Trial · NCT00378534
Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants
NCT00378534, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2015-01-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants. Trials, record NCT00378534. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00378534
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants
- NCT number
- NCT00378534
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 116 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- Interventions
- Miltenyi reagent system, Fludarabine, Cyclosporine, Cyclophosphamide, FILGRASTIM (G-CSF)
- First posted
- 2006-09-20
- Last updated
- 2021-06-16
- Results first posted
- 2015-01-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System | Day 200 | Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infusion at day 90. The subjects receiving allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse mortality at day +200. |
| Secondary | Number of Participants With Relapse of Disease | Day 200 | Number of participants with relapse of disease by day 200 |
| Secondary | Number of Participants Who Developed Acute GVHD Grades I, II, III, IV | 100 days | Number of participants who developed Acute Graft vs Host Disease (GVHD) Grades I, II, III, IV as defined by CIMBTR criteria for Organ Stages of Acute GVHD. Grades are defined as: Grade I: Skin = Maculopapular rash\< 25% of body surface area (BSA); Liver = Total Bilirubin 2-3 mg/dL; Lower GI = stool output/day is 500-999 mL/day. Grade II: Skin = rash on 25-50 percent body surface area; Liver = Total Bilirubin 3.1-6.0 mg/dL; Lower GI = Diarrhea 1001-1500 mL/day. Grade III: Skin = Rash on \>50% of body surface; Liver = Total Bilirubin 6.1 - 15.0 mg/dL; Lower GI = Diarrhea \> 1500 mL/day. Grade IV: Skin = Generalized erythroderma plus bullous formation; Liver = Total Bilirubin \>15 mg/dL; Lower GI = Severe abdominal pain with or without ileus. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. |
| Secondary | Number of Participants Who Developed Limited Chronic GVHD | 36 months | Number of incidences of participants who developed Limited Chronic Graft vs Host Disease (GVHD). Limited disease is characterized by localized skin involvement and/or evidence of hepatic dysfunction. Limited disease is associated with a favorable outcome without systemic therapy, while extensive disease patients have an unfavorable outcome. |
| Secondary | Number of Participants Who Develop Extensive GVHD | 36 months | Number of participants with extensive, Chronic Graft vs Host Disease (GVHD). Extensive chronic GVHD is defined as GVHD occurring after day 100 that did not meet the definition of limited chronic GVHD. Extensive disease presents either with generalized skin involvement, or with localized skin involvement or hepatic dysfunction plus at least one of the following: * Liver histology showing chronic progressive hepatitis, bridging necrosis, or cirrhosis * Involvement of the eye (Schirmer's test with less than 5 mm wetting) (see "Diagnosis and classification of Sjögren's syndrome") * Involvement of minor salivary glands or oral mucosa (as demonstrated on labial or mucosal biopsy specimen) * Involvement of any other target organ |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System | Day 200 | participants | NUMBER | |
| SECONDARY | Number of Participants With Relapse of Disease | Day 200 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Developed Acute GVHD Grades I, II, III, IV | 100 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Developed Limited Chronic GVHD | 36 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Develop Extensive GVHD | 36 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System | T Cell Depletion Transplant Participants | Survival at day 200 | 43 | participants | |
| Survival and Non-relapse Mortality at Day +200 Using the Miltenyi Reagent System | T Cell Depletion Transplant Participants | Non-relapse mortality | 4 | participants | |
| Number of Participants With Relapse of Disease | T Cell Depletion Transplant Participants | 17 | Participants | ||
| Number of Participants Who Developed Acute GVHD Grades I, II, III, IV | T Cell Depletion Transplant Participants | Acute GVHD, Grade I | 14 | Participants | |
| Number of Participants Who Developed Acute GVHD Grades I, II, III, IV | T Cell Depletion Transplant Participants | Acute GVHD, Grade II | 16 | Participants | |
| Number of Participants Who Developed Acute GVHD Grades I, II, III, IV | T Cell Depletion Transplant Participants | Acute GVHD, Grade III | 9 | Participants | |
| Number of Participants Who Developed Acute GVHD Grades I, II, III, IV | T Cell Depletion Transplant Participants | Acute GVHD, Grade IV | 1 | Participants | |
| Number of Participants Who Developed Limited Chronic GVHD | T Cell Depletion Transplant Participants | 8 | Participants | ||
| Number of Participants Who Develop Extensive GVHD | T Cell Depletion Transplant Participants | 18 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | T Cell Depletion Transplant Participants | 58 | |
| Overall Study | STARTED | Stem Cell Donors | 58 | |
| Overall Study | COMPLETED | T Cell Depletion Transplant Participants | 55 | |
| Overall Study | COMPLETED | Stem Cell Donors | 58 | |
| Overall Study | NOT COMPLETED | T Cell Depletion Transplant Participants | 3 | |
| Overall Study | NOT COMPLETED | Stem Cell Donors | 0 |
Source ClinicalTrials.gov
Adverse events20
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 | Graft failure | Blood and lymphatic system disorders | T Cell Depletion Transplant Participants | 3 | 58 | 3 |
| serious | Graft failure | Blood and lymphatic system disorders | Stem Cell Donors | 0 | 58 | |
| serious | Infection | Infections and infestations | T Cell Depletion Transplant Participants | 7 | 58 | 7 |
| serious | Infection | Infections and infestations | Stem Cell Donors | 0 | 58 | |
| serious | GVHD | Immune system disorders | T Cell Depletion Transplant Participants | 4 | 58 | 4 |
| serious | GVHD | Immune system disorders | Stem Cell Donors | 0 | 58 | |
| serious | Posterior reversible encephalopathy syndrome | Immune system disorders | T Cell Depletion Transplant Participants | 1 | 58 | 1 |
| serious | Posterior reversible encephalopathy syndrome | Immune system disorders | Stem Cell Donors | 0 | 58 | |
| serious | Hip fracture | Musculoskeletal and connective tissue disorders | T Cell Depletion Transplant Participants | 1 | 58 | 1 |
| serious | Hip fracture | Musculoskeletal and connective tissue disorders | Stem Cell Donors | 0 | 58 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T Cell Depletion Transplant Participants | 14 | 58 |
| Total, all-cause mortality | Stem Cell Donors | 0 | 58 |
| Total, other adverse events | T Cell Depletion Transplant Participants | 0 | 58 |
| Total, other adverse events | Stem Cell Donors | 0 | 58 |
| Total, serious adverse events | T Cell Depletion Transplant Participants | 14 | 58 |
| Total, serious adverse events | Stem Cell Donors | 0 | 58 |
Source ClinicalTrials.gov
Papers7
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| T Cell Depletion Transplant Participants vs Stem Cell Donors: deaths from any cause | Trial comparisons |
| T Cell Depletion Transplant Participants vs Stem Cell Donors: 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/NCT00378534
GET https://conductscience.org/api/trials/v1/NCT00378534/registered