TriangleNCT00118352 · STUDY IN CONTEXT
Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant
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
Severity of Individual Organ Involvement Liver: Stage 2 - bilirubin (3-5.9mg/100ml) Stage 3 - bilirubin (6-14.9mg/100ml) Stage 4 - bilirubin \> 15mg/100ml Gut: Diarrhea is graded stage 1 to stage 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as stage 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall Severity of GVHD Grade III - Stage 2 to 4 gastrointestinal involvement and/or Stage 2 to 4 liver involvement with or without a rash Grade IV - Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
Percentage patients that experienced graft rejection.
Percentage patients requiring steroids greater than 1 mg/kg.
Percentage patient deaths due to non-relapse mortality
Percentage patients that experienced infection(s).
The outcome of immune reconstitution was not analyzed by the collaborating laboratory because only a small number of patients were only enrolled in Dose Level 1 (no alemtuzumab). The Dose Level 1 patients were going to be the baseline for which to compare the other patients on Dose Level 2 (and 3) who would have received alemtuzumab. The collaborating investigator determined that the study was not worthwhile performing based on this information.
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-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- trial label
- Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant
- 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
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0000
- source section id
- NCT00118352-om-0000
- source outcome index
- 0
- endpoint
- Incidence of Grade III-IV Acute GVHD
- endpoint definition
- Severity of Individual Organ Involvement Liver: Stage 2 - bilirubin (3-5.9mg/100ml) Stage 3 - bilirubin (6-14.9mg/100ml) Stage 4 - bilirubin \> 15mg/100ml Gut: Diarrhea is graded stage 1 to stage 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as stage 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall Severity of GVHD Grade III - Stage 2 to 4 gastrointestinal involvement and/or Stage 2 to 4 liver involvement with or without a rash Grade IV - Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
- time origin
- 100 days after transplant
- 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-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0001
- source section id
- NCT00118352-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Graft Rejection
- endpoint definition
- Percentage patients that experienced graft rejection.
- time origin
- 84 days after transplant
- 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-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0002
- source section id
- NCT00118352-om-0002
- source outcome index
- 2
- endpoint
- Incidence of High-dose Corticosteroid Utilization.
- endpoint definition
- Percentage patients requiring steroids greater than 1 mg/kg.
- time origin
- 100 days after transplant
- 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-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0003
- source section id
- NCT00118352-om-0003
- source outcome index
- 3
- endpoint
- Incidence of Non-relapse Mortality
- endpoint definition
- Percentage patient deaths due to non-relapse mortality
- time origin
- 100 days after transplant
- 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-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0004
- source section id
- NCT00118352-om-0004
- source outcome index
- 4
- endpoint
- Incidence of Infection
- endpoint definition
- Percentage patients that experienced infection(s).
- time origin
- Up to 5 years post-transplant
- 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-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0005
- source section id
- NCT00118352-om-0005
- source outcome index
- 5
- endpoint
- Immune Reconstitution
- endpoint definition
- The outcome of immune reconstitution was not analyzed by the collaborating laboratory because only a small number of patients were only enrolled in Dose Level 1 (no alemtuzumab). The Dose Level 1 patients were going to be the baseline for which to compare the other patients on Dose Level 2 (and 3) who would have received alemtuzumab. The collaborating investigator determined that the study was not worthwhile performing based on this information.
- time origin
- Up to 1 year post-transplant
- 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-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Dose Level 1 (No Campath)
- regimen
- Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00118352-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Dose Level 2 (40mg Total Dose Campath)
- regimen
- Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00118352-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Dose Level 3 (60mg Total Dose Campath)
- regimen
- Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00118352-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Dose Level 1 (No Campath)
- regimen
- Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00118352-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dose Level 2 (40mg Total Dose Campath)
- regimen
- Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00118352-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Dose Level 3 (60mg Total Dose Campath)
- regimen
- Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00118352-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Dose Level 1 (No Campath)
- regimen
- Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00118352-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dose Level 2 (40mg Total Dose Campath)
- regimen
- Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00118352-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Dose Level 3 (60mg Total Dose Campath)
- regimen
- Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00118352-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Dose Level 1 (No Campath)
- regimen
- Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00118352-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Dose Level 2 (40mg Total Dose Campath)
- regimen
- Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00118352-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Dose Level 3 (60mg Total Dose Campath)
- regimen
- Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00118352-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- harm key
- EG000
- source section id
- NCT00118352-ae
- event group key
- EG000
- event group label
- Dose Level 1 (No Campath)
- serious affected
- 2
- serious at risk
- 12
- other affected
- 7
- other at risk
- 12
- frequency threshold
- 0
- collection period
- AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- harm key
- EG001
- source section id
- NCT00118352-ae
- event group key
- EG001
- event group label
- Dose Level 2 (40mg Total Dose Campath)
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric
- nct id
- NCT00118352
- harm key
- EG002
- source section id
- NCT00118352-ae
- event group key
- EG002
- event group label
- Dose Level 3 (60mg Total Dose Campath)
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
- 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