H: Day -5 through Day -2; Campath-1H dosed as per institutional guidelines.
Cyclophosphamide and MESNA: Day -5 through Day -2; Cyclophosphamide 50 mg/kg + MESNA.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 3 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
12.5%
1/8 • Number of events 2 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Investigations
Aspartate aminotransferase increased
|
75.0%
6/8 • Number of events 8 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Number of events 6 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Cardiac disorders
Cardiac disorders - Other: Prolonged QTc interval (QTc > 0.48 seconds)
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Cardiac disorders
Cardiac disorders - Other: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Infections and infestations
Catheter-related infection
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 4 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • Number of events 2 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Investigations
GGT increased
|
12.5%
1/8 • Number of events 2 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Psychiatric disorders
Hallucinations
|
25.0%
2/8 • Number of events 2 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Vascular disorders
Hypertension
|
25.0%
2/8 • Number of events 2 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Infections and infestations
Infections and infestations - Other: BK viremia
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Infections and infestations
Infections and infestations - Other: Candida Albicans in tongue culture
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Infections and infestations
Infections and infestations - Other: Parainfluenza 3 respiratory infection
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
3/8 • Number of events 3 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
|
|
Nervous system disorders
Seizure
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12.5%
1/8 • Number of events 2 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • Number of events 6 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Investigations
Weight loss
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12.5%
1/8 • Number of events 1 • Primary BMT studies have a critical toxicity period of 30 days after BMT day 0. During the critical toxicity period the most severe grade of all AE's is captured. Grade 1 and 2 AEs, hematological toxicities, and fevers are excluded. Serious Adverse Events/Unanticipated Problems are reported (excluding hematological toxicities and fevers) until 100 days after BMT day 0.
All adverse events were collected using CTCAE 2.0 for the study. For reporting purpose, adverse event terms were converted using CTCAE v4.0.
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Additional Information
Dr. Tami D. John
Baylor College of Medicine/Texas Children's Hospital
Phone: 832-824-4723
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place