Trial · NCT00176930
Stem Cell Transplant for Hematological Malignancy
NCT00176930, Not applicable, Terminated, Masonic Cancer Center, University of Minnesota; results first posted 2021-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stem Cell Transplant for Hematological Malignancy. Trials, record NCT00176930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00176930
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stem Cell Transplant for Hematological Malignancy
- NCT number
- NCT00176930
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 330 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Leukemia, Myeloid, Chronic, AML, Leukemia, Lymphocytic, Acute, MDS, Leukemia, Lymphocytic, Chronic, JMML, Hodgkin's Disease, Non-hodgkin's Lymphoma, Multiple Myeloma
- Interventions
- Stem Cell Transplant, Cyclophosphamide, Total Body Irradiation, Busulfan, Equine ATG (ATGAM), CD4+/CD25+ cells
- First posted
- 2005-09-15
- Last updated
- 2021-01-22
- Results first posted
- 2021-01-22
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | 2 years | Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working. |
| Primary | Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant | 5 years | Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working. |
| Secondary | Number of Participants With Neutrophil Engraftment | Day 42 | Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm\^3 (0.5 x 10\^9/L) or greater. |
| Secondary | Number of Participants With Acute Graft-versus-host Disease (GVHD) | Day 100 | Acute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host. Determine the incidence of grade II-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. 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 | 1 year | Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Determine the incidence of chronic GVHD 1 year post transplant. 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 | Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant | 2 years | Defined as the return of disease after its apparent recovery/cessation. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. |
| Secondary | Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant | 5 years | Defined as the return of disease after its apparent recovery/cessation. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. |
| Secondary | Number of Participants Who Were Alive at 2 Year Post Transplant | 2 years | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. |
| Secondary | Number of Participants Who Were Alive at 5 Year Post Transplant | 5 years | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. |
| Secondary | Number of Participants Experiencing Engraftment Failure | Day 42 | Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets. |
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 | Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant | 5 years | 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 (GVHD) | Day 100 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Chronic Graft-Versus-Host Disease | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant | 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Were Alive at 2 Year Post Transplant | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Were Alive at 5 Year Post Transplant | 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Engraftment Failure | Day 42 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | PBSC: No TBI | 4 | Participants | ||
| Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | Marrow : No TBI | 9 | Participants | ||
| Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | UCB : No TBI | 0 | Participants | ||
| Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | UCB : No TBI/Bu/Cy/ATG | 0 | Participants | ||
| Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | PBSC | 100 | Participants | ||
| Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | Marrow | 52 | Participants | ||
| Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | Umbilical Cord Blood | 2 | Participants | ||
| Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | Co-Enroll From MT0403 | 2 | Participants | ||
| Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant | PBSC: No TBI | 3 | Participants | ||
| Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant | Marrow : No TBI | 9 | Participants |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PBSC: No TBI | 12 | |
| Overall Study | STARTED | Marrow : No TBI | 13 | |
| Overall Study | STARTED | UCB : No TBI | 1 | |
| Overall Study | STARTED | UCB : No TBI/Bu/Cy/ATG | 1 | |
| Overall Study | STARTED | PBSC | 213 | |
| Overall Study | STARTED | Marrow | 85 | |
| Overall Study | STARTED | Umbilical Cord Blood | 2 | |
| Overall Study | STARTED | Co-Enroll From MT0403 | 2 | |
| Overall Study | COMPLETED | PBSC: No TBI | 12 | |
| Overall Study | COMPLETED | Marrow : No TBI | 13 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events208
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 | Infection | Infections and infestations | PBSC: No TBI | 10 | 12 | 37 |
| other | Infection | Infections and infestations | Marrow : No TBI | 9 | 13 | 32 |
| other | Infection | Infections and infestations | UCB : No TBI | 1 | 1 | 6 |
| other | Infection | Infections and infestations | UCB : No TBI/Bu/Cy/ATG | 1 | 1 | 4 |
| other | Infection | Infections and infestations | PBSC | 114 | 213 | 375 |
| other | Infection | Infections and infestations | Marrow | 54 | 85 | 169 |
| other | Infection | Infections and infestations | Umbilical Cord Blood | 1 | 2 | 2 |
| other | Infection | Infections and infestations | Co-Enroll From MT0403 | 0 | 2 | 0 |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | PBSC: No TBI | 5 | 12 | 14 |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Marrow : No TBI | 6 | 13 | 8 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PBSC: No TBI | 9 | 12 |
| Total, all-cause mortality | Marrow : No TBI | 4 | 13 |
| Total, all-cause mortality | UCB : No TBI | 1 | 1 |
| Total, all-cause mortality | UCB : No TBI/Bu/Cy/ATG | 1 | 1 |
| Total, all-cause mortality | PBSC | 113 | 213 |
| Total, all-cause mortality | Marrow | 31 | 85 |
| Total, all-cause mortality | Umbilical Cord Blood | 0 | 2 |
| Total, all-cause mortality | Co-Enroll From MT0403 | 0 | 2 |
| Total, other adverse events | PBSC: No TBI | 12 | 12 |
| Total, other adverse events | Marrow : No TBI | 10 | 13 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
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/NCT00176930
GET https://conductscience.org/api/trials/v1/NCT00176930/results?page=2