Trial · NCT00578344
Bone Marrow Transplantation, Hemoglobinopathies, SCALLOP
NCT00578344, Not applicable, Terminated, Tami D. John; results first posted 2020-07-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bone Marrow Transplantation, Hemoglobinopathies, SCALLOP. Trials, record NCT00578344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00578344
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bone Marrow Transplantation, Hemoglobinopathies, SCALLOP
- NCT number
- NCT00578344
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 8 participants, actual
- Lead sponsor
- Tami D. John
- Conditions
- Sickle Cell Disease, Hemoglobin SC
- Interventions
- Busulfan, Campath 1H, Cyclophosphamide and MESNA
- First posted
- 2007-12-21
- Last updated
- 2020-07-31
- Results first posted
- 2020-07-31
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Evaluated for Evidence of Recovery of Organ Function Measured Via MRI or PET Scan. | One year | 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. |
| Primary | Number of Participants With Pre and Post Transplant PET Scan to Assess Organ Recovery Based on Rate of Acquisition. | One year | Number of participants that did or did not have pre- and post- PET scans. |
| Primary | Number of Participants With Immune Response to Immunization After BMT in Participants With SCD, Hemoglobin SC, or Hemoglobin Sb0/+. | up to 12 months | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Evaluated for Evidence of Recovery of Organ Function Measured Via MRI or PET Scan. | One year | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Pre and Post Transplant PET Scan to Assess Organ Recovery Based on Rate of Acquisition. | One year | All participants who underwent allogeneic bone marrow transplantation from human leukocyte antigen (HLA) identical related donors with hemoglobinopathies were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Immune Response to Immunization After BMT in Participants With SCD, Hemoglobin SC, or Hemoglobin Sb0/+. | up to 12 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Evaluated for Evidence of Recovery of Organ Function Measured Via MRI or PET Scan. | Allogeneic BMT/SCT Transplant | Stable | 4 | Participants | |
| Number of Participants Evaluated for Evidence of Recovery of Organ Function Measured Via MRI or PET Scan. | Allogeneic BMT/SCT Transplant | Progressive | 2 | Participants | |
| Number of Participants With Pre and Post Transplant PET Scan to Assess Organ Recovery Based on Rate of Acquisition. | Allogeneic BMT/SCT Transplant | 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. | Allogeneic BMT/SCT Transplant | Pre and post PET scan | 2 | Participants | |
| Number of Participants With Immune Response to Immunization After BMT in Participants With SCD, Hemoglobin SC, or Hemoglobin Sb0/+. | Allogeneic BMT/SCT Transplant | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Allogeneic BMT/SCT Transplant | 8 | |
| Overall Study | COMPLETED | Allogeneic BMT/SCT Transplant | 6 | |
| Overall Study | NOT COMPLETED | Allogeneic BMT/SCT Transplant | 2 |
Source ClinicalTrials.gov
Adverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Allogeneic BMT/SCT Transplant | 1 | 8 | 1 |
| other | Alanine aminotransferase increased | Investigations | Allogeneic BMT/SCT Transplant | 1 | 8 | 3 |
| other | Anal hemorrhage | Gastrointestinal disorders | Allogeneic BMT/SCT Transplant | 1 | 8 | 2 |
| other | Anorexia | Metabolism and nutrition disorders | Allogeneic BMT/SCT Transplant | 1 | 8 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Allogeneic BMT/SCT Transplant | 6 | 8 | 8 |
| other | Blood bilirubin increased | Investigations | Allogeneic BMT/SCT Transplant | 1 | 8 | 6 |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Allogeneic BMT/SCT Transplant | 1 | 8 | 1 |
| other | Cardiac disorders - Other: Prolonged QTc interval (QTc > 0.48 seconds) | Cardiac disorders | Allogeneic BMT/SCT Transplant | 1 | 8 | 1 |
| other | Cardiac disorders - Other: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) | Cardiac disorders | Allogeneic BMT/SCT Transplant | 1 | 8 | 1 |
| other | Catheter-related infection | Infections and infestations | Allogeneic BMT/SCT Transplant | 1 | 8 | 1 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Allogeneic BMT/SCT Transplant | 0 | 8 |
| Total, other adverse events | Allogeneic BMT/SCT Transplant | 8 | 8 |
| Total, serious adverse events | Allogeneic BMT/SCT Transplant | 3 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00578344
GET https://conductscience.org/api/trials/v1/NCT00578344/events?page=2