Trial · NCT00309842
Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases
NCT00309842, Phase 2, Completed, Masonic Cancer Center, University of Minnesota; results first posted 2020-09-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases. Trials, record NCT00309842. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00309842
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases
- NCT number
- NCT00309842
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 213 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelofibrosis, MDS, Refractory Anemia, Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Non-Hodgkin's Lymphoma, Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndromes
- Interventions
- filgrastim, cyclophosphamide, cyclosporine, fludarabine phosphate, mycophenolate mofetil, umbilical cord blood transplantation, total-body irradiation
- First posted
- 2006-04-03
- Last updated
- 2020-09-10
- Results first posted
- 2020-09-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Were Alive at 1 Year Transplant Overall Survival | at 1 year | Number of patients alive at 1 year after transplant. |
| Secondary | Number of Participants Who Died Due to Transplant | At Month 6 | Determine the incidence of transplant-related mortality at 6 months after UCBT |
| Secondary | Number of Participants With Platelet Engraftment | 6 months | Determine the incidence of platelet engraftment (platelet recovery \>50,000/uL) at 6 months after UCBT. |
| Secondary | Number of Participants With Neutrophil Engraftment | Day 42 | Determine the incidence of neutrophil engraftment at day 42 after UCBT Patients diagnosed with graft failure (failure of absolute neutrophil count ANC \> 5 x 10\^8/L of donor origin by day +42) |
| Secondary | Number of Participants With Acute Graft-Versus-Host Disease | Day 100 | Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria following Przepiorka et al, 1995, Consensus Clinical Stage and Grade of Acute GVHD. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. |
| Secondary | Number of Participants With Chronic Graft-Versus-Host Disease | Year 1 | Determine the incidence of chronic GVHD at 1 year after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. |
| Secondary | Percentage Chimerism on Day 21 | Day 21 | Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. |
| Secondary | Percentage Chimerism on Day 100 | Day 100 | Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. |
| Secondary | Percentage Chimerism at 6 Months | Month 6 | Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. |
| Secondary | Percentage Chimerism at 1 Year | 1 Year | Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Were Alive at 1 Year Transplant Overall Survival | at 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Died Due to Transplant | At Month 6 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Platelet Engraftment | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Neutrophil Engraftment | Day 42 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Acute Graft-Versus-Host Disease | Day 100 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Chronic Graft-Versus-Host Disease | Year 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage Chimerism on Day 21 | Day 21 | percentage of donor cells | MEAN | |
| SECONDARY | Percentage Chimerism on Day 100 | Day 100 | percentage of donor cells | MEAN | |
| SECONDARY | Percentage Chimerism at 6 Months | Month 6 | percentage of donor cells | MEAN | |
| SECONDARY | Percentage Chimerism at 1 Year | 1 Year | percentage of donor cells | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Were Alive at 1 Year Transplant Overall Survival | Unrelated UCBT for Blood Cancers | 130 | Participants | ||
| Number of Participants Who Died Due to Transplant | Unrelated UCBT for Blood Cancers | 58 | Participants | ||
| Number of Participants With Platelet Engraftment | Unrelated UCBT for Blood Cancers | 159 | Participants | ||
| Number of Participants With Neutrophil Engraftment | Unrelated UCBT for Blood Cancers | 21 | Participants | ||
| Number of Participants With Acute Graft-Versus-Host Disease | Unrelated UCBT for Blood Cancers | Grade II-IV | 106 | Participants | |
| Number of Participants With Acute Graft-Versus-Host Disease | Unrelated UCBT for Blood Cancers | Grade III-IV | 49 | Participants | |
| Number of Participants With Chronic Graft-Versus-Host Disease | Unrelated UCBT for Blood Cancers | 39 | Participants | ||
| Percentage Chimerism on Day 21 | Unrelated UCBT for Blood Cancers | 92.6 | Standard Deviation 14.9 | percentage of donor cells | |
| Percentage Chimerism on Day 100 | Unrelated UCBT for Blood Cancers | 98.1 | Standard Deviation 8.5 | percentage of donor cells | |
| Percentage Chimerism at 6 Months | Unrelated UCBT for Blood Cancers | 98.1 | Standard Deviation 11.3 | percentage of donor cells |
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 | Unrelated UCBT for Blood Cancers | 213 | |
| Overall Study | COMPLETED | Unrelated UCBT for Blood Cancers | 212 | |
| Overall Study | NOT COMPLETED | Unrelated UCBT for Blood Cancers | 1 |
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 | Multi organ failure | General disorders | Unrelated UCBT for Blood Cancers | 12 | 212 | 13 |
| other | Hemorrhage | Blood and lymphatic system disorders | Unrelated UCBT for Blood Cancers | 12 | 212 | 14 |
| other | Neurotoxicity | Nervous system disorders | Unrelated UCBT for Blood Cancers | 13 | 212 | 14 |
| other | Neuropathy | Nervous system disorders | Unrelated UCBT for Blood Cancers | 16 | 212 | 16 |
| other | Acute kidney injury | Renal and urinary disorders | Unrelated UCBT for Blood Cancers | 18 | 212 | 18 |
| other | GI bleeding | Gastrointestinal disorders | Unrelated UCBT for Blood Cancers | 18 | 212 | 19 |
| other | Hypertension | Vascular disorders | Unrelated UCBT for Blood Cancers | 62 | 212 | 62 |
| other | Veno-Occlusive Disease (VOD) | Hepatobiliary disorders | Unrelated UCBT for Blood Cancers | 12 | 212 | 19 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Unrelated UCBT for Blood Cancers | 22 | 212 | 22 |
| other | Dialysis | Renal and urinary disorders | Unrelated UCBT for Blood Cancers | 23 | 212 | 23 |
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 | Unrelated UCBT for Blood Cancers | 161 | 212 |
| Total, other adverse events | Unrelated UCBT for Blood Cancers | 187 | 212 |
| Total, serious adverse events | Unrelated UCBT for Blood Cancers | 92 | 212 |
Source ClinicalTrials.gov
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/NCT00309842
GET https://conductscience.org/api/trials/v1/NCT00309842/events?page=2