Trial · NCT00763490
Trial Of Double Umbilical Cord Blood Transplantation
NCT00763490, Phase 2, Completed, University of Michigan Rogel Cancer Center; results first posted 2015-01-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial Of Double Umbilical Cord Blood Transplantation. Trials, record NCT00763490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00763490
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial Of Double Umbilical Cord Blood Transplantation
- NCT number
- NCT00763490
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Conditions
- Hematological Malignancies
- Interventions
Full intensity, double umbilical cord, stem cell transplant, Flu/Bu4 conditioning regimen, Total Lymphoid Irradiation (TLI), Graft versus Host Disease prevention (GVHD prophylaxis), Mycophenolate Mofetil
- First posted
- 2008-10-01
- Last updated
- 2016-12-23
- Results first posted
- 2015-01-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Alive at 1 Year After Transplant | 1 year | One-year survival rate after transplant |
| Secondary | Percentage of Patients Alive at the End of the Trial | 5 Years | Event Free Survival (EFS) was determined. Patients were followed up to 5 years (median time of 2.35 years). |
| Secondary | Cumulative Incidence of Neutrophil and Platelet Engraftment | Day 35 | The failure to achieve a neutrophil count \> 500/uL or a platelet count \>30.0 x 10e9 /L within 35 days of the stem cell infusion will be defined as primary engraftment failure. |
| Secondary | Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD) | Up to 5 years | The percentage of patients with acute GVHD (Grade II-IV) was determined at 100 days. Patients were followed up to 5 years and the percentage of patients that developed chronic GVHD at the end of the study was tabulated. Acute GVHD is staged and graded (grade 0-IV, where grade 0 is no involvement and involvement increases by grade) by the number and extent of organ involvement. Patients can have involvement of three organs: skin (rash/dermatitis), liver (hepatitis/jaundice), and gastrointestinal tract (abdominal pain/diarrhea). |
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 | Percentage of Participants Alive at 1 Year After Transplant | 1 year | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Patients Alive at the End of the Trial | 5 Years | percentage of patients | NUMBER | |
| SECONDARY | Cumulative Incidence of Neutrophil and Platelet Engraftment | Day 35 | percentage of participants | NUMBER | |
| SECONDARY | Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD) | Up to 5 years | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Alive at 1 Year After Transplant | Double Cord Blood Tranplant | 40 | 95% Confidence Interval 19 to 60 | percentage of participants | |
| Percentage of Patients Alive at the End of the Trial | Double Cord Blood Tranplant | 35 | 95% Confidence Interval 16 to 55 | percentage of patients | |
| Cumulative Incidence of Neutrophil and Platelet Engraftment | Double Cord Blood Tranplant | Cumulative incidence of platlet engraftment | 73 | 95% Confidence Interval 48 to 88 | percentage of participants |
| Cumulative Incidence of Neutrophil and Platelet Engraftment | Double Cord Blood Tranplant | Cumulative incidence of neutrophil engraftment | 89 | 95% Confidence Interval 64 to 97 | percentage of participants |
| Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD) | Double Cord Blood Tranplant | Acute GVHD (Grades II-IV) | 40 | 95% Confidence Interval 19 to 60 | percentage of patients |
| Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD) | Double Cord Blood Tranplant | Chronic GVHD | 35 | 95% Confidence Interval 16 to 65 | percentage of patients |
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 | Double Cord Blood Tranplant | 20 | |
| Overall Study | COMPLETED | Double Cord Blood Tranplant | 20 | |
| Overall Study | NOT COMPLETED | Double Cord Blood Tranplant | 0 |
Source ClinicalTrials.gov
Adverse events29
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 | Blood/Bone Marrow - Other | Blood and lymphatic system disorders | Double Cord Blood Tranplant | 3 | 20 | 3 |
| other | Hypertension | Cardiac disorders | Double Cord Blood Tranplant | 2 | 20 | 2 |
| other | Hypotension | Cardiac disorders | Double Cord Blood Tranplant | 6 | 20 | 6 |
| other | Weight gain | Investigations | Double Cord Blood Tranplant | 2 | 20 | 3 |
| other | Pruritus/itching | Skin and subcutaneous tissue disorders | Double Cord Blood Tranplant | 2 | 20 | 2 |
| other | Anorexia | Gastrointestinal disorders | Double Cord Blood Tranplant | 3 | 20 | 3 |
| other | Heartburn/dyspepsia | Gastrointestinal disorders | Double Cord Blood Tranplant | 2 | 20 | 2 |
| other | Hemorrhage, pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | Double Cord Blood Tranplant | 2 | 20 | 2 |
| other | Infection with normal ANC | Infections and infestations | Double Cord Blood Tranplant | 3 | 20 | 3 |
| other | Confusion | Nervous system disorders | Double Cord Blood Tranplant | 4 | 20 | 4 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double Cord Blood Tranplant | ||
| Total, other adverse events | Double Cord Blood Tranplant | 8 | 20 |
| Total, serious adverse events | Double Cord Blood Tranplant | 14 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25046834 | 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/NCT00763490
GET https://conductscience.org/api/trials/v1/NCT00763490/events?page=2