Trial · NCT00058825
Stem Cell Transplant for Hematologic Diseases
NCT00058825, Phase 1, Phase 2, Terminated, Baylor College of Medicine; results first posted 2015-10-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stem Cell Transplant for Hematologic Diseases. Trials, record NCT00058825. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00058825
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stem Cell Transplant for Hematologic Diseases
- NCT number
- NCT00058825
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Hematologic Malignancies
- Interventions
- Campath 1H, Fludarabine, Stem Cell Transplant, Total Body Irradiation (TBI), FK506 (Tacrolimus) or Cyclosporine
- First posted
- 2003-04-15
- Last updated
- 2016-11-07
- Results first posted
- 2015-10-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Transplant Related Mortality (TRM) | 100 days | Percentage of patients with transplant related mortality |
| Secondary | Time in Days to ANC Engraftment | 30 days | Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10\^9/L on the first of 3 days. |
| Secondary | Donor Chimerism Engraftment of Greater Than 50% | 30 days | Number of patients that engrafted who showed a chimerism (donor cells) of greater than 50% in the first 30 days |
| Secondary | Acute Graft Versus Host Disease | 100 days | Number of patients with Acute Graft Versus Host Disease within 100 days post-transplant |
| Secondary | Chronic Graft Versus Host Disease | 1 year | Number of patients with Chronic Graft Versus Host Disease within 1 year post-transplant |
| Secondary | 2-year Relapse-free Survival | 2 years | Relapse-free survival (RFS) was calculated from the time of transplant to the date of relapse, death, or last follow-up, whichever occurred first. Survival data were analyzed by Kaplan-Meier method. |
| Secondary | 2-year Overall Survival | 2 years | Overall survival (OS) was calculated from the time of transplant to death from any cause or censored at last follow-up. Survival data were analyzed by Kaplan-Meier method. |
| Secondary | Number of Patients Who Engrafted With the Isolex/CLINIMACs System | 30 days | Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10\^9/L on the first of 3 days. |
| Secondary | Median Time to Engraftment With the Isolex/CLINIMACs System | 30 days | Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10\^9/L on the first of 3 days. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Transplant Related Mortality (TRM) | 100 days | percentage of participants | NUMBER | |
| SECONDARY | Time in Days to ANC Engraftment | 30 days | days | MEDIAN | |
| SECONDARY | Donor Chimerism Engraftment of Greater Than 50% | 30 days | Patients engrafted | participants | NUMBER |
| SECONDARY | Acute Graft Versus Host Disease | 100 days | participants | NUMBER | |
| SECONDARY | Chronic Graft Versus Host Disease | 1 year | participants | NUMBER | |
| SECONDARY | 2-year Relapse-free Survival | 2 years | percentage of participants | NUMBER | |
| SECONDARY | 2-year Overall Survival | 2 years | percentage of participants | NUMBER | |
| SECONDARY | Number of Patients Who Engrafted With the Isolex/CLINIMACs System | 30 days | participants | NUMBER | |
| SECONDARY | Median Time to Engraftment With the Isolex/CLINIMACs System | 30 days | days | MEDIAN |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Transplant Related Mortality (TRM) | Stem Cell Transplant | 0 | 97.5% Confidence Interval 0 to 12.8 | percentage of participants | |
| Time in Days to ANC Engraftment | Stem Cell Transplant | 12 | Full Range 6 to 21 | days | |
| Donor Chimerism Engraftment of Greater Than 50% | Stem Cell Transplant | Yes | 20 | participants | |
| Donor Chimerism Engraftment of Greater Than 50% | Stem Cell Transplant | No | 2 | participants | |
| Acute Graft Versus Host Disease | Stem Cell Transplant | Grade 0 | 26 | participants | |
| Acute Graft Versus Host Disease | Stem Cell Transplant | Grade I | 0 | participants | |
| Acute Graft Versus Host Disease | Stem Cell Transplant | Grade II | 0 | participants | |
| Acute Graft Versus Host Disease | Stem Cell Transplant | Grade III | 1 | participants | |
| Acute Graft Versus Host Disease | Stem Cell Transplant | Grade IV | 0 | participants | |
| Chronic Graft Versus Host Disease | Stem Cell Transplant | Yes | 1 | participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stem Cell Transplant | 27 | |
| Overall Study | COMPLETED | Stem Cell Transplant | 5 | |
| Overall Study | NOT COMPLETED | Stem Cell Transplant | 22 |
Source ClinicalTrials.gov
Adverse events21
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 | Failure to engraft | Blood and lymphatic system disorders | Stem Cell Transplant | 4 | 27 | 4 |
| other | Transfusion: Platelets | Blood and lymphatic system disorders | Stem Cell Transplant | 7 | 27 | 16 |
| other | Anorexia | Gastrointestinal disorders | Stem Cell Transplant | 7 | 27 | 7 |
| other | Nausea | Gastrointestinal disorders | Stem Cell Transplant | 3 | 27 | 7 |
| other | Vomiting | Gastrointestinal disorders | Stem Cell Transplant | 2 | 27 | 5 |
| other | GGT (Gamma-Glutamyl transpeptidase) | Hepatobiliary disorders | Stem Cell Transplant | 3 | 27 | 5 |
| other | SGPT (ALT) (serum glutamic pyruvic transaminase) | Hepatobiliary disorders | Stem Cell Transplant | 2 | 27 | 4 |
| other | Catheter-related infection | Infections and infestations | Stem Cell Transplant | 2 | 27 | 3 |
| other | Febrile Neutropenia | Infections and infestations | Stem Cell Transplant | 3 | 27 | 3 |
| other | Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia | Infections and infestations | Stem Cell Transplant | 8 | 27 | 11 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stem Cell Transplant | ||
| Total, other adverse events | Stem Cell Transplant | 19 | 27 |
| Total, serious adverse events | Stem Cell Transplant | 4 | 27 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Isolex vs CLINIMACs: Number of Patients Who Engrafted With the Isolex/CLINIMACs System |
Source 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/NCT00058825
GET https://conductscience.org/api/trials/v1/NCT00058825/events?page=2