Trial · NCT01962415
Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT
NCT01962415, Phase 2, Recruiting, Paul Szabolcs
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT. Trials, record NCT01962415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01962415
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT
- NCT number
- NCT01962415
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Paul Szabolcs
- Conditions
Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias, Inflammatory Conditions, Systemic Juvenile Idiopathic Arthritis (sJIA), Juvenile Rheumatoid Arthritis (JRA)
- Interventions
- Hydroxyurea, Alemtuzumab, Fludarabine, Melphalan, Thiotepa
- First posted
- 2013-10-14
- Last updated
- 2025-12-15
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-transplant treatment-related mortality (TRM) | 1 year post-transplant | The number of deaths related to the research intervention at day 100, 6 months, and 1 year post-transplant. |
| Primary | Neurodevelopmental milestones | 1 year post-transplant | Evaluation of the pace of attaining neurodevelopmental milestones after reduced-intensity conditioning as compared to myeloablative conditioning historical controls from the target population(s). |
| Primary | Immune Reconstitution | 1 year post-transplant | Evaluation of the pace of immune reconstitution. |
| Primary | Severe opportunistic infections | 1 year post-transplant | Evaluation of the incidence of severe opportunistic infections. |
| Primary | GVHD occurrence | 1 year post-transplant | Description of the incidence of acute graft versus host disease (GVHD) (II-IV) and chronic extensive GVHD. |
| Secondary | Donor cell engraftment | 6 months post-transplant | Determination of the feasibility of attaining robust donor cell engraftment (\>50% donor chimerism at 6 months) following reduced-intensity conditioning (RIC) regimens prior to HSCT in the target population(s). |
| Secondary | Normal enzyme level | 1 year post-transplant | Determination of the feasibility of attaining and sustaining normal enzyme levels in the target population(s). |
| Secondary | Neutrophil recovery | 1 year post-transplant | Determination of the pace of neutrophil recovery. |
| Secondary | Platelet recovery | 1 year post-transplant | Determination of the pace of platelet recovery. |
| Secondary | Grade 3-4 organ toxicity | 1 year post-transplant | The number of grade 3-4 organ adverse events. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01962415
GET https://conductscience.org/api/trials/v1/NCT01962415/registered