Trial · NCT00818961
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer
NCT00818961, Phase 2, Terminated, Northside Hospital, Inc.; results first posted 2013-12-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer. Trials, record NCT00818961. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00818961
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer
- NCT number
- NCT00818961
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Northside Hospital, Inc.
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
- Interventions
- alemtuzumab, graft-versus-tumor induction therapy, rituximab, busulfan, cyclophosphamide, fludarabine phosphate, methotrexate, tacrolimus, allogeneic bone marrow transplantation
- First posted
- 2009-01-08
- Last updated
- 2013-12-18
- Results first posted
- 2013-12-18
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival at Day 100 | 100 day | Survival at Day 100 |
| Secondary | Overall Survival at 1 Year | 1 year | Evaluation of overall survival at 1 year (# of patients who are alive at 1 year post-transplant) |
| Secondary | Non-relapse Mortality at Day 100 | Day 100 | patients are evaluable for their cause of death at Day 100 |
| Secondary | Non-relapse Mortality at 1 Year Post-transplant | 1 year | Number of patients who died of non-relapse causes at one year. this is in clusive of all patients who were transplanted on study even though only 10 patients died at by 1 year time point. This outcome will be referenced in the donor chimerism outcome. Only 26/36 patients were eligible for this time point as that is all that were alive. |
| Secondary | Complete Donor Chimerism | 2 years | Complete donor chimerism (defined as \>/= 95% donor cells in peripheral blood CD3+ and CD33+ was measured. |
| Secondary | Neutrophil Recovery | Day 100 | The number of patients experiencing neutrophil recovery post transplant |
| Secondary | Platelet Engraftment | Day 100 | The number of patients experiencing platelet engraftment post-transplant |
| Secondary | Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism | Day 100 | DLI is used for patients with mixed chimerism following transplant |
| Secondary | Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant | patients were followed for 2 years | patients experiencing acute graft versus host disease post-transplant |
| Secondary | Number of Patients Experiencing Chronic Graft Versus Host Disease | >100 days post-transplant |
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 | Survival at Day 100 | 100 day | 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of overall survival at 100 days | participants | NUMBER |
| SECONDARY | Overall Survival at 1 Year | 1 year | 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of overall survival at one year post-transplant | participants | NUMBER |
| SECONDARY | Non-relapse Mortality at Day 100 | Day 100 | 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of non-relapse mortality at Day 100 | participants | NUMBER |
| SECONDARY | Non-relapse Mortality at 1 Year Post-transplant | 1 year | 36 patients underwent hematopoietic stem cell transplant. 10 patients died prior to 1 year post-transplant and were eligible for evaluation of non-relapse mortality at 1 year post-transplant | participants | NUMBER |
| SECONDARY | Complete Donor Chimerism | 2 years | 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of donor chimerism | participants | NUMBER |
| SECONDARY | Neutrophil Recovery | Day 100 | 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of neutrophil recovery | participants | NUMBER |
| SECONDARY | Platelet Engraftment | Day 100 | 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of platelet engraftment. | participants | NUMBER |
| SECONDARY | Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism | Day 100 | 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for donor leukocyte infusions for mixed chimerism following transplant | participants | NUMBER |
| SECONDARY | Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant | patients were followed for 2 years | 36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of acute graft versus host disease post-transplant. | participants | NUMBER |
| SECONDARY | Number of Patients Experiencing Chronic Graft Versus Host Disease | >100 days post-transplant | 35 patients survive past 100 days post-transplant and therefore were eligible for evaluation of chronic graft versus host disease | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival at Day 100 | Hematopoietic Stem Cell Transplantation | 35 | participants | ||
| Overall Survival at 1 Year | Hematopoietic Stem Cell Transplantation | 26 | participants | ||
| Non-relapse Mortality at Day 100 | Hematopoietic Stem Cell Transplantation | 1 | participants | ||
| Non-relapse Mortality at 1 Year Post-transplant | Hematopoietic Stem Cell Transplantation | 4 | participants | ||
| Complete Donor Chimerism | Hematopoietic Stem Cell Transplantation | 26 | participants | ||
| Neutrophil Recovery | Hematopoietic Stem Cell Transplantation | 35 | participants | ||
| Platelet Engraftment | Hematopoietic Stem Cell Transplantation | 35 | participants | ||
| Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism | Hematopoietic Stem Cell Transplantation | 19 | participants | ||
| Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant | Hematopoietic Stem Cell Transplantation | 15 | participants | ||
| Number of Patients Experiencing Chronic Graft Versus Host Disease | Hematopoietic Stem Cell Transplantation | 20 | participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hematopoietic Stem Cell Transplantation | 36 | |
| Overall Study | COMPLETED | Hematopoietic Stem Cell Transplantation | 36 | |
| Overall Study | NOT COMPLETED | Hematopoietic Stem Cell Transplantation | 0 |
Source ClinicalTrials.gov
Adverse events210
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 | abdominal cramping | Gastrointestinal disorders | Hematopoietic Stem Cell Transplantation | 12 | 36 | 12 |
| other | abdominal discomfort/tenderness | Gastrointestinal disorders | Hematopoietic Stem Cell Transplantation | 9 | 36 | 9 |
| other | abdominal distention | General disorders | Hematopoietic Stem Cell Transplantation | 2 | 36 | 2 |
| other | abdominal pain | Gastrointestinal disorders | Hematopoietic Stem Cell Transplantation | 16 | 36 | 16 |
| other | aggitation | Psychiatric disorders | Hematopoietic Stem Cell Transplantation | 2 | 36 | 2 |
| other | Alkaline Phosphatase | Investigations | Hematopoietic Stem Cell Transplantation | 22 | 36 | 22 |
| other | ALT | Hepatobiliary disorders | Hematopoietic Stem Cell Transplantation | 26 | 36 | 26 |
| other | anal/rectal erythema | Skin and subcutaneous tissue disorders | Hematopoietic Stem Cell Transplantation | 2 | 36 | 2 |
| other | ANC | Blood and lymphatic system disorders | Hematopoietic Stem Cell Transplantation | 29 | 36 | 29 |
| other | anemia | Blood and lymphatic system disorders | Hematopoietic Stem Cell Transplantation | 27 | 36 | 27 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hematopoietic Stem Cell Transplantation | ||
| Total, other adverse events | Hematopoietic Stem Cell Transplantation | 36 | 36 |
| Total, serious adverse events | Hematopoietic Stem Cell Transplantation | 10 | 36 |
Source ClinicalTrials.gov
Papers23
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/NCT00818961
GET https://conductscience.org/api/trials/v1/NCT00818961/events?page=2