Trial · NCT00638820
Reduced Intensity AlloTransplant For Osteopetrosis
NCT00638820, Phase 2, Terminated, Masonic Cancer Center, University of Minnesota; results first posted 2010-02-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Reduced Intensity AlloTransplant For Osteopetrosis. Trials, record NCT00638820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00638820
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reduced Intensity AlloTransplant For Osteopetrosis
- NCT number
- NCT00638820
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Osteopetrosis
- Interventions
- Stem Cell or Umbilical Cord Blood Transplantation, Campath, Busulfan, Clofarabine, Total Lymphoid Irradiation
- First posted
- 2008-03-19
- Last updated
- 2017-12-28
- Results first posted
- 2010-02-03
- Limitations and caveats
Only 3 participants were treated in this study; all died by Day 100. Data for both treatment arms were combined due to low number. (Arm 1 utilized mobilized peripheral blood or marrow (related or unrelated). Arm 2 received cord blood transplants).
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Achieving Donor Cell Engraftment | Day 100 | Number of patients with persistent presence of donor-derived cells at Day 100 |
| Secondary | Number of Patients With Transplant Related Death | Day 100 | Number of participants died during study by Day 100 and reason for death was related to transplant. |
| Secondary | Number of Patients With Transplant Related Toxicity | Day 100 | Number of patients experiencing adverse effects due to transplant categorized by body system using Common Terminology Criteria for Adverse Events coding from the National Cancer Institute, Version 3.0. |
| Secondary | Differential Imaging and Biologic Evaluations | Day 100, 6 months, 1, 2 and 5 years | These outcome measures were not assessed due to early study termination. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Achieving Donor Cell Engraftment | Day 100 | Participants | NUMBER | |
| SECONDARY | Number of Patients With Transplant Related Death | Day 100 | Participants | NUMBER | |
| SECONDARY | Number of Patients With Transplant Related Toxicity | Day 100 | Participants | NUMBER | |
| SECONDARY | Differential Imaging and Biologic Evaluations | Day 100, 6 months, 1, 2 and 5 years |
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 Patients Achieving Donor Cell Engraftment | Patients With Osteopetrosis Who Received Transplant | 2 | Participants | ||
| Number of Patients With Transplant Related Death | Patients With Osteopetrosis Who Received Transplant | 3 | Participants | ||
| Number of Patients With Transplant Related Toxicity | Patients With Osteopetrosis Who Received Transplant | Neurologic | 1 | Participants | |
| Number of Patients With Transplant Related Toxicity | Patients With Osteopetrosis Who Received Transplant | Renal | 1 | Participants | |
| Number of Patients With Transplant Related Toxicity | Patients With Osteopetrosis Who Received Transplant | Pulmonary | 3 | Participants | |
| Number of Patients With Transplant Related Toxicity | Patients With Osteopetrosis Who Received Transplant | Peri-Transplant Mortality (Death by Day 100) | 3 | Participants | |
| Number of Patients With Transplant Related Toxicity | Patients With Osteopetrosis Who Received Transplant | Vascular | 1 | 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 | Patients With Osteopetrosis Who Received Transplant | 3 | |
| Overall Study | COMPLETED | Patients With Osteopetrosis Who Received Transplant | 3 | |
| Overall Study | NOT COMPLETED | Patients With Osteopetrosis Who Received Transplant | 0 |
Source ClinicalTrials.gov
Adverse events5
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 | Neurologic | Nervous system disorders | Patients With Osteopetrosis Who Received Transplant | 1 | 3 | 1 |
| other | Renal | Renal and urinary disorders | Patients With Osteopetrosis Who Received Transplant | 1 | 3 | 1 |
| other | Pulmonary | Respiratory, thoracic and mediastinal disorders | Patients With Osteopetrosis Who Received Transplant | 3 | 3 | 3 |
| other | Vascular | Vascular disorders | Patients With Osteopetrosis Who Received Transplant | 1 | 3 | 1 |
| serious | Death, peri-transplant | General disorders | Patients With Osteopetrosis Who Received Transplant | 3 | 3 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients With Osteopetrosis Who Received Transplant | ||
| Total, other adverse events | Patients With Osteopetrosis Who Received Transplant | 3 | 3 |
| Total, serious adverse events | Patients With Osteopetrosis Who Received Transplant | 3 | 3 |
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/NCT00638820
GET https://conductscience.org/api/trials/v1/NCT00638820/registered