Trial · NCT02435901
HSCT For Patients With High Risk Hemoglobinopathies Using Reduced Intensity
NCT02435901, Phase 1, Phase 2, Completed, Northwell Health; results first posted 2020-11-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. HSCT For Patients With High Risk Hemoglobinopathies Using Reduced Intensity. Trials, record NCT02435901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02435901
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HSCT For Patients With High Risk Hemoglobinopathies Using Reduced Intensity
- NCT number
- NCT02435901
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Northwell Health
- Conditions
- Sickle Cell Disease, Beta Thalassemia-Major
- Interventions
- alemtuzumab (Campath IH), Fludarabine, Melphalan, Cyclosporine, Mycophenolate mofetil, Tacrolimus, Hematopoietic Stem Cell Transplantation
- First posted
- 2015-05-06
- Last updated
- 2021-08-24
- Results first posted
- 2020-11-05
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 With Sustained Cell Engraftment of Donor Cells | 1 year | Sustained stem cell engraftment of donor cells will be evaluated by chimerism (FISH fluorescence in situ hybridization OR VNTR (Variable Number of Tandem Repeats), based on recipient/donor gender, at 30 days, 100 days, 6 months and 1 year following the use of reduced intensity conditioning. |
| Secondary | Assessment of Treatment Related Mortality and Morbidity | 2 years | Patients will be evaluated for incidence and severity of graft versus host disease, infection, and cardiopulmonary complications. |
| Secondary | Event Free Survival; Number of Participants Who Survived at 2 Years | 2 years | 29 participants will be evaluated for Event Free Survival. |
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 With Sustained Cell Engraftment of Donor Cells | 1 year | All 29 participants were analyzed at time-points of 30 days, 100 days, 6 month and 1 year for sustained stem cell engraftment of donor cells. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Assessment of Treatment Related Mortality and Morbidity | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Event Free Survival; Number of Participants Who Survived at 2 Years | 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Sustained Cell Engraftment of Donor Cells | Reduced Intensity Regimen | 29 | Participants | ||
| Assessment of Treatment Related Mortality and Morbidity | Reduced Intensity Regimen | Grade I-Grade III GVHD | 13 | Participants | |
| Assessment of Treatment Related Mortality and Morbidity | Reduced Intensity Regimen | Chronic GVHD | 9 | Participants | |
| Assessment of Treatment Related Mortality and Morbidity | Reduced Intensity Regimen | No complications | 7 | Participants | |
| Event Free Survival; Number of Participants Who Survived at 2 Years | Reduced Intensity Regimen | Expired Secondary to Sepsis | 1 | Participants | |
| Event Free Survival; Number of Participants Who Survived at 2 Years | Reduced Intensity Regimen | Expired Secondary to GVHD | 2 | Participants | |
| Event Free Survival; Number of Participants Who Survived at 2 Years | Reduced Intensity Regimen | Survived Participants | 26 | 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 | Reduced Intensity Regimen | 29 | |
| Overall Study | COMPLETED | Reduced Intensity Regimen | 29 | |
| Overall Study | NOT COMPLETED | Reduced Intensity Regimen | 0 |
Source ClinicalTrials.gov
Adverse events3
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 | Grade I-II Graft vs Host Disease | Immune system disorders | Reduced Intensity Regimen | 13 | 29 | |
| serious | Graft vs Host Disease | Gastrointestinal disorders | Reduced Intensity Regimen | 2 | 29 | 2 |
| serious | Sepsis | Infections and infestations | Reduced Intensity Regimen | 1 | 29 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Reduced Intensity Regimen | 3 | 29 |
| Total, other adverse events | Reduced Intensity Regimen | 13 | 29 |
| Total, serious adverse events | Reduced Intensity Regimen | 3 | 29 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26348869 | DERIVED |
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/NCT02435901
GET https://conductscience.org/api/trials/v1/NCT02435901/registered