Trial · NCT00950846
Umbilical Cord Blood Transplant for Congenital Pediatric Disorders
NCT00950846, Not applicable, Completed, Baylor College of Medicine; results first posted 2023-10-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Umbilical Cord Blood Transplant for Congenital Pediatric Disorders. Trials, record NCT00950846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00950846
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Umbilical Cord Blood Transplant for Congenital Pediatric Disorders
- NCT number
- NCT00950846
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 40 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Congenital Pediatric Disorders
- Interventions
- Busulfan, Cytoxan, Fludarabine, Cord Blood Stem Cell Infusion
- First posted
- 2009-08-03
- Last updated
- 2023-10-30
- Results first posted
- 2023-10-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival at 100 Days After Umbilical Cord Blood Transplant in Pediatric Patients. | 100 days | To determine the overall survival rate at 100 days after umbilical cord blood transplant in pediatric patients with myeloid hematological malignancies. |
| Primary | Overall Survival at 1 Year After Umbilical Cord Blood Transplant in Pediatric Patients. | 1 year | To determine the overall survival rate at 1 year after umbilical cord blood transplant in pediatric patients with myeloid hematological malignancies. |
| Primary | Overall Survival at 3 Years After Umbilical Cord Blood Transplant in Pediatric Patients. | 3 years | To determine the overall survival rate at 3 years after umbilical cord blood transplant in pediatric patients with myeloid hematological malignancies. |
| Secondary | Number of Participants With Platelet Engraftment | Day 42 | Achievement of untransfused platelet count \> 20 x 10\^9/L on three consecutive days |
| Secondary | Incidence of Severe Grade III-IV Acute GvHD at Day 100. | Day 100 | Number of participants with acute GVHD graded by the method of Przepiorka et al, which evaluates skin involvement, lower and upper GI, and liver function (bilirubin), each being graded in stages from 0 to 4, where 0 means no acute GVHD, and 4 is the highest stage of acute GVHD. |
| Secondary | Number of Participants With Chronic GvHD | 1 year | Number of participants with chronic GVHD graded by the method of Przepiorka et al, which evaluates skin, joints, oral, ocular, hepatic, esophagus, GI, respiratory, platelet, and musculoskeletal involvement, in stages from 0 to 3. |
| Secondary | Number of Participants With Donor Engraftment After Transplant. | 100 days, 6 months and 12 months | To evaluate donor engraftment at 100 days, 6 and 12 months after transplant. |
| Secondary | Number of Participants With Neutrophil Engraftment | Day 42 | Achievement of absolute neutrophil count \> 0.5 x 10\^9/L on three consecutive days |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival at 100 Days After Umbilical Cord Blood Transplant in Pediatric Patients. | 100 days | The analysis included 38 evaluable participants who completed conditioning and received transplants. Two participants were excluded from the analysis. One participant died before receiving transplant and the other was diagnosed with aplastic anemia without signs of malignancy at the time of enrollment, but later showed signs of MDS and progressed to AML, which made the participant not evaluable for this study. | probability of overall survival | NUMBER |
| PRIMARY | Overall Survival at 1 Year After Umbilical Cord Blood Transplant in Pediatric Patients. | 1 year | The analysis included 38 evaluable participants who completed conditioning and received transplants. Two participants were excluded from the analysis. One participant died before receiving transplant and the other was diagnosed with aplastic anemia without signs of malignancy at the time of enrollment, but later showed signs of MDS and progressed to AML, which made the participant not evaluable for this study. | probability of overall survival | NUMBER |
| PRIMARY | Overall Survival at 3 Years After Umbilical Cord Blood Transplant in Pediatric Patients. | 3 years | The analysis included 38 evaluable participants who completed conditioning and received transplants. Two participants were excluded from the analysis. One participant died before receiving transplant and the other was diagnosed with aplastic anemia without signs of malignancy at the time of enrollment, but later showed signs of MDS and progressed to AML, which made the participant not evaluable for this study. | probability of overall survival | NUMBER |
| SECONDARY | Number of Participants With Platelet Engraftment | Day 42 | The analysis included 37 evaluable participants who completed conditioning, received transplants and were alive on day 42. Three participants were excluded from the analysis. One participant died before receiving transplant, one was not evaluable due to possible undiagnosed AML at study entry, and one died on day 31 after transplant. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Severe Grade III-IV Acute GvHD at Day 100. | Day 100 | The analysis included all participants who received transplants and were evaluable for acute GVHD. One participant was not evaluable due to possible undiagnosed AML at study entry and all other participants who received transplants were evaluable for acute GVHD if he/she engrafted and either completed 100 days observation after transplant or experienced acute GVHD. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Chronic GvHD | 1 year | The analysis included all participants who received transplants and were evaluable for chronic GVHD. One participant was not evaluable due to possible undiagnosed AML at study entry and all other participants who received transplants were evaluable for chronic GVHD if he/she engrafted and survived or remained in the study for more than 101 days after transplant. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Donor Engraftment After Transplant. | 100 days, 6 months and 12 months | The analysis included all participants who underwent transplant and were evaluable at the time of assessments. One participant was not evaluable due to possible undiagnosed AML at study entry. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Neutrophil Engraftment | Day 42 | The analysis included 37 evaluable participants who completed conditioning, received transplants and were alive on day 42. Three participants were excluded from the analysis. One participant died before receiving transplant, one was not evaluable due to possible undiagnosed AML at study entry, and one died on day 31 after transplant. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival at 100 Days After Umbilical Cord Blood Transplant in Pediatric Patients. | Umbilical Cord Blood Transplant Treatment Plan | 0.947 | 95% Confidence Interval 0.806 to 0.987 | probability of overall survival | |
| Overall Survival at 1 Year After Umbilical Cord Blood Transplant in Pediatric Patients. | Umbilical Cord Blood Transplant Treatment Plan | 0.868 | 95% Confidence Interval 0.712 to 0.943 | probability of overall survival | |
| Overall Survival at 3 Years After Umbilical Cord Blood Transplant in Pediatric Patients. | Umbilical Cord Blood Transplant Treatment Plan | 0.868 | 95% Confidence Interval 0.712 to 0.943 | probability of overall survival | |
| Number of Participants With Platelet Engraftment | Umbilical Cord Blood Transplant Treatment Plan | Engrafted | 17 | Participants | |
| Number of Participants With Platelet Engraftment | Umbilical Cord Blood Transplant Treatment Plan | Not engrafted | 20 | Participants | |
| Incidence of Severe Grade III-IV Acute GvHD at Day 100. | Umbilical Cord Blood Transplant Treatment Plan | 1 | Participants | ||
| Number of Participants With Chronic GvHD | Umbilical Cord Blood Transplant Treatment Plan | 1 | Participants | ||
| Number of Participants With Donor Engraftment After Transplant. | Umbilical Cord Blood Transplant Treatment Plan | 100 days | 36 | Participants | |
| Number of Participants With Donor Engraftment After Transplant. | Umbilical Cord Blood Transplant Treatment Plan | 6 months | 33 | Participants | |
| Number of Participants With Donor Engraftment After Transplant. | Umbilical Cord Blood Transplant Treatment Plan | 12 months | 33 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Umbilical Cord Blood Transplant Treatment Plan | 40 | |
| Overall Study | COMPLETED | Umbilical Cord Blood Transplant Treatment Plan | 30 | |
| Overall Study | NOT COMPLETED | Umbilical Cord Blood Transplant Treatment Plan | 10 |
Source ClinicalTrials.gov
Adverse events66
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 | Aspartate aminotransferase increased | Investigations | Umbilical Cord Blood Transplant Treatment Plan | 2 | 40 | 3 |
| other | Bicarbonate, serum-low | Investigations | Umbilical Cord Blood Transplant Treatment Plan | 1 | 40 | 1 |
| other | Blood bilirubin increased | Infections and infestations | Umbilical Cord Blood Transplant Treatment Plan | 4 | 40 | 4 |
| other | Calcium, serum-low (hypocalcemia) | Investigations | Umbilical Cord Blood Transplant Treatment Plan | 1 | 40 | 1 |
| other | Catheter related infection | Gastrointestinal disorders | Umbilical Cord Blood Transplant Treatment Plan | 6 | 40 | 7 |
| other | Creatinine increased | Respiratory, thoracic and mediastinal disorders | Umbilical Cord Blood Transplant Treatment Plan | 1 | 40 | 1 |
| other | Diarrhea | Metabolism and nutrition disorders | Umbilical Cord Blood Transplant Treatment Plan | 2 | 40 | 5 |
| other | Dyspnea | Metabolism and nutrition disorders | Umbilical Cord Blood Transplant Treatment Plan | 1 | 40 | 1 |
| other | Fibrinogen | Vascular disorders | Umbilical Cord Blood Transplant Treatment Plan | 1 | 40 | 1 |
| other | Hematuria | Metabolism and nutrition disorders | Umbilical Cord Blood Transplant Treatment Plan | 1 | 40 | 1 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Umbilical Cord Blood Transplant Treatment Plan | 6 | 40 |
| Total, other adverse events | Umbilical Cord Blood Transplant Treatment Plan | 25 | 40 |
| Total, serious adverse events | Umbilical Cord Blood Transplant Treatment Plan | 27 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36453638 | 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/NCT00950846
GET https://conductscience.org/api/trials/v1/NCT00950846/events?page=2