Trial · NCT02806947
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete or Partial Response (CR/PR) to Acute GVHD Treatment | Days 28 and 56 Post-randomization | Scoring of CR/PR is in comparison to the participant's acute GVHD status at randomization. Complete response (CR) is defined as staging of 0 for in all target organs for GVHD - skin, GI tract, and liver. Partial response (PR) is defined as improvement in some target organ(s) without worsening in others. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are considered failures for this endpoint. Organ staging is defined below: Skin stage: 0: No rash 1. Rash \<25% of body surface area (BSA) 2. Rash on 25-50% of BSA 3. Rash on \>50% of BSA 4. Generalized erythroderma with bullous formation Liver stage (based on bilirubin level): 0: \<2 mg/dL 1. 2-3 mg/dL 2. 3.01-6 mg/dL 3. 6.01-15.0 mg/dL 4. \>15 mg/dL GI stage: 0: No diarrhea or diarrhea \<500 mL/day 1. Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD 2. Diarrhea 1000-1499 mL/day 3. Diarrhea \>1500 mL/day 4. Severe abdominal pain with or without ileus |
| Secondary | Percentage of Participants With Complete or Partial Response (CR/PR) and Steroid Dose Less Than 0.25 mg/kg Per Day | Day 28 Post-randomization | The proportion of patients with CR/PR and on a prednisone-equivalent steroid dose of 0.25 mg/kg/day or less is evaluated. CR/PR scoring is in comparison to acute GVHD status at randomization. CR is defined as staging of 0 in all target organs. PR is defined as improvement in some organ(s) without worsening in others. Death and initiation of steroid-free, systemic acute GVHD treatment beyond randomized therapy are considered failures for this endpoint. Organ staging is defined as: Skin stage: 0: No rash 1. Rash \<25% of body surface area (BSA) 2. Rash 25-50% of BSA 3. Rash \>50% of BSA 4. Generalized erythroderma with bullous formation Liver stage (based on bilirubin level in mg/dL): 0: \<2 1. 2-3 2. 3.01-6 3. 6.01-15.0 4. \>15 mg/dL GI stage: 0: No diarrhea or diarrhea \<500 mL/day 1. Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD 2. Diarrhea 1000-1499 mL/day 3. Diarrhea \>1500 mL/day 4. Severe abdominal pain with or without ileus |
| Secondary | Acute GVHD Response | Days 28 and 56 Post-randomization | Acute GVHD response is classified as CR, PR, mixed response (MR), no response (NR), and progression and scored by comparison to acute GVHD status at randomization. MR is defined as improvement in some organ(s) with worsening in another, progression as worsening in some organ(s) without improvement in others, and NR as absence of any improvement or worsening. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are classified as NR. Organ staging is defined as: Skin stage: 0: No rash 1. Rash \<25% of body surface area (BSA) 2. Rash 25-50% of BSA 3. Rash \>50% of BSA 4. Generalized erythroderma with bullous formation Liver stage (based on bilirubin level in mg/dL): 0: \<2 1. 2-3 2. 3.01-6 3. 6.01-15.0 4. \>15 GI stage: 0: No diarrhea or diarrhea \<500 mL/day 1. Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD 2. Diarrhea 1000-1499 mL/day 3. Diarrhea \>1500 mL/day 4. Severe abdominal pain with or without ileus |
| Secondary | Percentage of Participants With Treatment Failure | Days 28 and 56 Post-randomization | Treatment failure is defined as either no response (NR) or progression and scored by comparison to acute GVHD status at randomization. Progression is defined as worsening in some target organ(s) without improvement in others and NR is defined as absence of any improvement or worsening in target organs. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are classified as NR. Organ staging is defined as: Skin stage: 0: No rash 1. Rash \<25% of body surface area (BSA) 2. Rash 25-50% of BSA 3. Rash \>50% of BSA 4. Generalized erythroderma with bullous formation Liver stage (based on bilirubin level in mg/dL): 0: \<2 1. 2-3 2. 3.01-6 3. 6.01-15.0 4. \>15 GI stage: 0: No diarrhea or diarrhea \<500 mL/day 1. Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD 2. Diarrhea 1000-1499 mL/day 3. Diarrhea \>1500 mL/day 4. Severe abdominal pain with or without ileus |
| Secondary | Percentage of Participants With Overall Survival | 6 and 12 Months Post-randomization | Overall survival is defined as survival of death from any cause. |
| Secondary | Percentage of Participants With Disease-free Survival | 6 and 12 Months Post-randomization | Disease-free survival is defined as freedom from death and relapse of the underlying malignancy. |
| Secondary | Proportion of Participants With Event-free Survival | 6 and 12 Months Post-randomization | Event-free survival is defined as freedom from acute GVHD progression, chronic GVHD, malignancy relapse, and death. |
| Secondary | Percentage of Participants With Non-relapse Mortality | 6 and 12 Months Post-randomization | Non-relapse mortality is defined as death due to any cause other than relapse of the underlying malignancy. The cumulative incidence of non-relapse mortality is described, with malignancy relapse treated as a competing risk. |
| Secondary | Percentage of Participants With Malignancy Relapse | 6 and 12 Months Post-randomization | The cumulative incidence of relapse of the primary malignancy is described, with death treated as a competing risk. |
| Secondary | Percentage of Participants With Chronic GVHD | 6 and 12 Months Post-randomization | Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. The cumulative incidence of chronic GVHD is described, with death and malignancy relapse treated as competing risks. |
| Secondary | Percentage of Participants With GVHD-free Survival | 6 and 12 Months Post-randomization | GVHD-free survival is defined as freedom from acute GVHD, chronic GVHD, and death. The proportion of participants alive and free of both acute and chronic GVHD are described at 6 and 12 months post-randomization. |
| Secondary | Percentage of Participants With Serious Infections | 6 and 12 Months Post-randomization | The cumulative incidence of serious infections (Grade 2 or 3 per BMT CTN MOP) is described, with death treated as a competing risk. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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