Trial · NCT00929695
Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease
NCT00929695, Phase 3, Completed, Fred Hutchinson Cancer Center; results first posted 2014-10-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease. Trials, record NCT00929695. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00929695
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease
- NCT number
- NCT00929695
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 164 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
- Graft Versus Host Disease, Recurrent Adult Acute Lymphoblastic Leukemia
- Interventions
- prednisone, methylprednisolone, questionnaire administration
- First posted
- 2009-06-29
- Last updated
- 2017-08-21
- Results first posted
- 2014-10-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment | At day 42 after initiation of treatment | The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42. |
| Secondary | Prednisone-associated Toxicity as Assessed by Hyperglycemia | Baseline and then through 42 days after starting treatment | Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone. |
| Secondary | Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral) | Baseline and through 100 days of treatment | The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected. |
| Secondary | Prednisone-associated Toxicity as Assessed by Myopathy | Baseline and then weekly until 42 days after starting treatment | Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position. |
| Secondary | Prednisone-associated Toxicity as Assessed by Hypertension | Baseline and then through 42 days after starting treatment | The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured. |
| Secondary | Prednisone-associated Toxicity as Assessed by Quality of Life | Baseline and then every other week until 42 days after starting treatment | Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured. |
| Secondary | Non-relapse Mortality | At 12 months after the start of prednisone therapy | Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression. |
| Secondary | Recurrent or Progressive Malignancy | At 12 months after the start of prednisone therapy | Percentage of relapse estimated by cumulative incidence methods |
| Secondary | Progression to Grade III-IV Acute GVHD | At approximately 100 days after transplant | Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods. |
| Secondary | Secondary Therapy for Acute GVHD Beyond Prednisone | At approximately 100 days after transplant | This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment | At day 42 after initiation of treatment | From a total enrollment of 164 patients, the cumulative dose of prednisone at day 42 of treatment was available in 152 patients. The primary outcome was not measured in 12 patients due to withdrawal from study (2), discharge from Center before day 42 of treatment (10). Analysis was not completed in two patients due to an error in stratification. | milligrams per kilogram | MEAN |
| SECONDARY | Prednisone-associated Toxicity as Assessed by Hyperglycemia | Baseline and then through 42 days after starting treatment | mg/dL | MEAN | |
| SECONDARY | Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral) | Baseline and through 100 days of treatment | percentage of participants | NUMBER | |
| SECONDARY | Prednisone-associated Toxicity as Assessed by Myopathy | Baseline and then weekly until 42 days after starting treatment | units on a scale | MEAN | |
| SECONDARY | Prednisone-associated Toxicity as Assessed by Hypertension | Baseline and then through 42 days after starting treatment | medications | MEAN | |
| SECONDARY | Prednisone-associated Toxicity as Assessed by Quality of Life | Baseline and then every other week until 42 days after starting treatment | units on a scale | MEAN | |
| SECONDARY | Non-relapse Mortality | At 12 months after the start of prednisone therapy | percentage of participants | NUMBER | |
| SECONDARY | Recurrent or Progressive Malignancy | At 12 months after the start of prednisone therapy | percentage of participants | NUMBER | |
| SECONDARY | Progression to Grade III-IV Acute GVHD | At approximately 100 days after transplant | percentage of participants | NUMBER | |
| SECONDARY | Secondary Therapy for Acute GVHD Beyond Prednisone | At approximately 100 days after transplant | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment | Grade IIa GVHD; 0.5 mg/kg/d Prednisone | 22.2 | Standard Deviation 13.7 | milligrams per kilogram | |
| Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment | Grade IIa GVHD; 1.0 mg/kg/d Prednisone | 27.1 | Standard Deviation 12.7 | milligrams per kilogram | |
| Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment | Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone | 38.4 | Standard Deviation 14.1 | milligrams per kilogram | |
| Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment | Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone | 41.3 | Standard Deviation 12.1 | milligrams per kilogram | |
| Prednisone-associated Toxicity as Assessed by Hyperglycemia | Group A (Low-dose) | 140 | Standard Error 7.4 | mg/dL | |
| Prednisone-associated Toxicity as Assessed by Hyperglycemia | Group B (Standard-dose) | 142 | Standard Error 12.9 | mg/dL | |
| Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral) | Group A (Low-dose) | 52 | percentage of participants | ||
| Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral) | Group B (Standard-dose) | 53 | percentage of participants | ||
| Prednisone-associated Toxicity as Assessed by Myopathy | Group A (Low-dose) | -0.18 | Full Range -1.5 to 1.5 | units on a scale | |
| Prednisone-associated Toxicity as Assessed by Myopathy | Group B (Standard-dose) | -0.18 | Full Range -1.5 to 1.5 | units on a scale |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A (Low-dose) | 81 | |
| Overall Study | STARTED | Group B (Standard-dose) | 83 | |
| Overall Study | COMPLETED | Group A (Low-dose) | 73 | |
| Overall Study | COMPLETED | Group B (Standard-dose) | 77 | |
| Overall Study | NOT COMPLETED | Group A (Low-dose) | 8 | |
| Overall Study | NOT COMPLETED | Group B (Standard-dose) | 6 |
Source ClinicalTrials.gov
Adverse events58
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 | abdominal pain | Gastrointestinal disorders | Arm I (Low-dose) | 1 | 81 | 1 |
| serious | abdominal pain | Gastrointestinal disorders | Arm II (Standard-dose) | 1 | 83 | 1 |
| serious | peripheral edema | Cardiac disorders | Arm I (Low-dose) | 0 | 81 | 0 |
| serious | peripheral edema | Cardiac disorders | Arm II (Standard-dose) | 1 | 83 | 1 |
| serious | palpitations | Cardiac disorders | Arm I (Low-dose) | 1 | 81 | 1 |
| serious | palpitations | Cardiac disorders | Arm II (Standard-dose) | 0 | 83 | 0 |
| serious | graft versus host disease | Immune system disorders | Arm I (Low-dose) | 8 | 81 | 9 |
| serious | graft versus host disease | Immune system disorders | Arm II (Standard-dose) | 0 | 83 | 0 |
| serious | lethargy | Nervous system disorders | Arm I (Low-dose) | 0 | 81 | 0 |
| serious | lethargy | Nervous system disorders | Arm II (Standard-dose) | 1 | 83 | 1 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Low-dose) | ||
| Total, all-cause mortality | Arm II (Standard-dose) | ||
| Total, other adverse events | Arm I (Low-dose) | 0 | 0 |
| Total, other adverse events | Arm II (Standard-dose) | 0 | 0 |
| Total, serious adverse events | Arm I (Low-dose) | 38 | 81 |
| Total, serious adverse events | Arm II (Standard-dose) | 30 | 83 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P01CA018029 | Adult Leukemia Research Center | HILL, GEOFFREY ROGER | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Low-dose) vs Arm II (Standard-dose): serious adverse events |
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/NCT00929695
GET https://conductscience.org/api/trials/v1/NCT00929695/results?page=2