Trial · NCT00153985
Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies
NCT00153985, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2013-03-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies. Trials, record NCT00153985. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00153985
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies
- NCT number
- NCT00153985
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Hemoglobinopathies, Sickle Cell Disease, Thalassemia
- Interventions
- Busulfex, Fludarabine, Alemtuzumab, Stem Cell Transfusion
- First posted
- 2005-09-12
- Last updated
- 2013-07-30
- Results first posted
- 2013-03-12
- Limitations and caveats
- Early termination leading to small numbers of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stable Engraftment With Donor Stem Cells in Patients With Severe Hemoglobinopathy. | 3 years | Outcome was measured by ANC \>500 for three consecutive days prior to day 30 after PBSC infusion, \>25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods prior to day 45 after PBSC infusion and \>25% of hematopoietic cells are donor derived as determined by molecular chimerism assays or cytogenetic methods after day 180 after PBSC infusion. |
| Secondary | Solid Organ Toxicity Related to the Conditioning Regimen. | 3 years | Outcome was measured by the assessment of organ toxicity related to Busulfex, fludarabine and alemtuzumab. |
| Secondary | The Incidence of Grade II-IV Acute Graft vs. Host Disease. | 3 years | Outcome was measured by incidence and severity of acute and chronic GVHD following donor stem cell infusion. |
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 | Stable Engraftment With Donor Stem Cells in Patients With Severe Hemoglobinopathy. | 3 years | All patients enrolled. | participants | NUMBER |
| SECONDARY | Solid Organ Toxicity Related to the Conditioning Regimen. | 3 years | All patients enrolled. | participants | NUMBER |
| SECONDARY | The Incidence of Grade II-IV Acute Graft vs. Host Disease. | 3 years | All patients enrolled. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Stable Engraftment With Donor Stem Cells in Patients With Severe Hemoglobinopathy. | Transplant for Severe Hemoglobinopathies | 2 | participants | ||
| Solid Organ Toxicity Related to the Conditioning Regimen. | Transplant for Severe Hemoglobinopathies | 2 | participants | ||
| The Incidence of Grade II-IV Acute Graft vs. Host Disease. | Transplant for Severe Hemoglobinopathies | 2 | 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 | Transplant for Severe Hemoglobinopathies | 2 | |
| Overall Study | COMPLETED | Transplant for Severe Hemoglobinopathies | 2 | |
| Overall Study | NOT COMPLETED | Transplant for Severe Hemoglobinopathies | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Infection | Infections and infestations | Transplant for Severe Hemoglobinopathies | 1 | 2 | 1 |
| serious | Graft versus host disease | Immune system disorders | Transplant for Severe Hemoglobinopathies | 1 | 2 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Transplant for Severe Hemoglobinopathies | ||
| Total, other adverse events | Transplant for Severe Hemoglobinopathies | 1 | 2 |
| Total, serious adverse events | Transplant for Severe Hemoglobinopathies | 1 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18550258 | RESULT |
Source PubMed
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/NCT00153985
GET https://conductscience.org/api/trials/v1/NCT00153985/registered