TriangleNCT00787761 · STUDY IN CONTEXT
Early Administration of ATG Followed by Cyclophosphamide, Busulfan and Fludarabine Before a Donor Stem Cell Transplant in Patients With 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
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.
Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.
non-relapse mortality refers to the death of a patient for causes other than relapsed disease.
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-malignant-kidney-neoplasm
- nct id
- NCT00787761
- trial label
- Early Administration of ATG Followed by Cyclophosphamide, Busulfan and Fludarabine Before a Donor Stem Cell Transplant in Patients With 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-malignant-kidney-neoplasm
- nct id
- NCT00787761
- outcome key
- om-0000
- source section id
- NCT00787761-om-0000
- source outcome index
- 0
- endpoint
- Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation
- endpoint definition
- Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
- time origin
- Day 30
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- only 15 of the patients treated on study had Day 30 chimerism results.
- 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-malignant-kidney-neoplasm
- nct id
- NCT00787761
- outcome key
- om-0001
- source section id
- NCT00787761-om-0001
- source outcome index
- 1
- endpoint
- T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism)
- endpoint definition
- Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
- time origin
- Day 90
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 20 of the patients treated on this study had Day 90 chimerism drawn.
- 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-malignant-kidney-neoplasm
- nct id
- NCT00787761
- outcome key
- om-0002
- source section id
- NCT00787761-om-0002
- source outcome index
- 2
- endpoint
- T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%)
- endpoint definition
- Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
- time origin
- 180 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 20 of the patients treated on study had chimerism drawn on day 180.
- 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-malignant-kidney-neoplasm
- nct id
- NCT00787761
- outcome key
- om-0003
- source section id
- NCT00787761-om-0003
- source outcome index
- 3
- endpoint
- Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease
- endpoint definition
- number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.
- time origin
- Day 100
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 23 patients were able to be analyzed for severe gvhd
- 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-malignant-kidney-neoplasm
- nct id
- NCT00787761
- outcome key
- om-0004
- source section id
- NCT00787761-om-0004
- source outcome index
- 4
- endpoint
- Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD)
- endpoint definition
- Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.
- time origin
- 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 23 patients were able to be analyzed for severe gvhd
- 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-malignant-kidney-neoplasm
- nct id
- NCT00787761
- outcome key
- om-0005
- source section id
- NCT00787761-om-0005
- source outcome index
- 5
- endpoint
- Non-relapse Mortality (NRM) at Day 180 Post-transplantation
- endpoint definition
- non-relapse mortality refers to the death of a patient for causes other than relapsed disease.
- time origin
- Day 180
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 23 patients were able to be analyzed for NRM at 180 days
- 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-malignant-kidney-neoplasm
- nct id
- NCT00787761
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Transplant Recipients
- regimen
- patients receiving transplant using ATG/Bu/Flu/Cy per this protocol
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00787761-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT00787761
- outcome key
- om-0001
- arm key
- OG000
- arm label
- RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
- regimen
- All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 \& -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00787761-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT00787761
- outcome key
- om-0002
- arm key
- OG000
- arm label
- RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
- regimen
- All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 \& -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00787761-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT00787761
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Severe Graft Versus Host Disease
- regimen
- patients receiving transplant using ATG/Bu/Flu/Cy per this protocol and who had severe graft versus host disease as a post-transplant complication
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00787761-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT00787761
- outcome key
- om-0004
- arm key
- OG000
- arm label
- RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
- regimen
- All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 \& -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00787761-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT00787761
- outcome key
- om-0005
- arm key
- OG000
- arm label
- RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
- regimen
- All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 \& -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00787761-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT00787761
- harm key
- EG000
- source section id
- NCT00787761-ae
- event group key
- EG000
- event group label
- RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan
- serious affected
- 13
- serious at risk
- 24
- other affected
- 24
- other at risk
- 24
- frequency threshold
- 5
- collection period
- Source null
- 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