Trial · NCT00603954
Allogeneic HCT With HLA-matched Donors : a Phase II Randomized Study Comparing 2 Nonmyeloablative Conditionings
NCT00603954, Phase 2, Completed, University of Liege; results first posted 2022-01-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Allogeneic HCT With HLA-matched Donors : a Phase II Randomized Study Comparing 2 Nonmyeloablative Conditionings. Trials, record NCT00603954. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00603954
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Allogeneic HCT With HLA-matched Donors : a Phase II Randomized Study Comparing 2 Nonmyeloablative Conditionings
- NCT number
- NCT00603954
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- University of Liege
- Conditions
- Hematological Malignancies
- Interventions
- Conditioning regimen: TBI + Fludarabine, Conditioning regimen:TLI (8 Gy) + ATG
- First posted
- 2008-01-29
- Last updated
- 2022-01-26
- Results first posted
- 2022-01-26
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups | 180 days after HCT | Percentage of participants with aGVHD according grades: Grade I: rash skin \< 25 % area; bilirubin: 20-30 mg/ml; diarrhea: 500-1000 ml/day Grade II: rash skin 25-50 % area; bilirubin: 30-60 mg/ml; diarrhea: 10000-1500 ml/day Grade III:rash skin \> 50 % area; bilirubin: 60-150 mg/ml; diarrhea: \>1500 ml/day Grade IV: erythroderma; bilirubin: \> 150 mg/ml; diarrhea: \>2000 ml/day Grade IV is the worst grade Patients given a second allogeneic HCT were censured for GVHD analyses. |
| Secondary | Number of Participants With Graft Rejection as Defined by Whole Blood and T Cell Chimerism | 1 year after HCT | graft rejection are reported in outcome measure data table (defined as ≤ 5% donor chimerism in T cells, total white blood cells and/or total bone marrow cells). |
| Secondary | Percentage of Participants With Chronic GVHD in the 2 Groups | 2 years after HCT | Comparaison of the number of Participants with chronic GVHD in the 2 groups |
| Secondary | Incidences of Bacterial, Fungal and Viral Infections in the 2 Groups. | D100 after HCT | |
| Secondary | Percentage of Relapse Rate in the 2 Groups | 1 year after HCT | |
| Secondary | Quality and Timing of Immunologic Reconstitution: Concentration of ATG Levels | Day 0, Day 3 and Day 10 | Analyses of ATG levels in order to assess the immune system recuperation |
| Secondary | Percentage of Non Relapse Mortality in the 2 Groups | 1 year after HCT | |
| Secondary | Percentage of 4-year Progression Free Survival in the 2 Groups | 4 year after HCT | |
| Secondary | Percentage of 5-year Progression Free Survival in the 2 Groups | 5 year after HCT | |
| Secondary | Percentage of 4-year Overall Survival in the 2 Groups | 4 year after HCT |
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 | Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups | 180 days after HCT | Patients given a second allogeneic HCT were censured for GVHD analyses. | percentage of participants with aGVHD | NUMBER |
| SECONDARY | Number of Participants With Graft Rejection as Defined by Whole Blood and T Cell Chimerism | 1 year after HCT | participants | NUMBER | |
| SECONDARY | Percentage of Participants With Chronic GVHD in the 2 Groups | 2 years after HCT | Patients given a second allogeneic HCT were censured for GVHD analyses. | percentage of participants | NUMBER |
| SECONDARY | Incidences of Bacterial, Fungal and Viral Infections in the 2 Groups. | D100 after HCT | participants | NUMBER | |
| SECONDARY | Percentage of Relapse Rate in the 2 Groups | 1 year after HCT | percentage of Relapse | NUMBER | |
| SECONDARY | Quality and Timing of Immunologic Reconstitution: Concentration of ATG Levels | Day 0, Day 3 and Day 10 | mg/L | MEDIAN | |
| SECONDARY | Percentage of Non Relapse Mortality in the 2 Groups | 1 year after HCT | percentage of participants | NUMBER | |
| SECONDARY | Percentage of 4-year Progression Free Survival in the 2 Groups | 4 year after HCT | percentage of participants | NUMBER | |
| SECONDARY | Percentage of 5-year Progression Free Survival in the 2 Groups | 5 year after HCT | percentage of participants | NUMBER | |
| SECONDARY | Percentage of 4-year Overall Survival in the 2 Groups | 4 year after HCT | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups | Flu-TBI | 12.2 | percentage of participants with aGVHD | ||
| Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups | TLI-ATG | 8.9 | percentage of participants with aGVHD | ||
| Number of Participants With Graft Rejection as Defined by Whole Blood and T Cell Chimerism | Flu-TBI | 3 | participants | ||
| Number of Participants With Graft Rejection as Defined by Whole Blood and T Cell Chimerism | TLI-ATG | 4 | participants | ||
| Percentage of Participants With Chronic GVHD in the 2 Groups | Flu-TBI | 40.8 | percentage of participants | ||
| Percentage of Participants With Chronic GVHD in the 2 Groups | TLI-ATG | 18.8 | percentage of participants | ||
| Incidences of Bacterial, Fungal and Viral Infections in the 2 Groups. | Flu-TBI | Bacterial infection | 19 | participants | |
| Incidences of Bacterial, Fungal and Viral Infections in the 2 Groups. | TLI-ATG | Bacterial infection | 25 | participants | |
| Incidences of Bacterial, Fungal and Viral Infections in the 2 Groups. | Flu-TBI | Fungal infection | 3 | participants | |
| Incidences of Bacterial, Fungal and Viral Infections in the 2 Groups. | TLI-ATG | Fungal infection | 7 | participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Flu-TBI | 50 | |
| Overall Study | STARTED | TLI-ATG | 47 | |
| Overall Study | COMPLETED | Flu-TBI | 49 | |
| Overall Study | COMPLETED | TLI-ATG | 45 | |
| Overall Study | NOT COMPLETED | Flu-TBI | 1 | |
| Overall Study | NOT COMPLETED | TLI-ATG | 2 |
Source ClinicalTrials.gov
Adverse events46
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 | CMV reactivation | Infections and infestations | Flu-TBI | 15 | 49 | |
| other | CMV reactivation | Infections and infestations | TLI-ATG | 21 | 45 | |
| serious | acute Graft versus Host Disease | Immune system disorders | Flu-TBI | 5 | 49 | |
| serious | acute Graft versus Host Disease | Immune system disorders | TLI-ATG | 5 | 45 | |
| serious | chronic Graft versus Host Disease | Immune system disorders | Flu-TBI | 20 | 49 | |
| serious | chronic Graft versus Host Disease | Immune system disorders | TLI-ATG | 13 | 45 | |
| serious | Graft failure | Blood and lymphatic system disorders | Flu-TBI | 3 | 49 | |
| serious | Graft failure | Blood and lymphatic system disorders | TLI-ATG | 4 | 45 | |
| serious | Relapse/progression | Blood and lymphatic system disorders | Flu-TBI | 12 | 49 | |
| serious | Relapse/progression | Blood and lymphatic system disorders | TLI-ATG | 22 | 45 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Flu-TBI | 22 | 49 |
| Total, all-cause mortality | TLI-ATG | 19 | 45 |
| Total, other adverse events | Flu-TBI | 15 | 49 |
| Total, other adverse events | TLI-ATG | 21 | 45 |
| Total, serious adverse events | Flu-TBI | 41 | 49 |
| Total, serious adverse events | TLI-ATG | 41 | 45 |
Source ClinicalTrials.gov
Papers2
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Flu-TBI vs TLI-ATG: Number of Participants With Graft Rejection as Defined by Whole Blood and T Cell Chimerism | Trial comparisons |
| Flu-TBI vs TLI-ATG: deaths from any cause | Trial comparisons |
| Flu-TBI vs TLI-ATG: 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/NCT00603954
GET https://conductscience.org/api/trials/v1/NCT00603954/results?page=2