Trial · NCT00412360
Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501)
NCT00412360, Phase 3, Completed, Medical College of Wisconsin; results first posted 2015-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501). Trials, record NCT00412360. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00412360
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501)
- NCT number
- NCT00412360
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 224 participants, actual
- Lead sponsor
- Medical College of Wisconsin
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome, Natural Killer Cell Lymphoblastic Leukemia/Lymphoma
- Interventions
- Single Umbilical Cord Blood Unit Transplant, Double Umbilical Cord Blood Unit Transplant, Total Body Irradiation, Cyclophosphamide, Fludarabine, Cyclosporine A, Mycophenolate Mofetil
- First posted
- 2006-12-18
- Last updated
- 2021-10-28
- Results first posted
- 2015-12-21
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Overall Survival | 1 year post-randomization | Overall survival is defined as survival of death from any cause. |
| Secondary | Percentage of Participants With Disease-free Survival | 1 year post-randomization | Disease-free survival is defined as survival without relapse of the primary disease. |
| Secondary | Percentage of Participants With Neutrophil and Platelet Engraftment | Days 42 and 100 | Neutrophil engraftment is defined as achieving an absolute neutrophil count greater than 500x10\^6/liter for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil engraftment. Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days. |
| Secondary | Time to Neutrophil and Platelet Engraftment | 2 years post-transplant | Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days. |
| Secondary | Percentage of Participants With Acute Graft-versus-host Disease (GVHD) | Day 100 post-randomization | Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995: Skin stage: 0: No rash 1. Rash \<25% of body surface area 2. Rash on 25-50% of body surface area 3. Rash on \> 50% of body surface area 4. Generalized erythroderma with bullous formation Liver stage (based on bilirubin level)\*: 0: \<2 mg/dL 1. 2-3 mg/dL 2. 3.01-6 mg/dL 3. 6.01-15.0 mg/dL 4. \>15 mg/dL GI stage\*: 0: No diarrhea or diarrhea \<500 mL/day 1. Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD 2. Diarrhea 1000-1499 mL/day 3. Diarrhea \>1500 mL/day 4. Severe abdominal pain with or without ileus \* If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1. GVHD grade: 0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4 |
| Secondary | Percentage of Participants With Chronic GVHD | 1 year post-randomization | Incidences of chronic GVHD will be graded per Shulman et al. 1980. This reference categorizes chronic GVHD as either limited or extensive. For this outcome, participants developing either type are considered to have a chronic GVHD event. |
| Secondary | Number of Infections Per Participant | 2 years post-randomization | |
| Secondary | Percentage of Participants With Relapse | 1 year post-randomization | Relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, or MDS consistent with pre-transplant features. Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. |
| Secondary | Percentage of Participants With Treatment-related Mortality | 1 year post-randomization | Treatment related mortality is defined as death without relapse of the primary disease. |
| Secondary | Number of Participants With Engraftment Syndrome | Day 100 post-transplant |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Overall Survival | 1 year post-randomization | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Disease-free Survival | 1 year post-randomization | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Neutrophil and Platelet Engraftment | Days 42 and 100 | Transplanted participants | percentage of participants | NUMBER |
| SECONDARY | Time to Neutrophil and Platelet Engraftment | 2 years post-transplant | Transplanted participants | days | MEDIAN |
| SECONDARY | Percentage of Participants With Acute Graft-versus-host Disease (GVHD) | Day 100 post-randomization | Transplanted participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Chronic GVHD | 1 year post-randomization | Transplanted participants | percentage of participants | NUMBER |
| SECONDARY | Number of Infections Per Participant | 2 years post-randomization | Transplanted participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Relapse | 1 year post-randomization | Transplanted participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-related Mortality | 1 year post-randomization | Transplanted participants | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Engraftment Syndrome | Day 100 post-transplant | Transplanted participants | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Overall Survival | Single UCB Transplant | 73 | 95% Confidence Interval 63 to 80 | percentage of participants | |
| Percentage of Participants With Overall Survival | Double UCB Transplant | 65 | 95% Confidence Interval 56 to 74 | percentage of participants | |
| Percentage of Participants With Disease-free Survival | Single UCB Transplant | 70 | 95% Confidence Interval 60 to 77 | percentage of participants | |
| Percentage of Participants With Disease-free Survival | Double UCB Transplant | 64 | 95% Confidence Interval 54 to 72 | percentage of participants | |
| Percentage of Participants With Neutrophil and Platelet Engraftment | Single UCB Transplant | Neutrophil Engraftment at Day 42 | 89 | 95% Confidence Interval 83 to 95 | percentage of participants |
| Percentage of Participants With Neutrophil and Platelet Engraftment | Double UCB Transplant | Neutrophil Engraftment at Day 42 | 88 | 95% Confidence Interval 82 to 94 | percentage of participants |
| Percentage of Participants With Neutrophil and Platelet Engraftment | Single UCB Transplant | Platelet Engraftment at Day 100 | 76 | 95% Confidence Interval 68 to 85 | percentage of participants |
| Percentage of Participants With Neutrophil and Platelet Engraftment | Double UCB Transplant | Platelet Engraftment at Day 100 | 65 | 95% Confidence Interval 56 to 74 | percentage of participants |
| Time to Neutrophil and Platelet Engraftment | Single UCB Transplant | Neutrophil Engraftment | 21 | Full Range 11 to 62 | days |
| Time to Neutrophil and Platelet Engraftment | Double UCB Transplant | Neutrophil Engraftment | 23 | Full Range 11 to 133 | days |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single UCB Transplant | 113 | |
| Overall Study | STARTED | Double UCB Transplant | 111 | |
| Overall Study | COMPLETED | Single UCB Transplant | 112 | |
| Overall Study | COMPLETED | Double UCB Transplant | 108 | |
| Overall Study | NOT COMPLETED | Single UCB Transplant | 1 | |
| Overall Study | NOT COMPLETED | Double UCB Transplant | 3 |
Source ClinicalTrials.gov
Adverse events30
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 |
|---|---|---|---|---|---|---|
| serious | Hemolytic anemia | Blood and lymphatic system disorders | Single UCB Transplant | 0 | 112 | 0 |
| serious | Hemolytic anemia | Blood and lymphatic system disorders | Double UCB Transplant | 2 | 108 | 2 |
| serious | Congestive heart failure | Cardiac disorders | Single UCB Transplant | 1 | 112 | 1 |
| serious | Congestive heart failure | Cardiac disorders | Double UCB Transplant | 1 | 108 | 1 |
| serious | Abdominal pain | Gastrointestinal disorders | Single UCB Transplant | 0 | 112 | 0 |
| serious | Abdominal pain | Gastrointestinal disorders | Double UCB Transplant | 1 | 108 | 1 |
| serious | Pneumonia | Infections and infestations | Single UCB Transplant | 0 | 112 | 0 |
| serious | Pneumonia | Infections and infestations | Double UCB Transplant | 1 | 108 | 1 |
| serious | Hyperglycemia | Metabolism and nutrition disorders | Single UCB Transplant | 2 | 112 | 2 |
| serious | Hyperglycemia | Metabolism and nutrition disorders | Double UCB Transplant | 0 | 108 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single UCB Transplant | ||
| Total, all-cause mortality | Double UCB Transplant | ||
| Total, other adverse events | Single UCB Transplant | 0 | 112 |
| Total, other adverse events | Double UCB Transplant | 0 | 108 |
| Total, serious adverse events | Single UCB Transplant | 5 | 112 |
| Total, serious adverse events | Double UCB Transplant | 14 | 108 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U24CA076518 | A Data Resource for Blood and Marrow Transplants and Adoptive Cellular Therapy Research | SHAW, BRONWEN; MOSKOP, AMY M | MEDICAL COLLEGE OF WISCONSIN | NATIONAL CANCER INSTITUTE | 1998 to 2025 | NIH RePORTER |
| U01HL069294 | BMT Clinical Research Network Data Coordinating Center | HOROWITZ, MARY MARESCA | MEDICAL COLLEGE OF WISCONSIN | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Single UCB Transplant vs Double UCB Transplant: Number of Participants With Engraftment Syndrome | Trial comparisons |
| Single UCB Transplant vs Double UCB Transplant: serious adverse events | Trial comparisons |
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/NCT00412360
GET https://conductscience.org/api/trials/v1/NCT00412360/results?page=2