TriangleNCT00589563 · STUDY IN CONTEXT
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment.
All patients were considered for the evaluation of the severity of acute GVHD.
Absolute neutrophil count (ANC) recovery is defined as an ANC of ≥ 0.5 x 10\^9/L (500/mm3) for three consecutive laboratory values obtained on different days
Platelet recovery is defined as the first date of three consecutive laboratory values ≥ 25 x 10\^9 L obtained on different days.
Participants were monitored throughout the trial (median of 28 months) for various infections/complications.
Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed TMA.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- trial label
- Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- outcome key
- om-0000
- source section id
- NCT00589563-om-0000
- source outcome index
- 0
- endpoint
- Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100
- endpoint definition
- Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment.
- time origin
- 100 Days Post Hematopoietic Stem Cell Transplant (HSCT)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- outcome key
- om-0001
- source section id
- NCT00589563-om-0001
- source outcome index
- 1
- endpoint
- Severity of Acute GVHD
- endpoint definition
- All patients were considered for the evaluation of the severity of acute GVHD.
- time origin
- 100 Days Post HSCT
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- outcome key
- om-0002
- source section id
- NCT00589563-om-0002
- source outcome index
- 2
- endpoint
- Time to Absolute Neutrophil Count Recovery (Engraftment)
- endpoint definition
- Absolute neutrophil count (ANC) recovery is defined as an ANC of ≥ 0.5 x 10\^9/L (500/mm3) for three consecutive laboratory values obtained on different days
- time origin
- Patients were evaluated until neutrophil recovery, a median of 15 days post HSCT
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 28 of the 32 patients had absolute neutrophil count recovery.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- outcome key
- om-0003
- source section id
- NCT00589563-om-0003
- source outcome index
- 3
- endpoint
- Time to Platelet Count Recovery (Engraftment)
- endpoint definition
- Platelet recovery is defined as the first date of three consecutive laboratory values ≥ 25 x 10\^9 L obtained on different days.
- time origin
- Patients were evaluated until platelet recovery, a median of 14 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 27 of the 32 patients had platelet recovery.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- outcome key
- om-0004
- source section id
- NCT00589563-om-0004
- source outcome index
- 4
- endpoint
- Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation
- endpoint definition
- Participants were monitored throughout the trial (median of 28 months) for various infections/complications.
- time origin
- Median Follow Up: 28 months (Range: 1-49 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- outcome key
- om-0005
- source section id
- NCT00589563-om-0005
- source outcome index
- 5
- endpoint
- Occurrence of Thrombotic Microangiopathy
- endpoint definition
- Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed TMA.
- time origin
- Median Follow Up: 28 Months (Range: 1-49 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- outcome key
- om-0000
- arm key
- OG000
- arm label
- All Patients
- regimen
- All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00589563-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- outcome key
- om-0001
- arm key
- OG000
- arm label
- All Patients
- regimen
- All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00589563-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- outcome key
- om-0002
- arm key
- OG000
- arm label
- All Patients
- regimen
- All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00589563-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- outcome key
- om-0003
- arm key
- OG000
- arm label
- All Patients
- regimen
- All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00589563-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- outcome key
- om-0004
- arm key
- OG000
- arm label
- All Patients
- regimen
- All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00589563-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- outcome key
- om-0005
- arm key
- OG000
- arm label
- All Patients
- regimen
- All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00589563-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer
- nct id
- NCT00589563
- harm key
- EG000
- source section id
- NCT00589563-ae
- event group key
- EG000
- event group label
- All Patients
- serious affected
- 9
- serious at risk
- 31
- other affected
- 31
- other at risk
- 31
- frequency threshold
- 0
- collection period
- 180 days
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice