Trial · NCT00467961
Stem Cell Transplantation for Patients With Cancers of the Blood
NCT00467961, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2015-01-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stem Cell Transplantation for Patients With Cancers of the Blood. Trials, record NCT00467961. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00467961
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stem Cell Transplantation for Patients With Cancers of the Blood
- NCT number
- NCT00467961
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- CML (Chronic Myelogenous Leukemia), CLL (Chronic Lymphocytic Leukemia), AML (Acute Myelogenous Leukemia), Acute Lymphocytic Leukemia, MDS (Myelodysplastic Syndrome)
- Interventions
- Miltenyi system
- First posted
- 2007-05-01
- Last updated
- 2018-07-13
- Results first posted
- 2015-01-06
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Determine if Selective T Cell Depletion Using the Photodepletion Procedure Can Substantially Reduce the Rate of Severe Acute GVHD (Grade III/IV) After Matched Sibling Transplantation Followed by Low-dose or no Immunosuppression. | Day 90 | Patients will receive a selectively photodepleted lymphocyte product which will be delivered together with the T cell depleted stem cell product on the day of transplantation. Subjects will receive a conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34-selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized. To determine if selective T cell depletion using the photodepletion procedure can substantially reduce the number of severe acute GVHD (grade III/IV) after transplantation followed by low-dose or no immunosuppression. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Determine if Selective T Cell Depletion Using the Photodepletion Procedure Can Substantially Reduce the Rate of Severe Acute GVHD (Grade III/IV) After Matched Sibling Transplantation Followed by Low-dose or no Immunosuppression. | Day 90 | The study accrued 31 transplant recipents and 30 donors. Of the 31 transplant recipients, there were 24 evaluable recipients. Seven of the 24 recipients did not receive transplantation. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
To Determine if Selective T Cell Depletion Using the Photodepletion Procedure Can Substantially Reduce the Rate of Severe Acute GVHD (Grade III/IV) After Matched Sibling Transplantation Followed by Low-dose or no Immunosuppression. | Selective T Cell Depletion Transplant Recipients | Subjects affected by Acute Grade III/ IV GVHD | 3 | participants | |
To Determine if Selective T Cell Depletion Using the Photodepletion Procedure Can Substantially Reduce the Rate of Severe Acute GVHD (Grade III/IV) After Matched Sibling Transplantation Followed by Low-dose or no Immunosuppression. | Selective T Cell Depletion Transplant Recipients | Subjects unaffected by Acute Grade III/ IV GVHD | 21 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selective T Cell Depletion Transplant Recipients | 31 | |
| Overall Study | COMPLETED | Selective T Cell Depletion Transplant Recipients | 24 | |
| Overall Study | NOT COMPLETED | Selective T Cell Depletion Transplant Recipients | 7 |
Source ClinicalTrials.gov
Adverse events18
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 | Infection with normal absolute nuetrophil count | Infections and infestations | Selective T Cell Depletion Transplant Recipients | 3 | 31 | 3 |
| serious | Infection | Infections and infestations | Selective T Cell Depletion Transplant Recipients | 12 | 31 | 12 |
| serious | Infection with cytomegalovirus reactivation | Infections and infestations | Selective T Cell Depletion Transplant Recipients | 3 | 31 | 3 |
| serious | Febrile neutropenia | Infections and infestations | Selective T Cell Depletion Transplant Recipients | 1 | 31 | 1 |
| serious | Infection with neutropenic fever | Infections and infestations | Selective T Cell Depletion Transplant Recipients | 7 | 31 | 7 |
| serious | Infection cytomegalovirus gastritis | Infections and infestations | Selective T Cell Depletion Transplant Recipients | 1 | 31 | 1 |
| serious | pulmonary infection | Infections and infestations | Selective T Cell Depletion Transplant Recipients | 1 | 31 | 1 |
| serious | renal infection | Infections and infestations | Selective T Cell Depletion Transplant Recipients | 1 | 31 | 1 |
| serious | multiple opportunistic infection | Infections and infestations | Selective T Cell Depletion Transplant Recipients | 1 | 31 | 1 |
| serious | GVHD | Immune system disorders | Selective T Cell Depletion Transplant Recipients | 6 | 31 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selective T Cell Depletion Transplant Recipients | ||
| Total, other adverse events | Selective T Cell Depletion Transplant Recipients | 0 | 31 |
| Total, serious adverse events | Selective T Cell Depletion Transplant Recipients | 24 | 31 |
Source ClinicalTrials.gov
Papers6
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/NCT00467961
GET https://conductscience.org/api/trials/v1/NCT00467961/registered